| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA Date example | IGALMI® (dexmedetomidine) Acute treatment of agitation associated with bipolar disorders, schizophrenia BreakthroughFast Track | PDUFA | — | Subscribe to access the data. | Small Molecules | Psychiatric Disorders | |
PDUFA Date example | IGALMI® (dexmedetomidine) Acute treatment of agitation associated with bipolar disorders, schizophrenia BreakthroughFast Track | PDUFA | — | Subscribe to access the data. | Small Molecules | Psychiatric Disorders | |
PDUFA Date example | IGALMI® (dexmedetomidine) Acute treatment of agitation associated with bipolar disorders, schizophrenia BreakthroughFast Track | PDUFA | — | Subscribe to access the data. | Small Molecules | Psychiatric Disorders |
Recent Updates
Recently added Catalysts
BioXcel Therapeutics, Inc.$0.82
-0.02 (-2.42%)
D 36Pipeline Score Overvalued Biotech · Clinical
Market Cap
34.89 M
EPS
-6.19
P/E Ratio
-
Value Trade
388.11 K
SEC Financials
Q1 2026Dilution Risk
Revenue
206.00 K
R&D Expenses
2.96 M
Operating CF
-11.81 M
Total Assets
34.02 M
Total Liabilities
139.57 M
Equity
-105.54 M
D/E Ratio
12,345
-3.42 %
Week
-3.42 %
1 Month
-28.93 %
3 Month
-35.43 %
6 Month
-99.78 %
5 Year
-99.36 %
All Time
Cash Data
Cash Position
17.18 M
Monthly Burn
3.94 M
Runway
2.5 mo
Burn Trend
SEC Filing
May 15, 2026
Overview
Volume
712.11 K
52 Week Range
1.01 - 8.08
% held by Insiders
4.63 %
% held by Institutions
18.72 %
Enterprise Value
118.00 M
Total Shares
27.07 M
Short %
14.02 %
Float Shares
26.13 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for BioXcel Therapeutics, Inc.
561Total events
4Upcoming
131Tier-1 (high impact)
2016 – 2026Coverage
Upcoming catalysts 4
TBD
T3Additional Data
Complete analyses of full data set ongoing; results to be shared in near future
Event history 557
May 28, 2026
▲Poster PresentationBXCL501Presentation
Poster presentation of new exploratory efficacy data from SERENITY At-Home Phase 3 trial at 2026 ASCP Annual Meeting
agitation associated with bipolar disorders or schizophreniasource ↗
Apr 23, 2026
◆Oral PresentationPresentation
Virtual event to discuss commercial launch plan for IGALMI in at-home setting
Apr 8, 2026
▲First Patient DosedBXCL501Trial
Enrollment of first patients in DoW-funded Phase 2a trial of BXCL501 for ASR
acute stress reactions (ASR)source ↗
Apr 1, 2026
▲FDA Filing AcceptedIGALMIApprovedRegulatory Filing
FDA acceptance of sNDA for IGALMI at-home use
acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home settingsource ↗
Mar 2026
▲FDA Filing AcceptedIGALMIApprovedRegulatory Filing
FDA accepted sNDA for IGALMI at-home use
acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home settingsource ↗
Mar 27, 2026
▲Topline ReadoutBXCL501Clinical Data
Positive Phase 2 topline results from IST for opioid withdrawal
opioid withdrawal symptoms in adults with opioid use disordersource ↗
Mar 10, 2026
▼Equity OfferingCorporate
Registered direct offering of 4,500,785 shares and warrants for ~$8.0 million gross proceeds
Mar 5, 2026
▲Topline ReadoutBXCL501Clinical Data
Positive Phase 2 topline results for BXCL501 in opioid withdrawal
opioid withdrawal symptoms in adults with opioid use disorder (OUD) undergoing a methadone tapersource ↗
Mar 5, 2026
●Trial CompletionBXCL501Trial
Trial completed after 80 patients enrolled
opioid withdrawal symptoms in adults with OUD undergoing a methadone tapersource ↗
Drug Pipeline Intelligence
D36
Pipeline Score $24M
Pipeline ValueOvervalued
Valuation Signal6
Drugs Scored0.7x
rNPV / MCap Top 50%
Micro Cap (rank 457 of 912)
Percentile RankBioXcel Therapeutics, Inc. faces pipeline headwinds (36/100), with $1.8B risk-adjusted pipeline value, led by BXCL501 in Agitation,Psychomotor (Phase 3), across $56B in total addressable markets, but cash runway is a concern.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BXCL501 Small molecule | Agitation,Psychomotor | Phase 3 | NCT05658510 | 76% | $844M | COMPLETED | 452 | - | - | Aug 15, 2025 | - | Sep 18, 2025 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
BXCL501 BreakthroughFast Track | agitation associated with bipolar disorders or schizophrenia | Phase 3 | 2026-05-28 | BXCL501 significantly reduced agitation across various severity levels, with the most notable effects in severe cases. Read More | BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting Read More | |
BXCL501 BreakthroughFast Track | agitation associated with bipolar disorders or schizophrenia | Phase 3 | 2026-05-28 | BXCL501 significantly reduced agitation across various severity levels, with the most notable effects in severe cases. Read More | BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting Read More | |
BXCL501 BreakthroughFast Track | agitation associated with bipolar disorders or schizophrenia | Phase 3 | 2026-05-28 | BXCL501 significantly reduced agitation across various severity levels, with the most notable effects in severe cases. Read More | BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in BTAI
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
BTAI Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
BTAIBioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting
BioXcel Therapeutics presented new data from the Phase 3 SERENITY At-Home trial at the 2026 ASCP Annual Meeting. The trial evaluated BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in an at-home setting. Results indicated that BXCL501 significantly reduced agitation across various severity levels, with the most notable effects in severe cases. The FDA has set a target action date of November 14, 2026, for the supplemental New Drug Application for BXCL501.
Read more →BTAI▼ -5.8%on this news
BioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results
BioXcel Therapeutics announced the FDA's acceptance of its supplemental New Drug Application for IGALMI, aimed at treating agitation in bipolar disorder and schizophrenia in an at-home setting, with a PDUFA date set for November 14, 2026. The company is also advancing BXCL501 for Alzheimer's agitation and exploring strategic options to enhance shareholder value. Despite a slight increase in net losses, the company is focused on launching IGALMI and preparing for its commercial rollout.
Read more →BTAI▲ +7.5%on this news
BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home Setting
BioXcel Therapeutics is hosting a virtual event on April 23 to discuss its commercial launch plan for IGALMI, targeting the treatment of acute agitation in bipolar disorders and schizophrenia. The event will highlight insights from a market opportunity assessment that identified a substantial addressable market of 86 million episodes annually in the at-home setting. The company aims to advance its strategy ahead of the November 14 PDUFA target action date.
Read more →BTAIBioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions
BioXcel Therapeutics has announced the enrollment of the first patients in a Phase 2a clinical trial funded by the U.S. Department of War, aimed at evaluating BXCL501 for treating acute stress reactions. The trial, conducted by the University of North Carolina at Chapel Hill, will examine the effects of BXCL501 on symptom severity and cognitive function in patients following traumatic events. Positive results could influence clinical practice guidelines and provide a pharmacological treatment option for a large population affected by stress disorders.
Read more →BTAI▼ -9%on this news
BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI in the At-Home Setting
BioXcel Therapeutics has announced that the FDA has accepted its Supplemental New Drug Application (sNDA) for IGALMI, proposing its use in the at-home treatment of agitation associated with bipolar disorders and schizophrenia. This marks a potential first FDA-approved option for managing such conditions at home. The target action date for FDA review is set for November 14, 2026. BioXcel aims to address the therapeutic needs of millions of patients and caregivers facing agitation episodes in their daily lives.
Read more →BTAI▼ -8%on this newsshared move
BioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient Setting
BioXcel Therapeutics reported its financial results for Q4 and full-year 2025, highlighting a supplemental New Drug Application (sNDA) for IGALMI in the outpatient setting. The company anticipates potential approval by late 2026, supported by a significant market opportunity assessment. Despite a decrease in net revenue and increased operating losses, the company is advancing its commercial launch plans.
Read more →BTAIBioXcel Therapeutics Announces Closing of $8.0 Million Registered Direct Offering
BioXcel Therapeutics has successfully completed a registered direct offering, raising approximately $8.0 million through the sale of 4,500,785 shares of common stock and accompanying warrants. The new offering and adjustments to existing warrant prices reflect the company's commitment to strengthening its financial foundation. Rodman & Renshaw LLC served as the exclusive placement agent for the transaction, which adds capital to support BioXcel's neuroscience-focused drug development initiatives.
Read more →BTAI▼ -10.4%on this newsshared move
BioXcel Therapeutics Announces Approximately $8.0 Million Registered Direct Offering
BioXcel Therapeutics has announced a registered direct offering resulting in approximately $8.0 million in gross proceeds, with an institutional investor purchasing 4.5 million shares at $1.739 each. Additionally, the company will reduce the exercise price of existing warrants to $1.614, enhancing the attractiveness of its offering. The closing of the transaction is anticipated on or about March 11, 2026, subject to standard closing conditions.
Read more →BTAIBioXcel Therapeutics Announces Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid Withdrawal
BioXcel Therapeutics announced positive topline results from a Phase 2 trial of BXCL501 for opioid withdrawal treatment. The study indicated that BXCL501 may be as effective or superior to lofexidine, with a more convenient dosing regimen and fewer cardiovascular effects. The results support BXCL501's potential for future development in managing opioid withdrawal symptoms.
Read more →BTAIBioXcel Therapeutics to Host Virtual Roundtable Featuring Leading Medical Experts Addressing Latest Developments in Treatment of Acute Agitation in Alzheimer’s Dementia
BioXcel Therapeutics, Inc. will host a virtual KOL roundtable on February 27 to discuss acute agitation in Alzheimer's dementia, a condition affecting approximately 100 million episodes annually. The event aims to raise awareness about the need for FDA-approved treatment options. Panelists will explore the potential of BXCL501, an investigational treatment, which is currently preparing for the TRANQUILITY In-Care Phase 3 trial to evaluate its efficacy and safety. The discussion will include insights from leading medical experts in the field.
Read more →BTAIBioXcel Therapeutics Completes Market Opportunity Assessment and Advances Commercialization Plans for IGALMI® in the At-Home Setting
BioXcel Therapeutics has completed a market opportunity assessment for IGALMI, indicating a significant potential for its use in treating acute agitation in bipolar disorder and schizophrenia at home. The assessment, informed by the SERENITY At-Home clinical study, highlights strong prescriber interest and positive payer feedback. A supplemental New Drug Application has been submitted to the FDA for approval of IGALMI in this setting.
Read more →BTAIBioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting
BioXcel Therapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for IGALMI, aiming to expand its use for treating agitation associated with bipolar disorders and schizophrenia in outpatient settings. This submission follows the successful Phase 3 SERENITY At-Home trial, which demonstrated IGALMI's safety in non-supervised environments. If approved, this could provide a critical treatment option for millions of patients experiencing agitation.
Read more →BTAIBioXcel Therapeutics Expands Leadership Team to Prepare for Launch of IGALMI in the At-Home Setting
BioXcel Therapeutics has appointed Mark Pavao as Interim Chief Commercial Officer to help advance the commercial planning for the launch of IGALMI in an at-home setting. The company is set to submit a supplemental New Drug Application (sNDA) this month to gain FDA approval for IGALMI in treating agitation related to bipolar disorders and schizophrenia. This strategic move is expected to enhance patient access and convenience, with a targeted launch as early as year-end 2026.
Read more →BTAI▲ +17.2%on this newsshared move
BioXcel Therapeutics Planning to Submit sNDA This Month Seeking FDA Approval for At-Home Use of IGALMI
BioXcel Therapeutics plans to submit a supplemental New Drug Application for IGALMI, seeking FDA approval for its at-home use in treating agitation linked to bipolar disorders and schizophrenia. The company highlights the need for this treatment option, given that no FDA-approved alternatives currently exist. If approved, IGALMI could be available for patient use as early as 2026. However, there are concerns regarding the safety, efficacy, and potential side effects associated with IGALMI and its investigational formulation BXCL501.
Read more →BTAI▼ -15.3%on this news
BioXcel Therapeutics Reports Third Quarter 2025 Financial Results and Provides Update on Late-Stage Clinical Programs for Agitation in Bipolar, Schizophrenia, and Alzheimer’s Disease
BioXcel Therapeutics reported its third quarter 2025 financial results, highlighting plans to submit a supplemental New Drug Application for IGALMI's at-home use. The company is also advancing its late-stage clinical programs for BXCL501, targeting agitation in bipolar disorder, schizophrenia, and Alzheimer's dementia. Despite a decrease in revenue and increased operating losses, BioXcel remains focused on preparing for commercial readiness.
Read more →BTAI▲ +5.5%on this newsshared move
BXCL501 (Sublingual Dexmedetomidine) for Treatment of Agitation Associated With Bipolar Disorder or Schizophrenia in the Home Setting: a Phase 3 Study Leslie Citrome1 , Lavanya Rajachandran 2 , Robert Risinger 3 , Michae
The SERENITY AT-Home Phase 3 study evaluated the safety and efficacy of BXCL501, a sublingual dexmedetomidine formulation, for treating agitation in patients with bipolar disorder or schizophrenia in a home setting. The study involved 208 patients and monitored 2437 agitation episodes over 12 weeks. Results showed that BXCL501 was safe and well-tolerated, and patients experienced significantly greater resolution of agitation compared to those on placebo. Additionally, adverse event rates were similar to those seen in previous studies conducted under medical supervision, with no increase in adverse events during repeated dosing.
Read more →BTAIBioXcel Therapeutics Announces Positive Results from Correlation Study Supporting SERENITY At-Home Exploratory Efficacy Outcomes
BioXcel Therapeutics announced positive results from a correlation study related to the SERENITY At-Home trial. The study demonstrated a strong correlation between clinician assessments and patient or caregiver ratings of efficacy. These findings will be included in a supplemental New Drug Application (sNDA) planned for submission in early 2026. The safety profile of BXCL501 remains consistent with existing data.
Read more →BTAIBioXcel Therapeutics to Ring Nasdaq Closing Bell on October 14 to Celebrate a Transformative Milestone in Neuroscience Innovation
BioXcel Therapeutics will ring the Nasdaq closing bell on October 14, 2025, to celebrate its advancements in neuroscience. CEO Vimal Mehta highlighted the company's commitment to addressing agitation in bipolar disorder and schizophrenia. The event marks a pivotal moment following the successful SERENITY At-Home trial, aiming to redefine agitation management.
Read more →BTAIBioXcel Therapeutics Regains Compliance with Nasdaq Market Value of Listed Securities Requirements
BioXcel Therapeutics, Inc. has announced that it has regained compliance with Nasdaq's market value of listed securities requirement. This follows a previous notification in March 2025 regarding non-compliance due to a market value below $35 million. After a hearing, the company received an exception and confirmed compliance on September 17, 2025.
Read more →BTAIBioXcel Therapeutics Reports Positive Topline Exploratory Efficacy Data from SERENITY At-Home Pivotal Phase 3 Safety Trial for Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics announced positive topline results from the SERENITY At-Home Phase 3 trial, showing that BXCL501 significantly reduced agitation symptoms in patients with bipolar disorders or schizophrenia. The trial demonstrated a higher rate of complete resolution of agitation compared to placebo and maintained efficacy with repeat dosing. The company plans to submit a supplemental NDA for expanded outpatient use in early 2026.
Read more →BTAIBioXcel Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference
BioXcel Therapeutics, Inc. will present an overview at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025. CEO Vimal Mehta will discuss the company's innovative approach utilizing artificial intelligence in neuroscience and the development of medicines in immuno-oncology. The event aims to attract investor interest and provide updates on their ongoing projects.
Read more →BTAI▼ -24.4%on this news
UPDATE -- BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®
BioXcel Therapeutics announced that its SERENITY At-Home Phase 3 trial for BXCL501 successfully met its primary endpoint, demonstrating safety in treating agitation episodes in bipolar disorder and schizophrenia patients at home. The company plans to submit a supplemental New Drug Application (sNDA) for label expansion in early 2026, highlighting the significant unmet medical need in this area. The trial involved over 2400 agitation episodes, indicating a larger potential market for BXCL501.
Read more →BTAI▼ -24.4%on this newsshared move
BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI
BioXcel Therapeutics announced the successful outcome of the SERENITY At-Home Phase 3 trial, where BXCL501 demonstrated well-tolerated treatment of agitation in patients with bipolar disorders or schizophrenia. The trial's results, noting no discontinuations due to tolerability, will support the company's sNDA submission for expanded usage in outpatient settings. The trial treated over 2400 episodes, highlighting a substantial market opportunity. The company plans to submit this regulatory filing in the first quarter of 2026.
Read more →BTAIBioXcel Therapeutics To Announce Topline Results from SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia on August 27, 2025
BioXcel Therapeutics, Inc. has scheduled an investor call for August 27, 2025, to review topline results from its SERENITY At-Home Phase 3 trial. The trial evaluates the safety of BXCL501, a sublingual formulation of dexmedetomidine, for treating agitation in patients with bipolar disorders or schizophrenia. This call will share crucial data on BXCL501's use at home, with results being available through a press release and webcast. The trial engaged 200 participants who self-administered the medication during agitation episodes.
Read more →BTAI▼ -13.2%on this news
BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics has announced the completion of the database lock for its SERENITY At-Home pivotal Phase 3 safety trial, aimed at treating agitation associated with bipolar disorders or schizophrenia. The trial, which involves over 2,600 agitation episodes, is expected to yield topline results in August. This milestone is crucial as there are currently no FDA-approved treatments for this condition in the at-home setting.
Read more →BTAIBioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics (BTAI) announced that it has achieved alignment with the FDA regarding its plans for a supplemental New Drug Application (sNDA) for BXCL501, intended for outpatient treatment of agitation associated with bipolar disorders or schizophrenia. The FDA's positive comments indicate that the company is on track for a submission in the first quarter of 2026. This marks a significant milestone for BioXcel, as they aim to broaden the existing IGALMI label to include at-home use. The decision is based on feedback that confirms their submission package will likely meet regulatory conditions.
Read more →BTAI▼ -17.6%on this news· ran to -30% by day 1shared move
BioXcel Therapeutics to Participate in the H.C. Wainwright & Co. “HCW@Home” Series
BioXcel Therapeutics, Inc. announced that its CEO, Vimal Mehta, will participate in a virtual fireside chat as part of the H.C. Wainwright & Co. "HCW@Home" series on August 14, 2025. The company is focused on utilizing artificial intelligence to develop transformative medicines, particularly in the fields of neuroscience and immuno-oncology. The event signifies a strategic move to increase visibility within the biopharmaceutical industry. BioXcel's innovative approach, leveraging existing approved drugs with big data, positions it for potential advancements in therapeutic indications.
Read more →BTAI▲ +6.3%on this newsshared move
BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates Topline data from SERENITY At-Home Phase 3 trial for acute treatment of agitation associated with bipolar disorders or schizo
BioXcel Therapeutics (BTAI) reported its financial results for Q2 2025, highlighting the completion of its SERENITY At-Home Phase 3 trial for the acute treatment of agitation associated with bipolar disorders and schizophrenia. Preliminary results suggest an expanded market potential for BXCL501, which the company is optimistic about. However, the financial performance shows a notable operating loss, and IGALMI revenue has decreased significantly from the previous year. The company is actively working towards potential label expansion and further development in chronic conditions.
Read more →BTAI▲ +58.4%on this newsshared move
BioXcel Therapeutics to Participate in Canaccord Genuity 45th Annual Growth Conference
BioXcel Therapeutics, Inc. has announced its participation in the Canaccord Genuity 45th Annual Growth Conference, to be held in Boston on August 12, 2025. CEO Vimal Mehta, Ph.D., will engage in a fireside chat during the event, aiming to discuss the company’s strategies and developments in neuroscience. A live webcast of the discussion will be available, with a replay offered for 90 days. The announcement reflects the company's focus on visibility within the biopharmaceutical sector.
Read more →BTAI▲ +58.4%on this newsshared move
xAE; BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | www.bioxceltherapeutics.com August 2025 BXCL501 Commercial Opportunity in the At-Home Setting for Bipolar Disorders and Schizophrenia N
BioXcel Therapeutics has presented information concerning the commercial potential of its BXCL501 medication for treating agitation in bipolar disorder and schizophrenia. The data highlights a high degree of uncertainty linked to the company's future performance, emphasizing various risk factors. Although management believes in the reliability of third-party sources, it does not endorse their accuracy. The presentation urges caution with forward-looking statements given the potential for actual results to diverge significantly from expectations.
Read more →BTAI▲ +11.8%on this news· ran to +115% by day 3shared move
BioXcel Therapeutics Announces Publication in Frontiers in Pharmacology on the Effects of Dexmedetomidine (the active ingredient in BXCL-501) on Stress-Mediated Behaviors in Non-clinical Studies
BioXcel Therapeutics has announced the publication of a study in Frontiers in Pharmacology, highlighting the effects of dexmedetomidine in reducing stress-induced behaviors. The findings suggest potential applications of BXCL501 for treating a range of chronic psychiatric disorders, in addition to its current FDA-approved use for acute agitation. Ongoing clinical studies are exploring the efficacy of BXCL501 in various stress-related conditions. The positive results underscore its potential for broader therapeutic uses and support the drug's existing safety profile.
Read more →BTAIBioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics announced the completion of the last patient visit in the Phase 3 SERENITY At-Home clinical trial for treating agitation linked to bipolar disorders and schizophrenia. The double-blind, placebo-controlled study evaluated the safety of BXCL501 in a home setting and successfully enrolled over 200 patients across 22 sites. Topline data from the trial is expected to be released this month, which aims to support a supplemental New Drug Application for expanding IGALMI's label for at-home use.
Read more →BTAIBioXcel Therapeutics Submits Pre-Supplemental New Drug Application Meeting Package in Support of Potential Label Expansion for IGALMI
BioXcel Therapeutics has submitted a pre-supplemental New Drug Application meeting package to the FDA for IGALMI, aimed at obtaining approval for its outpatient use in treating agitation associated with bipolar disorders and schizophrenia. A meeting with the FDA is scheduled for August 20, 2025, to ensure alignment on the planned sNDA submission. The company is nearing completion of the SERENITY At-Home Phase 3 trial, which evaluates the outpatient use of IGALMI, and expects to report top-line results soon.
Read more →BTAI▲ +8.8%on this news
BioXcel Therapeutics Receives Second Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics has received a second positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue its SERENITY At-Home pivotal Phase 3 safety trial for BXCL501. This trial focuses on the acute treatment of agitation associated with bipolar disorders or schizophrenia in a home setting. The DSMB's recommendation was based on the review of safety data from 178 patients as of May 28, 2025, with topline data expected in Q3 2025. The trial aims to evaluate the safety of BXCL501, a proprietary formulation, in addressing a significant unmet medical need.
Read more →BTAIBioXcel Therapeutics Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) to Continue SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) has recommended the continuation of its SERENITY At-Home pivotal Phase 3 safety trial for BXCL501, aimed at treating agitation associated with bipolar disorders or schizophrenia. This recommendation followed a review of safety data from the initial 115 patients dosed. The trial is fully enrolled with over 205 patients and aims to collect data for a 12-week period. Topline data is expected to be released in Q3 2025.
Read more →BTAIBioXcel Therapeutics Granted Extension to Regain Compliance with Nasdaq Continued Listing Requirement
BioXcel Therapeutics has received an extension from the Nasdaq Hearings Panel to continue its listing on the Nasdaq Stock Market, allowing until September 16, 2025, to regain compliance with the required market value of listed securities. The panel reviewed the company's strategies to achieve compliance during a hearing on May 1, 2025. BioXcel's CEO expressed confidence in the company's initiatives, including a key Phase 3 trial related to its product BXCL501, aimed at treating agitation in patients. However, the company must meet certain conditions to maintain its listing.
Read more →BTAIBioXcel Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update Enrollment complete in SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar
BioXcel Therapeutics has completed enrollment in its SERENITY At-Home pivotal Phase 3 trial for the treatment of agitation associated with bipolar disorders. The trial aims to evaluate the safety of BXCL501, with data expected in the second half of 2025 to support a potential sNDA submission for IGALMI. Financial results for Q1 2025 showed a decreased net loss and reduced expenses compared to the same period in the previous year, though sales figures raised concerns about commercial viability.
Read more →BTAI▲ +6%on this news
BioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2024 Enrollment exceeds 60% of required number of patients in SERENITY At-Home pivotal Phase 3 safety trial evaluating 200 patients for
BioXcel Therapeutics reported its financial results for Q4 and the full year 2024, with significant progress in enrolling patients for its SERENITY At-Home Phase 3 trial. More than 60% of the required patients have enrolled, and topline data is anticipated in the latter half of 2025. The company also reported a strengthened cash position to advance its lead asset, BXCL501. However, despite increased revenues from IGALMI, BioXcel experienced a substantial net loss for the year.
Read more →BTAI▼ -16.8%on this news· ran to -28% by day 3
BioXcel Therapeutics Strengthens Cash Position to Advance SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics has enhanced its cash reserves to $35 million after a $14 million equity financing, facilitating the continuation of its SERENITY At-Home Phase 3 trial. This trial investigates the safety of BXCL501 for managing agitation in individuals with bipolar disorders or schizophrenia at home. The company anticipates releasing topline data in the second half of 2025, which could support a supplemental New Drug Application for expanding the drug's label for at-home use. While the development represents progress in treatment options, safety concerns regarding IGALMI remain prominent.
Read more →BTAI▲ +23%on this newsshared move
BioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics has announced that it has reached 33% enrollment in its 200-patient SERENITY At-Home Phase 3 trial, which evaluates the safety of BXCL501 for the treatment of agitation linked to bipolar disorders and schizophrenia. The trial aims to support a supplemental new drug application for label expansion of IGALMI in home settings. Approximately 23 clinical trial sites are actively enrolling patients, and topline data results are anticipated in the second half of 2025.
Read more →BTAI▼ -28%on this newsshared move
BioXcel Therapeutics Announces Closing of $14 Million Registered Direct Offering
BioXcel Therapeutics, Inc. announced the successful closure of a $14 million registered direct offering, involving the sale of 4 million shares of common stock and accompanying warrants. The shares were sold at a price of $3.50 each, with warrants priced at $4.20 per share, exercisable for five years. This funding is intended to support the company's ongoing efforts in developing transformative medicines through artificial intelligence. The offering was completed on March 4, 2025, with Rodman & Renshaw LLC serving as the placement agent.
Read more →BTAI▲ +73.6%on this newsshared move
BioXcel Therapeutics Announces FDA Closed its Inspection of Site for Phase 3 TRANQUILITY II Trial for Acute Treatment of Agitation Associated with Alzheimer’s Dementia
BioXcel Therapeutics has announced that the FDA has closed its inspection of a site involved in the Phase 3 TRANQUILITY II trial for BXCL501, a treatment for agitation associated with Alzheimer's dementia. The FDA's designation of 'Voluntary Action Indicated' suggests no significant issues were found. The company believes that this closure, along with favorable audit results, reinforces the reliability of their trial data. BioXcel is currently preparing for a potential submission of a supplemental New Drug Application (sNDA) based on these findings.
Read more →BTAI▲ +73.6%on this newsshared move
BioXcel Therapeutics Announces $14 Million Registered Direct Offering
BioXcel Therapeutics has announced a registered direct offering to raise approximately $14 million through the sale of 4 million shares at $3.50 each, along with accompanying warrants. The offering is expected to close on March 4, 2025, pending customary closing conditions. The company plans to utilize the proceeds for working capital and general corporate purposes. Additionally, an option for purchasers to buy up to another 4 million shares is available.
Read more →BTAI▲ +24.9%on this news· ran to +117% by day 1shared move
BioXcel Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Rule
BioXcel Therapeutics has announced that it has regained compliance with Nasdaq's minimum bid price rule after previously failing to maintain the required closing bid price of $1.00 per share. The company successfully met the requirement by maintaining this price for 12 consecutive trading days as of February 26, 2025. This demonstrates the company's recovery in stock performance and its ongoing commitment to utilizing artificial intelligence in drug development.
Read more →BTAI▼ -37.6%on this news
BioXcel Therapeutics Announces Reverse Stock Split
BioXcel Therapeutics has announced a 1-for-16 reverse stock split of its common stock, effective February 7, 2025. This action aims to help the company comply with the Nasdaq minimum bid price requirement. All stockholders will be treated uniformly in this split, but fractional shares will be converted into cash payments. The decision was confirmed by stockholders during a special meeting held on January 28, 2025, and is part of a broader strategic vision for the company's future amidst financial uncertainty.
Read more →BTAIBioXcel Therapeutics Provides Clinical and Business Update
BioXcel Therapeutics recently updated on its progress with BXCL501, focusing on the SERENITY and TRANQUILITY trials aimed at treating agitation in bipolar disorders, schizophrenia, and Alzheimer's dementia. The company is advancing patient enrollment in the SERENITY At-Home Phase 3 trial and has plans for the TRANQUILITY In-Care trial. Additionally, BioXcel has strengthened its operational capabilities through a credit amendment and raised $7 million in funding. Recent appointments to the Board of Directors bring significant clinical and financial expertise to the company.
Read more →BTAI▼ -10.8%on this news
BioXcel Therapeutics Announces Pricing of $7.0 Million Public Offering
BioXcel Therapeutics, Inc. has announced the pricing of a public offering for 5,600,000 shares of its common stock and accompanying warrants, aiming to raise approximately $7.0 million. The offering, priced at $0.48 per share, is expected to close on or around November 25, 2024, subject to customary conditions. Canaccord Genuity is acting as the sole book-running manager for the offering, which is conducted under a previously filed shelf registration statement with the SEC.
Read more →BTAIBioXcel Therapeutics Announces Proposed Public Offering
BioXcel Therapeutics has announced a proposed public offering of its common stock and accompanying warrants. The funds generated from this offering will be utilized to support the SERENITY At-Home trial and to prepare for the upcoming TRANQUILITY In-Care trial, alongside working capital and general corporate purposes. Canaccord Genuity is serving as the sole book-running manager for the offering, yet its completion is contingent upon market conditions.
Read more →BTAI▼ -15.9%on this news
BioXcel Therapeutics Reports Third Quarter 2024 Financial Results Advancing two pivotal Phase 3 trials of BXCL501 for acute treatment of agitation associated with bipolar disorders, schizophrenia, and Alzheimer's dementi
BioXcel Therapeutics, Inc. reported its financial results for the third quarter of 2024, highlighting advancements in two pivotal Phase 3 trials for BXCL501 targeting agitation in bipolar disorders, schizophrenia, and Alzheimer's dementia. The company noted a 89% increase in net revenue year-over-year, despite reporting a net loss of $13.7 million for the quarter. Management emphasized the ongoing commitment to clinical trials and market expansion opportunities, although challenges in revenue from existing products were apparent.
Read more →BTAI▼ -7.6%on this news· ran to -21% by day 3shared move
BioXcel Therapeutics Advances Pivotal Phase 3 Trials of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders, Schizophrenia, and Alzheimer’s Dementia
BioXcel Therapeutics has made significant strides in its Phase 3 clinical trials for BXCL501, targeting acute treatment of agitation in patients with bipolar disorders, schizophrenia, and Alzheimer's dementia. The company has randomized its first patient in the SERENITY At-Home trial and received FDA feedback for the TRANQUILITY In-Care trial. These developments aim to address a critical unmet medical need, as no FDA-approved acute therapies currently exist for these conditions. The trials are designed to evaluate the safety and efficacy of BXCL501 in respective patient populations.
Read more →BTAIBioXcel Therapeutics to Report Third Quarter 2024 Financial Results on November 14, 2024
BioXcel Therapeutics, Inc. announced plans to report its third quarter 2024 financial results on November 14, 2024. The financial results will be released before the U.S. market opens, followed by a conference call at 8:00 AM ET to discuss these outcomes and provide a business update. The company, which focuses on utilizing artificial intelligence for drug development in neuroscience, emphasizes its innovative approach in the biopharmaceutical sector.
Read more →BTAI▲ +6.6%on this news
BioXcel Therapeutics to Present at ThinkEquity Conference
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is scheduled to present at the ThinkEquity Conference in New York City on October 30 at 2 p.m. ET. The presentation will be delivered by Vimal Mehta, Ph.D., CEO, and Vincent J. O’Neill, M.D., Executive Vice President. The company focuses on the application of artificial intelligence in developing medicines, specifically in neuroscience and immuno-oncology. Investors can access a live webcast of the presentation on the company's website.
Read more →BTAI▲ +6.1%on this news
BioXcel Therapeutics Announces U.S. Department of Defense Grant to University of North Carolina to Fund Study of BXCL501 (Sublingual Dexmedetomidine) for Treating Acute Stress Disorder
BioXcel Therapeutics has announced a partnership with the University of North Carolina, receiving a $2.8 million grant from the U.S. Department of Defense. This funding will support a study to assess the efficacy and safety of BXCL501 in treating acute stress disorder (ASD). The double-blind, placebo-controlled trial is set to enroll 100 patients starting in the first half of 2025, with the objective of reducing ASD symptoms and preventing long-term post-traumatic effects. BXCL501 is positioned as a potential intervention for urgent mental health needs following trauma.
Read more →BTAIBioXcel Therapeutics Announces Clinical Prioritization and Update on BXCL501 Late-Stage Programs for Agitation
BioXcel Therapeutics has announced a clinical prioritization of its late-stage development programs for BXCL501, focusing on the treatment of agitation in conditions such as bipolar disorder, schizophrenia, and Alzheimer's dementia. The company initiated the SERENITY At-Home pivotal Phase 3 trial and submitted a protocol for the TRANQUILITY In-Care trial. Despite these advancements, BioXcel plans to maintain its drug IGALMI in the market without active commercial support, indicating a shift in resource allocation. The success of these trials may provide growth opportunities, although there are risks regarding the lack of assurance for regulatory approval.
Read more →BTAIBioXcel Therapeutics Announces Initiation of SERENITY At-Home Pivotal Phase 3 Safety Trial of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics has initiated patient enrollment in the SERENITY At-Home pivotal Phase 3 trial for BXCL501, aimed at evaluating its safety for treating agitation linked to bipolar disorders or schizophrenia in a home setting. This trial is significant as there are currently no FDA-approved therapies for such conditions in the at-home context. The trial will engage about 200 patients and will collect safety data throughout a 12-week period. BXCL501 is a proprietary formulation of dexmedetomidine and has received Breakthrough and Fast Track designations from the FDA for its investigational uses.
Read more →BTAI▼ -5.1%on this news· ran to -32% by day 3
BioXcel Therapeutics to Participate in Canaccord Genuity 44th Annual Growth Conference
BioXcel Therapeutics, Inc. will participate in the Canaccord Genuity 44th Annual Growth Conference in Boston on August 13, 2024. CEO Vimal Mehta and Dr. Vincent J. O'Neill will engage in a fireside chat, discussing the company's focus on AI-driven medicines in neuroscience and immuno-oncology. A live webcast of the event will be available on BioXcel's website, with a replay accessible for 90 days. The company emphasizes its innovative approach to drug development through the use of AI and big data.
Read more →BTAIBioXcel Therapeutics Reports Second Quarter 2024 Financial Results Planning initiation of SERENITY At-Home pivotal Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophre
BioXcel Therapeutics announced its financial results for Q2 2024, highlighting a 141% increase in revenue compared to Q2 2023, driven by growth in contracting with psychiatric care clinics. The company is preparing to initiate two pivotal Phase 3 trials for its treatment BXCL501, targeting acute agitation in bipolar disorder and schizophrenia. Despite reporting a net loss of $8.3 million, a significant reduction from the previous year's loss, management remains optimistic about its strategic priorities and the potential of its product pipeline.
Read more →BTAI▼ -6.8%on this news
BioXcel Therapeutics to Report Second Quarter 2024 Financial Results on August 6, 2024
BioXcel Therapeutics, Inc. will release its second quarter 2024 financial results on August 6, 2024, prior to the opening of U.S. markets. The company, which utilizes artificial intelligence for drug development in neuroscience and immuno-oncology, will also host a conference call that same day at 8:00 AM ET to discuss the financial results and provide a business update. This event demonstrates the firm's ongoing commitment to transparency with investors.
Read more →BTAI▲ +9.8%on this news
BioXcel Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales of IGALMI (dexmedetomidine) Sublingual Film Focused market-access strategy generates estimated net revenue of approxim
BioXcel Therapeutics announced preliminary unaudited net revenues of approximately $1.1 million for the sales of IGALMI (dexmedetomidine) sublingual film in Q2 2024. This figure represents a 90% increase from the prior quarter and a 141% increase compared to the same period in the previous year, driven by enhanced contracting with psychiatric care clinics. CEO Vimal Mehta expressed optimism regarding IGALMI's acceptance in treating agitation associated with schizophrenia and bipolar disorders. The company is also working on expanding IGALMI's market presence into the at-home setting if the ongoing development of BXCL501 proves successful.
Read more →BTAIBioXcel Therapeutics Announces Positive Topline Results from Post-Marketing Requirement Study Evaluating PRN Treatment of IGALMI™ (dexmedetomidine) Sublingual Film for Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics announced positive topline results from a post-marketing requirement study for IGALMI™ (dexmedetomidine) sublingual film, which showed no evidence of tachyphylaxis, tolerance, or withdrawal at the highest approved dose. The study involved 28 inpatients experiencing agitation associated with bipolar disorders or schizophrenia, and results indicated a noticeable reduction in agitation symptoms. The findings support the company's ongoing Phase 3 SERENITY and TRANQUILITY programs, setting a positive outlook for future developments. No serious adverse events were reported during the study, highlighting the treatment's safety and tolerability.
Read more →BTAIBioXcel Therapeutics to Present at Jefferies Global Healthcare Conference
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) has announced the participation of CEO Vimal Mehta at the Jefferies Global Healthcare Conference on June 5, 2024. The presentation will focus on late-stage clinical programs involving BXCL501, an investigational treatment for agitation linked to various mental health conditions. While the drug has received Breakthrough Therapy designation, its safety and efficacy for these uses remain unproven, raising some concerns. The event aims to enhance investor interest and provide updates on the company's ongoing development efforts.
Read more →BTAIBioXcel Therapeutics Announces Oral and Poster Presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
BioXcel Therapeutics announced that it will present its research at the 2024 ASCP Annual Meeting in Miami Beach, focusing on its investigational agent BXCL501. The presentations include an oral discussion on the comparison of BXCL501 with Quetiapine, as well as various poster presentations on the drug's use in treating agitation associated with dementia and bipolar disorders. BXCL501 has received several designations from the FDA, indicating its potential as a new treatment for agitation in certain conditions. The meeting will be held from May 28 to 31, 2024.
Read more →BTAI▲ +8.7%on this news
BioXcel Therapeutics Reports First Quarter 2024 Financial Results Advancing TRANQUILITY and SERENITY program plans for two pivotal Phase 3 trials to expand BXCL501 market potential in acute treatment of agitation Strengt
BioXcel Therapeutics has reported its financial results for the first quarter of 2024, highlighting advancements in its TRANQUILITY and SERENITY programs aimed at facilitating pivotal Phase 3 trials for BXCL501. The company experienced a notable 182% increase in revenue from IGALMI, suggesting growing demand for its products. Additionally, BioXcel has strengthened its intellectual property portfolio with the granting of two new patents. However, the company continues to face a net loss, which, while reduced compared to last year, still raised concerns about its financial health.
Read more →BTAIBioXcel Therapeutics to Report First Quarter 2024 Financial Results on May 9, 2024
BioXcel Therapeutics, Inc. announced it will publish its financial results for the first quarter of 2024 on May 9, 2024. The announcement includes details for a conference call and webcast scheduled for the same day, where the management team will discuss these results and provide a general business update. The company is known for leveraging artificial intelligence in the development of medicines in neuroscience and immuno-oncology. Investors and analysts will have access to a replay of the conference call until August 9, 2024.
Read more →BTAI▼ -8.8%on this newsshared move
BioXcel Therapeutics Announces Late-Breaking Abstract on Preliminary Findings from Phase 2 Investigator-Sponsored Trial of BXCL701 and KEYTRUDA in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Selected for Presentation at 2024 ASCO Annual Meeting
BioXcel Therapeutics has announced a late-breaking abstract regarding preliminary findings from a Phase 2 trial of BXCL701 in combination with KEYTRUDA for treating metastatic pancreatic ductal adenocarcinoma. The trial, led by Georgetown University’s Lombardi Comprehensive Cancer Center, aims to explore the efficacy of BXCL701 as an immune activator to improve treatment response. The findings will be presented during the upcoming ASCO Annual Meeting in June 2024, highlighting the drug's potential benefits in transforming the tumor environment. This trial follows the conclusion of patient enrollment in an initial safety lead-in phase.
Read more →BTAIBioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | bioxceltherapeutics.com NASDAQ: BTAI April 2024 AI - Driven Transformative Medicines in Neuroscience This presentation includes "forward - l
BioXcel Therapeutics is focusing on the development of AI-driven transformative medicines in neuroscience, particularly in treating agitation associated with conditions like Alzheimer's and bipolar disorders. The company's forward-looking statements indicate both opportunities and risks, highlighting its clinical trials for BXCL 501 and extensive regulatory obligations. Despite a promising approach with advanced-phase programs, concerns exist regarding its financial stability and commercial viability. The company must navigate significant challenges as it strives to bring its innovative therapies to market.
Read more →BTAIBioXcel Therapeutics Announces Plan for Evaluating BXCL501 in the At-Home Setting to Expand Its Market Potential
BioXcel Therapeutics is set to initiate the SERENITY At-Home Phase 3 trial to evaluate BXCL501 as a treatment for agitation related to bipolar disorders or schizophrenia. This pivotal trial will assess the safety and efficacy of the drug administered at home, where a significant volume of agitation episodes occur. Following FDA discussions, the study aims to enroll approximately 200 patients and is expected to provide crucial data to support a potential label expansion for outpatient use.
Read more →BTAIAcute Treatment of Agitation Associated with Alzheimer's Dementia (AAD) 1 TRANQUILITY Program
BioXcel Therapeutics, Inc. is advancing its TRANQUILITY program, which focuses on BXCL 501 as a potential acute treatment for agitation associated with Alzheimer's dementia. Agitation is a prevalent issue, affecting nearly 50% of Alzheimer’s patients in the U.S., with no FDA-approved treatment options currently available. The company acknowledges various risks, including limited revenue generation, the need for additional funding, and uncertainties surrounding its clinical trial outcomes. Despite these challenges, BioXcel remains optimistic about its efforts to address a significant unmet medical need.
Read more →BTAIBioXcel Therapeutics Announces TRANQUILITY In-Care Pivotal Phase 3 Trial Plan With BXCL501 for Agitation Associated With Alzheimer’s Dementia
BioXcel Therapeutics has announced its plan to initiate the TRANQUILITY In-Care Phase 3 trial for BXCL501, targeting agitation associated with Alzheimer's dementia. This decision follows positive feedback from the FDA, indicating that there are currently no approved treatments for this condition in the acute setting. The trial will enroll around 150 patients across various levels of dementia severity, testing the efficacy of a 60 mcg dose of BXCL501 over a 12-week period. Key endpoints will include assessing changes in agitation levels through validated scales.
Read more →BTAIBioXcel Therapeutics Announces $25 Million Registered Direct Offering
BioXcel Therapeutics, Inc. announced a registered direct offering consisting of over 3 million shares of common stock and accompanying warrants, aiming to raise about $25 million. The offering is set to close on March 27, 2024, pending standard closing conditions. Notably, there are no underwriting fees involved, allowing the company to retain more capital. The initiative marks a strategic move to bolster its financial resources.
Read more →BTAI▼ -6.6%on this news
BioXcel Therapeutics Announces European Patent Office’s Grant of Patent for Method of Treating Agitation in Dementia Using Sublingual Dexmedetomidine
BioXcel Therapeutics has received a European patent for its method of using sublingual dexmedetomidine to treat agitation in dementia, enhancing its intellectual property portfolio. The newly granted Patent No. 3,562,486 covers various dosage forms of dexmedetomidine, including films, wafers, and tablets. This patent, along with recent approvals in the US, positions BioXcel to expand the commercialization of its product BXCL501 across major markets, establishing a robust framework for future growth in treating agitation in neuropsychiatric disorders.
Read more →BTAIBioXcel Therapeutics Reports Financial Results for the Fourth Quarter and Full Year 2023 Provides update on two late-stage clinical programs for BXCL501 for potential treatment of agitation Recently completed meetings wi
BioXcel Therapeutics, Inc. reported its financial results for Q4 and full year 2023, highlighting the advancement of its late-stage clinical programs for BXCL501 aimed at treating agitation. The company experienced growth in net revenue from IGALMI, with $1.4 million reported for the full year. However, a net loss of $22.3 million for Q4 emphasizes ongoing financial challenges. The company continues to focus on its high-priority TRANQUILITY and SERENITY programs while managing operational expenses due to a decrease in clinical trial activity.
Read more →BTAIBioXcel Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results on March 12, 2024
BioXcel Therapeutics will announce its fourth quarter and full year 2023 financial results on March 12, 2024, prior to the U.S. market opening. A conference call and webcast will take place at 8:00 AM ET to discuss the results and provide a business update. The company uses artificial intelligence to develop medicines in neuroscience and immuno-oncology, demonstrating its commitment to innovation in the pharmaceutical sector.
Read more →BTAI▲ +26%on this news· ran to +46% by day 1
BioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | bioxceltherapeutics.com NASDAQ: BTAI February 2024 AI - Driven Transformative Medicines in Neuroscience This presentation includes "forward
BioXcel Therapeutics is advancing its AI-driven medicines for neuropsychiatric disorders, including agitation associated with Alzheimer's dementia. The company has reported significant potential market opportunities and highlighted progress in its clinical trials, specifically for candidates BXCL501 and BXCL701. However, it faces challenges such as funding needs, trial enrollment difficulties, and uncertainties regarding regulatory approvals. The firm emphasizes its unique business model and rapid drug development process as factors for long-term growth potential.
Read more →BTAI▲ +26.2%on this news· ran to +80% by day 3shared move
BioXcel Therapeutics Announces Termination of Proposed Public Offering
BioXcel Therapeutics has announced the termination of its previously proposed public offering of $60 million in shares. The decision was made following an assessment from management that current market conditions do not support favorable terms for stockholders. Instead, the company plans to focus on their upcoming FDA meeting set for February 20, 2024, regarding their Phase 3 TRANQUILITY At Home trial for BXCL501, aimed at treating agitation associated with dementia. Trial data is expected to be released in Q1 2025.
Read more →BTAI▼ -7.6%on this news· ran to +70% by day 3shared move
BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL701 for Treatment of Small Cell Neuroendocrine Prostate Cancer (SCNC)
BioXcel Therapeutics has received FDA Fast Track designation for BXCL701, an investigational therapy for patients with metastatic small cell neuroendocrine prostate cancer (SCNC). This designation will facilitate expedited review and development, allowing more frequent interaction with the FDA. The drug aims to inflame the tumor microenvironment to enhance the efficacy of checkpoint inhibitors. BXCL701 has shown promising results in early clinical trials and targets a currently underserved patient population with limited treatment options.
Read more →BTAI▼ -7.6%on this news· ran to +70% by day 3shared move
BIOXCEL ALERT: Bragar Eagel & Squire, P.C. is Investigating BioXcel Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
Bragar Eagel & Squire, P.C. is investigating BioXcel Therapeutics, Inc. on behalf of long-term stockholders after a class action complaint was filed due to alleged breaches of fiduciary duties. The investigation stems from serious issues related to the company's Phase 3 TRANQUILITY II clinical trial for BXCL501, where the principal investigator failed to follow proper guidelines. This included failures in informed consent and maintaining patient records, as well as allegations of fabricated correspondence provided to the FDA. Consequently, BioXcel's stock suffered a significant decline of 63.8% after these disclosures, raising concerns about the company's regulatory approval prospects.
Read more →BTAI▲ +8.9%on this news· ran to -43% by day 3shared move
BioXcel Therapeutics Announces Completion of Patient Enrollment in Safety Portion of Investigator-Sponsored Phase 2 Relapsed Pancreatic Cancer Trial of BXCL701 in Combination with KEYTRUDA
BioXcel Therapeutics announced the completion of patient enrollment in the safety portion of a Phase 2 trial assessing the safety of BXCL701 in combination with KEYTRUDA for relapsed pancreatic cancer. The trial aims to evaluate the drug's effectiveness following promising preclinical results. With pancreatic cancer being a challenging disease with a five-year survival rate of only 13%, the trial signifies a crucial step towards addressing this unmet medical need. Initial safety assessment will be followed by a larger efficacy phase expected to commence in early 2024.
Read more →BTAI▲ +21.2%on this news· ran to +32% by day 1shared move
BioXcel Therapeutics Announces USPTO’s Allowance of Patent Application for Method of Treating Agitation in Alzheimer’s Disease Using Oromucosal Formulations of Dexmedetomidine
BioXcel Therapeutics has announced that the USPTO has allowed a patent application concerning the treatment of agitation in Alzheimer's disease using dexmedetomidine. This new patent, along with an additional method of use patent for agitation associated with schizophrenia and bipolar disorder, bolsters the company's IP portfolio and market exclusivity for its product IGALMI. The protections are expected to extend into the 2040s, significantly enhancing BioXcel's potential market opportunities for these treatments.
Read more →BTAIBioXcel Therapeutics Hosting Virtual Neuroscience R&D Day Today
BioXcel Therapeutics is hosting a virtual Neuroscience R&D Day today, focusing on its pipeline candidates, including BXCL502, which is aimed at treating agitation in Alzheimer's patients. During the event, notable neuropsychiatry experts will discuss the potential of BXCL502 and BXCL501 for addressing various neuropsychiatric conditions. The event emphasizes the company's reliance on artificial intelligence for developing transformative medicines in the field.
Read more →BTAIBioXcel Therapeutics Strengthens Clinical Development Leadership to Advance Late-Stage Programs
BioXcel Therapeutics has announced the promotion of Vincent J. O'Neill to Executive Vice President and Chief of Product Development, as well as the appointment of Rajiv Patni as Strategic Clinical Advisor. This strategic move aims to prioritize the advancement of late-stage clinical programs, particularly focusing on the efficacy of BXCL501 for treating agitation related to Alzheimer's, bipolar disorder, and schizophrenia. The company is leveraging its AI capabilities to fuel further development of innovative candidates while addressing important market opportunities. Both executives bring extensive experience to the leadership team, anticipating a significant impact on BioXcel's operations in the upcoming year.
Read more →BTAIBioXcel Therapeutics to Host Virtual Neuroscience R&D Day on Dec. 12, 2023
BioXcel Therapeutics, Inc. is set to host a virtual Neuroscience R&D Day on December 12, 2023, where it will present its R&D strategy and discuss the development programs for its investigational treatments BXCL502 and BXCL501. The event will feature notable neuropsychiatry experts addressing topics such as agitation relief in Alzheimer's disease and opioid withdrawal management. The company's unique AI-driven approach aims to uncover new treatment candidates, reinforcing its commitment to advancing neuroscience therapeutics.
Read more →BTAI▼ -23.4%on this news
BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing, and Reports Third Quarter 2023 Financial Results Company plans to conduct Phase 3 tri
BioXcel Therapeutics announced alignment with FDA recommendations to conduct a Phase 3 trial for its TRANQUILITY program, focusing on BXCL501's at-home treatment for agitation in Alzheimer's patients. The company also updated its strategic financing arrangements with Oaktree Capital and Qatar Investment Authority to enhance operational flexibility. For the third quarter of 2023, BioXcel reported a net revenue of approximately $341,000 but faced a significant net loss of $50.5 million. The company aims to improve its financial position while advancing its clinical programs in neuroscience.
Read more →BTAIBioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) of Adenocarcinoma Phenotype
BioXcel Therapeutics has reported encouraging overall survival results from its Phase 2 trial of BXCL701 combined with KEYTRUDA in patients with metastatic castration-resistant prostate cancer. Results indicate a median overall survival of 15.5 months, significantly higher than traditional treatment options. Additionally, the trial showed a one-year survival rate of 59%. The company is planning to discuss the future development of BXCL701 with the FDA in December, raising hope for further advancements in treatment options for these patients.
Read more →BTAIBioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)
BioXcel Therapeutics has provided an update on its ongoing NIDA-funded trial evaluating BXCL501 as a potential treatment for opioid use disorder. The trial, led by Columbia University, is expected to add a fourth site to enhance patient recruitment, aiming for completion in 2024. BXCL501, a sublingual formulation of dexmedetomidine, has shown promise in alleviating withdrawal symptoms associated with fentanyl exposure. The company plans to seek FDA input on potential pathways for registration after the trial's completion.
Read more →BTAIBioXcel Therapeutics to Report Third Quarter 2023 Financial Results on November 14, 2023
BioXcel Therapeutics, Inc. announced that it will release its third quarter financial results on November 14, 2023, before the U.S. market opens. The company plans to host a conference call at 8:00 AM ET to discuss these results along with a general business update. BioXcel focuses on using artificial intelligence to develop innovative medicines in the field of neuroscience.
Read more →BTAI▲ +31.7%on this newsshared move
BioXcel Therapeutics Receives Permanent J-Code for IGALMI™ (dexmedetomidine) Sublingual Film from Centers for Medicare & Medicaid Services
BioXcel Therapeutics has announced the receipt of a permanent J-Code, J1105, for its product IGALMI™ (dexmedetomidine) sublingual film, effective January 1, 2024. This permanent coding will simplify the reimbursement process under the Healthcare Common Procedure Coding System (HCPCS), which is anticipated to improve product utilization and patient access to treatment for agitation linked to schizophrenia and bipolar disorders. This move is expected to remove economic barriers and facilitate formulary approval decisions.
Read more →BTAI▲ +20.9%on this news· ran to +71% by day 3shared move
BioXcel Therapeutics Announces Positive Findings from Independent Third Party Audit of Data Integrity at TRANQUILITY II Phase 3 Trial Site
BioXcel Therapeutics announced that an independent audit of the TRANQUILITY II Phase 3 trial data found no evidence of misconduct or fraud. The audit reviewed over 50% of the subjects at the trial site and confirmed the integrity of the data, reinforcing the company's confidence in their positive trial results. As a result, BioXcel plans to proceed with a supplemental new drug application for BXCL501 to treat agitation associated with dementia in probable Alzheimer's disease.
Read more →BTAI▲ +21.5%on this news
BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Small Cell Neuroendocrine Prostate Cancer Median overall survival of 13.6 months with B
BioXcel Therapeutics announced encouraging results from its Phase 2 trial of BXCL701 combined with KEYTRUDA in patients with small cell neuroendocrine prostate cancer. The trial showcased a median overall survival of 13.6 months, with 56% of patients alive after one year. This outcome contrasts significantly with the historical results of checkpoint inhibitor monotherapy. The company’s findings suggest potential for BXCL701 to help a growing patient population facing a high unmet medical need, and they intend to discuss these results with the FDA for future clinical development.
Read more →BTAI▲ +13.2%on this news
BioXcel Therapeutics Provides Update on Recent Developments for Late-Stage Clinical Programs and Expansion of IP Portfolio for IGALMI™ (dexmedetomidine) Sublingual Film
BioXcel Therapeutics has announced significant updates regarding its clinical programs for BXCL501, including important upcoming meetings with the FDA to discuss the TRANQUILITY and SERENITY III trials. The company has received two Notices of Allowance which will strengthen its market exclusivity for IGALMI™, a treatment for agitation associated with psychiatric disorders. Clinical trials leading up to these developments show promising safety and efficacy results; however, the company is also addressing protocol adherence issues at one trial site. This comprehensive approach aims to expand treatment access and thorough data evaluation in underserved patient populations.
Read more →BTAIBIOXCEL SHAREHOLDER ALERT: CLAIMSFILER REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against BioXcel Therapeutics, Inc. - BTAI
BioXcel Therapeutics, Inc. is facing a securities class action lawsuit for failing to disclose critical information about its clinical trials. The lawsuit stems from allegations that the company and certain executives violated federal securities laws during a specified class period. Key concerns include FDA inspections revealing compliance issues in clinical trials and potential data fabrication by a principal investigator, which led to a significant drop in the company's stock price. Investors must file lead plaintiff applications by September 5, 2023, to recover losses.
Read more →BTAIBIOXCEL THERAPEUTICS, INC. (NASDAQ: BTAI) SHAREHOLDER ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is facing a securities class action lawsuit filed by Bernstein Liebhard LLP, targeting investors who acquired shares between December 15, 2021, and June 28, 2023. The lawsuit alleges that the company and certain officers misled investors regarding adherence to regulatory protocols and data integrity in clinical trials. A significant drop in stock price occurred after the company disclosed deficiencies in its internal controls and compliance. Investors are reminded of the deadline, September 5, 2023, to file a lead plaintiff motion in this case.
Read more →BTAIBIOXCEL SHAREHOLDER ALERT BY FORMER LOUISIANA ATTORNEY GENERAL: KAHN SWICK & FOTI, LLC REMINDS INVESTORS WITH LOSSES IN EXCESS OF $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against BioXcel Therapeutics, Inc. - BTAI
Kahn Swick & Foti, LLC announced that investors who suffered losses exceeding $100,000 in BioXcel Therapeutics, Inc. (BTAI) have until September 5, 2023, to file lead plaintiff applications in a class action lawsuit regarding alleged securities law violations. The company has been accused of failing to disclose critical information during a class period from December 2021 to June 2023. Following disclosures related to inspectional observations from the FDA, BioXcel's shares fell dramatically by 63.8%. As a result, the lawsuit could significantly impact the company’s standing and investor recovery options.
Read more →BTAIBIOXCEL THERAPEUTICS, INC. (NASDAQ: BTAI) DEADLINE ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is facing a securities class action lawsuit due to alleged misleading statements made by the company and certain officers during the Class Period from December 15, 2021, to June 28, 2023. The lawsuit claims that BioXcel failed to disclose serious issues related to data integrity and internal controls, which adversely affected its clinical trials. Following the disclosure of these allegations, BioXcel's stock price collapsed by approximately 63.8%. Investors who wish to participate must file a lead plaintiff motion by September 5, 2023.
Read more →BTAI▼ -8.3%on this newsshared move
BioXcel Therapeutics, Inc: Please contact the Portnoy Law Firm to recover your losses; September 5, 2023 deadline.
BioXcel Therapeutics, Inc. (BTAI) is facing a class action lawsuit for allegedly making materially false statements regarding its business operations from December 15, 2021, to June 28, 2023. The lawsuit highlights serious internal control deficiencies and failures related to compliance with regulatory protocols. These issues potentially impacted the company's regulatory approval prospects for BXCL501, a treatment intended for agitation in dementia patients. Investors interested in recovering their losses are encouraged to contact the Portnoy Law Firm for legal assistance.
Read more →BTAI▼ -41.5%on this newsshared move
BioXcel Therapeutics, Inc Investors: Please contact the Portnoy Law Firm to recover your losses; September 5, 2023 deadline
The Portnoy Law Firm has announced a class action lawsuit against BioXcel Therapeutics, Inc. (BTAI) on behalf of investors who purchased securities between December 15, 2021, and June 28, 2023. The lawsuit alleges that the company made materially false statements and withheld critical information about its business operations and regulatory compliance. Specific failures include inadequate internal controls and misleading communications submitted to the FDA. Investors are encouraged to contact the firm for legal evaluations and potential recovery of losses due to these alleged misrepresentations.
Read more →BTAI▼ -41.5%on this newsshared move
BioXcel Therapeutics Reports Second Quarter 2023 Financial Results and Announces Strategic Reprioritization Business to prioritize high-potential agitation market opportunities for BXCL501 in bipolar disorders, schizophr
BioXcel Therapeutics announced its Q2 2023 financial results and a strategic reprioritization to focus on high-potential market opportunities for BXCL501, particularly in treating agitation in Alzheimer's and bipolar disorder. The company intends to cut expenses by 80% and reduce its workforce to streamline operations. Despite significant revenue growth from its IGALMI product, it reported a net loss of $53.5 million in the quarter. The company is also engaging with the FDA regarding its potential new drug application for BXCL501.
Read more →BTAIBIOXCEL THERAPEUTICS, INC. INVESTOR ALERT: Kaplan Fox & Kilsheimer LLP Notifies BTAI Investors of a Class Action Lawsuit and Upcoming Deadline
BioXcel Therapeutics, Inc. is facing a class action lawsuit due to serious allegations regarding data integrity issues from a principal investigator in its Phase 3 TRANQUILITY II clinical trial. Following the discovery of these issues, including potential fabrication of documents, BioXcel's stock experienced a significant decline of 63.8%. The company is currently conducting an internal investigation and has engaged a third party to audit the data collected. This development may adversely impact BioXcel's regulatory approval processes for its treatment targeting agitation associated with Alzheimer’s disease.
Read more →BTAIBioXcel Therapeutics, Inc. Class Action Notice: Kessler Topaz Meltzer & Check, LLP Reminds BioXcel Therapeutics, Inc. (BTAI) Shareholders of Securities Fraud Class Action Lawsuit and Encourages Investors with Substantial Losses to Contact the Firm
BioXcel Therapeutics, Inc. is currently embroiled in a class action lawsuit filed in the U.S. District Court for Connecticut, accusing the company of securities fraud. The allegations stem from violations of federal securities laws, particularly regarding misleading statements about its business operations and clinical trial results. Following the disclosure of serious data integrity issues in its TRANQUILITY II clinical trial, BioXcel's stock price plummeted by 63.8%. The company is under investigation, and this situation may adversely affect its prospects for regulatory approval of BXCL501 in treating agitation in Alzheimer’s patients.
Read more →BTAIBioXcel Therapeutics to Report Second Quarter 2023 Financial Results on August 14, 2023
BioXcel Therapeutics, Inc. announced that it will release its second quarter 2023 financial results on August 14, 2023, before the U.S. financial markets open. The company will also hold a conference call and webcast at 8:00 AM ET to discuss the financial results and provide a business update. As a biopharmaceutical company focusing on developing transformative medicines using AI, BioXcel's innovative approaches continue to draw investor interest.
Read more →BTAIBioXcel Therapeutics, Inc. Investors: Contact Robbins LLP if You Incurred Significant Losses in BTAI
BioXcel Therapeutics, Inc. (BTAI) is facing a class action lawsuit filed by shareholders who allege that the company failed to disclose critical issues related to data integrity and protocol adherence during clinical trials for its drug BXCL501. These lapses included inadequate internal controls and fabricated communications to the FDA, leading to a significant drop in the company's stock price. Shareholders may file as lead plaintiffs by September 5, 2023, as the company grapples with its potential inability to secure regulatory approval for the treatment intended for agitation associated with dementia.
Read more →BTAIBioXcel Therapeutics, Inc: Please contact the Portnoy Law Firm to recover your losses; September 5, 2023 deadline
A class action lawsuit has been filed against BioXcel Therapeutics, Inc. on behalf of investors who purchased securities between December 15, 2021, and June 28, 2023. The lawsuit alleges that the company made misleading statements and failed to disclose significant negative information regarding its operations and regulatory compliance. Key issues include inadequate internal controls, non-compliance with informed consent protocols, and the inaccurate presentation of email correspondence to the FDA. These concerns could adversely affect the company's prospects, particularly in obtaining approval for BXCL501, a treatment for dementia-related agitation.
Read more →BTAI▼ -5.2%on this newsshared move
BioXcel Therapeutics, Inc. (BTAI) Sued by Shareholders: BTAI Investors Should Contact Robbins LLP for Information About Their Rights
BioXcel Therapeutics, Inc. (BTAI) has been sued by shareholders who claim the company misled investors about its internal controls and data integrity regarding clinical trials. Allegations state that the company did not comply with informed consent protocols and that fabricated evidence was presented to the FDA. Following the revelation of these issues, BTAI's stock price plummeted by over 63%. A class action has been initiated, enabling affected shareholders to seek recovery as the legal proceedings unfold.
Read more →BTAI▲ +5.2%on this newsshared move
BIOXCEL THERAPEUTICS, INC. INVESTOR ALERT: Kaplan Fox & Kilsheimer LLP Notifies BioXcel Therapeutics, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline
BioXcel Therapeutics, Inc. is facing a class-action lawsuit following significant revelations regarding its Phase 3 TRANQUILITY II clinical trial. The issues include failure to adhere to approved informed consent forms and allegations of fabricated correspondence presented to the FDA. As a result, the company's stock price fell dramatically, closing at $6.39 per share, a 63.8% drop. The ongoing investigation into these matters could affect future development plans and regulatory approvals for their medicine targeting agitation associated with Alzheimer's disease.
Read more →BTAIBioXcel Therapeutics, Inc. (BTAI) Investor Alert: Robbins LLP Reminds Investors of Class Action Against BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (BTAI) is facing a class action lawsuit filed by shareholders who purchased its securities between December 15, 2021, and June 28, 2023. The lawsuit alleges that the company failed to disclose serious lapses in data integrity and protocol adherence during its clinical trials, which could hinder the approval of its leading product, BXCL501. Following the revelation of these issues, BioXcel's stock price dropped dramatically by over 63%. Shareholders have until September 5, 2023, to file a motion to act as lead plaintiffs in the case.
Read more →BTAIBIOXCEL THERAPEUTICS, INC. SHAREHOLDER ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against BioXcel Therapeutics, Inc. (NASDAQ: BTAI)
Bernstein Liebhard LLP has announced a securities class action lawsuit against BioXcel Therapeutics, Inc. for allegedly making materially false and misleading statements throughout a specified class period. The lawsuit claims deficiencies in the company's internal controls and mismanagement regarding clinical trial protocols, which have adversely affected its product BXCL501. The stock price dropped significantly by 63.8% following disclosures of these issues, raising concerns about future regulatory approvals. Investors are encouraged to discuss their legal rights and options regarding their investments in the company.
Read more →BTAIBioXcel Therapeutics. Investors: Please contact the Portnoy Law Firm to recover your losses
The Portnoy Law Firm is investigating claims from BioXcel Therapeutics investors who have incurred financial losses. Investors are advised to contact the firm to discuss their legal rights regarding the recovery of damages under federal securities laws. The investigation highlights concerns about potential corporate wrongdoing that may have contributed to the investors’ financial losses. The firm offers complimentary case evaluations to affected investors as part of their outreach initiative.
Read more →BTAIBioXcel Therapeutics Announces Positive Topline Results From TRANQUILITY II Phase 3 Trial of BXCL501 for Acute Treatment of Alzheimer’s Disease-Related Agitation
BioXcel Therapeutics announced positive topline results from the TRANQUILITY II Phase 3 trial for BXCL501, aimed at treating Alzheimer’s disease-related agitation. The drug demonstrated a significant reduction in agitation symptoms, achieving the primary endpoint with a 39% greater reduction in PEC score compared to placebo. Safety assessments showed that BXCL501 was well tolerated, with no serious adverse events reported during the trial. The company plans to discuss potential sNDA submission with the FDA in the latter half of 2023.
Read more →BTAIBioXcel Therapeutics to Participate at Two Upcoming Investor Conferences
BioXcel Therapeutics, Inc. announced its participation in two upcoming investor conferences, with CEO Vimal Mehta and other key executives attending. The conferences are the Jefferies Global Healthcare Conference on June 8, 2023, and the Goldman Sachs Global Healthcare Conference on June 14, 2023. The events will feature presentations emphasizing the company's innovative AI-driven approach to drug development in neuroscience and immuno-oncology. Webcasts of the presentations will be available for access, reflecting the company's commitment to investor engagement.
Read more →BTAIBioXcel Therapeutics Announces Promising Topline Results from Part 1 of Pivotal SERENITY III Trial of BXCL501 for At-Home Use in Acute Treatment of Agitation in Bipolar Disorders or Schizophrenia
BioXcel Therapeutics has announced promising topline results from Part 1 of its pivotal SERENITY III trial for BXCL501, which is under investigation for the treatment of agitation in patients with bipolar disorder or schizophrenia. The trial demonstrated a greater than 50% PEC response rate, supported by favorable safety results, suggesting potential for at-home use. Although the primary efficacy endpoint was not statistically significant at the 2-hour mark, results at 4 hours indicated significant separation from placebo. BioXcel is planning to initiate Part 2 of the trial, which aims to further evaluate treatment in a home setting.
Read more →BTAIBioXcel Therapeutics Announces Positive Top-Line Data from Repeat Dosing of BXCL501 in Phase 1b Multiple Ascending Dose Trial in Healthy Volunteers for Major Depressive Disorder (MDD) Program
BioXcel Therapeutics announced positive top-line data from its Phase 1b trial of BXCL501, a sublingual film formulation for agitation and depression. The study, which involved healthy volunteers, demonstrated the safety and tolerability of BXCL501 across a dosage range without reaching maximum tolerated dose. The results support the potential for BXCL501 as an adjunctive treatment for Major Depressive Disorder alongside first-line treatments. The company plans to proceed with Phase 2 trials following these encouraging results.
Read more →BTAIBioXcel Therapeutics Reports First Quarter 2023 Financial Results and Recent Operational Highlights IGALMI (dexmedetomidine) commercial momentum accelerating with doubling of formulary wins, unlocking more than $55 milli
BioXcel Therapeutics reported its financial results for Q1 2023, showcasing commercial momentum for its product IGALMI, which doubled its formulary wins. The company unlocked over $55 million in targeted market opportunities and anticipates significant revenue growth with upcoming pivotal trial data readouts in the next few months. However, the company faced increased net losses and rising operational expenses, which may affect its financial outlook in the short term. Overall, BTAI appears to be at a critical juncture with its development pipeline and commercial strategies.
Read more →BTAIBioXcel Therapeutics to Present at the BofA Securities 2023 Health Care Conference
BioXcel Therapeutics, Inc. will be presenting at the BofA Securities 2023 Health Care Conference in Las Vegas on May 9, 2023. CEO Vimal Mehta, along with other key executives, will participate in a fireside chat, potentially enhancing the company's visibility in the biopharmaceutical sector. The company focuses on utilizing artificial intelligence in neuroscience and immuno-oncology to develop innovative treatments, including their approved medication IGALMI for treating agitation in psychiatric conditions. Their ongoing projects aim to expand therapeutic indications through advanced data analysis and machine learning algorithms.
Read more →BTAIBioXcel Therapeutics to Report First Quarter 2023 Financial Results on May 8, 2023
BioXcel Therapeutics, Inc. will release its first quarter 2023 financial results on May 8, 2023, before the U.S. market opens. The management team will host a conference call and webcast at 8:00 AM ET to discuss these results and provide a general business update. The company utilizes AI technology to innovate treatments in neuroscience and immuno-oncology, with its commercial product, IGALMI™, currently approved for specific psychiatric conditions.
Read more →BTAIBioXcel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Operational Highlights IGALMI (dexmedetomidine) commercial execution fully underway in 2023 with key focus on market access and
BioXcel Therapeutics reported its financial results for the fourth quarter and full year 2022, noting a significant net loss of $165.8 million and limited revenue generation. However, the launch of IGALMI, a new treatment for agitation in schizophrenia and bipolar disorders, stands out as a positive achievement. The company is also anticipating pivotal data readouts for its BXCL501 and plans to advance BXCL701 into a Phase 2b trial. Despite current challenges with market access and high operational costs, BioXcel emphasizes a strong financial foundation moving forward.
Read more →BTAIBioXcel Therapeutics to Report Fourth Quarter and Full Year 2022 Financial Results on March 9, 2023
BioXcel Therapeutics, Inc. announced it will release its fourth quarter and full year 2022 financial results on March 9, 2023. The company will host a conference call and webcast at 8:30 AM ET to discuss these results and provide a business update. BioXcel focuses on utilizing artificial intelligence to develop new therapeutic indications from existing drugs and is actively involved in the schizophrenia and bipolar treatment space, among other areas.
Read more →BTAIBioXcel Therapeutics | 555 Long Wharf Drive, 12th Floor | New Haven, CT 06511 | www.bioxceltherapeutics.com ® BXCL701 Key Opinion Leader Day
BioXcel Therapeutics recently held a Key Opinion Leader Day, showcasing its pipeline for BXCL701 and other drug candidates. The company plans to initiate several clinical trials, including a Phase 2b study for small cell neuroendocrine prostate cancer, and is in discussions with the FDA regarding these developments. However, the company faces inherent uncertainties as it relies on the success and commercialization of its various products amidst a backdrop of significant losses and regulatory challenges. Forward-looking statements highlighted in the presentation reflect management's expectations and the risks of actual results differing from those anticipated.
Read more →BTAIBioXcel Therapeutics to Ring Nasdaq Stock Market Closing Bell Today
BioXcel Therapeutics, Inc. is set to ring the Nasdaq closing bell today, celebrating notable achievements such as the FDA approval of IGALMI, its first product for treating agitation linked to schizophrenia and bipolar disorders. The CEO, Dr. Vimal Mehta, highlighted plans for market expansion through pivotal study readouts for BXCL501 in early 2023 and positive trial data for BXCL701 in immuno-oncology. This event underscores the company's commitment to AI-driven drug development in neuropsychiatry and oncology.
Read more →BTAIBioXcel Therapeutics Announces Positive Full Data from Phase 2 Trial of BXCL701 in Rare, Aggressive Form of Prostate Cancer; to be Presented at 2023 ASCO Genitourinary Cancers Symposium
BioXcel Therapeutics announced the full results of its Phase 2a trial of BXCL701, which combined with KEYTRUDA®, achieved a 25% composite response rate in patients with metastatic small cell neuroendocrine prostate cancer. Findings will be presented at the 2023 ASCO GU Symposium on February 16, 2023. The company plans to initiate a randomized trial comparing BXCL701 with pembrolizumab to BXCL701 alone. While the data shows promise, a notable percentage of patients experienced serious adverse events related to treatment.
Read more →BTAIBioXcel Therapeutics to Host BXCL701 Key Opinion Leader Day to Highlight Company’s Investigational, Oral Innate Immune Activator for Rare Form of Prostate Cancer
BioXcel Therapeutics, Inc. is hosting a Key Opinion Leader Day on February 21, 2023, focused on their investigational oral innate immune activator, BXCL701, aimed at treating small cell neuroendocrine prostate cancer. The event will feature leading oncology experts who will review Phase 2 trial results and discuss the drug's development and future opportunities. BXCL701 aims to activate the immune system to target aggressive forms of prostate cancer that are less responsive to existing treatments.
Read more →BTAIBioXcel Therapeutics Announces Promising Top-Line Results from Phase 2 Trial of BXCL701 in Aggressive Form of Rare Prostate Cancer
BioXcel Therapeutics announced positive top-line results from a Phase 2 trial of BXCL701 in combination with KEYTRUDA for small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC). The trial demonstrated an encouraging response rate, and full results will be revealed at the upcoming ASCO Genitourinary Cancers Symposium. BXCL701 represents a potential breakthrough as there are currently no approved treatments for this challenging cancer type.
Read more →BTAIBioXcel Therapeutics to Present at 41st Annual J.P. Morgan Healthcare Conference
NEW HAVEN, Conn., Dec. 22, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D.
Read more →BTAIBioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
Pivotal trial will evaluate efficacy and safety of BXCL501 in Alzheimer’s patients in nursing homes with moderate to severe dementia Estimated 100 million annual Alzheimer’s-related agitation episodes1 could potentially increase current U.S. market opportunity for BXCL501 by mor
Read more →BTAIBioXcel Therapeutics to Present at Bank of America 2022 Biotech SMID Cap Conference
NEW HAVEN, Conn., Dec. 01, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D.
Read more →BTAIBioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults with Bipolar I or II Disorder or Schizophrenia
SERENITY III will evaluate the efficacy and safety of BXCL501 for at-home use Top-line pivotal data expected in 1H 2023 Estimated 23 million annual agitation episodes in the home-setting would more than double current market opportunity for BXCL501 in the U.S. 1-4 NEW HAVEN, C
Read more →BTAIBioXcel Therapeutics to Present at Two Upcoming Investor Conferences
NEW HAVEN, Conn., Nov. 14, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D.
Read more →BTAI▲ +29.3%on this news· ran to +41% by day 3shared move
BioXcel Therapeutics Reports Third Quarter 2022 Financial Results and Recent Operational Highlights IGALMI (dexmedetomidine) well-positioned for growth in 2023 based on increasing market access, efficient targeting, favo
BioXcel Therapeutics Reports Third Quarter 2022 Financial Results and Recent Operational Highlights IGALMI (dexmedetomidine) well-positioned for growth in 2023 based on increasing market access, efficient targeting, favorable market drivers, and sales force expansion in all m
Read more →BTAIBioXcel Therapeutics to Report Third Quarter 2022 Financial Results on November 10, 2022
NEW HAVEN, Conn., Oct. 27, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release it
Read more →BTAIBioXcel Therapeutics to Host IGALMI™ Commercial Day on October 18, 2022
NEW HAVEN, Conn., Oct. 05, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will host a Com
Read more →BTAIBioXcel Therapeutics to Participate at the H.C. Wainwright 24th Annual Global Investment Conference
NEW HAVEN, Conn., Sept. 07, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D
Read more →BTAIBioXcel Therapeutics Reports Second Quarter 2022 Financial Results and Recent Operational Highlights Commercially launched IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation in bipolar I or II
BioXcel Therapeutics Reports Second Quarter 2022 Financial Results and Recent Operational Highlights Commercially launched IGALMI (dexmedetomidine) sublingual film for the acute treatment of agitation in bipolar I or II disorder and schizophrenia in adult patients III pivotal
Read more →BTAIBioXcel Therapeutics to Participate at the Canaccord Genuity 42nd Annual Growth Conference
NEW HAVEN, Conn., Aug. 03, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that V
Read more →BTAIBioXcel Therapeutics Announces NIH NIDA Grant to Columbia University to Support Further Studies of BXCL501 (Sublingual Dexmedetomidine) for Treating Opioid Withdrawal
Multi-year-funded award to support a 160-patient, randomized-controlled study in patients undergoing opioid withdrawal treatment Over 142 million opioid prescriptions dispensed in the U.S. in 20201 More than 1.7 million people in the U.S. suffered from substance use disorders r
Read more →BTAIBioXcel Therapeutics to Report Second Quarter 2022 Financial Results on August 9, 2022
NEW HAVEN, Conn., July 26, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that i
Read more →BTAIBioXcel Therapeutics Appoints Michael P. Miller to Board of Directors
NEW HAVEN, Conn., July 05, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the ap
Read more →BTAIBioXcel Therapeutics Announces Updated Presentation Time at H.C. Wainwright Global Investment Conference
NEW HAVEN, Conn., May 20, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vi
Read more →BTAI▼ -9.6%on this news
BioXcel Therapeutics Reports First Quarter 2022 Financial Results and Recent Operational Highlights Received FDA approval of IGALMI (dexmedetomidine) sublingual film for acute treatment of agitation associated with schiz
BioXcel Therapeutics Reports First Quarter 2022 Financial Results and Recent Operational Highlights FDA approval of IGALMI (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults Top-line data read
Read more →BTAI▼ -7.4%on this news· ran to -24% by day 3shared move
BioXcel Therapeutics to Present at Three Upcoming Investor Conferences
NEW HAVEN, Conn., May 05, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vi
Read more →BTAIBioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY II Phase 3 Trial for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
Top-line data for TRANQUILITY II anticipated in Q4 2022/early Q1 2023 Phase 3 TRANQUILITY III study underway with patient enrollment initiating in H2 2022 NEW HAVEN, Conn., May 03, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmac
Read more →BTAI▼ -5.3%on this news
BioXcel Therapeutics to Report First Quarter 2022 Financial Results on May 9, 2022
NEW HAVEN, Conn., April 26, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transformative medicines in neuroscience and immuno-oncology, tod
Read more →BTAIBioXcel Therapeutics Announces Formation of OnkosXcel Therapeutics to Develop Medicines Focused in Oncology
OnkosXcel, a Company subsidiary, to utilize proprietary AI-powered platform to progress therapies to address difficult-to-treat cancers with high unmet need New structure to unlock growth opportunities and maximize value of neuroscience and immuno-oncology franchises Lead pipel
Read more →BTAIBioXcel Therapeutics Announces $260 Million Strategic Financing with Oaktree and Qatar Investment Authority
Investment will support upcoming U.S. commercial launch activities of IGALMI™ and further clinical pipeline development Extends Company’s cash runway into 2025 NEW HAVEN, Conn., April 19, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI) (the “Company” or “BioX
Read more →BTAIBioXcel Therapeutics Announces FDA Approval of IGALMI™ (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults
First and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder1 IGALMI demonstrated onset of action as early as 20 minutes and high response rate with both 120 mcg and 180 mcg doses
Read more →BTAIBioXcel Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Operational Highlights Ready to launch BXCL501 upon approval as Company nears
BioXcel Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Operational Highlights Ready to launch BXCL501 upon approval as Company nears April 5, 2022 PDUFA action date Initiated TRANQUILITY II AND III pivotal Phase 3 trials for BXCL501 in ac
Read more →BTAIBioXcel Therapeutics to Present at the Barclays Global Healthcare Conference
NEW HAVEN, Conn., March 09, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vi
Read more →BTAIBioXcel Therapeutics to Report Fourth Quarter and Full Year 2021 Financial Results on March 10, 2022
NEW HAVEN, Conn., Feb. 24, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it
Read more →BTAIBioXcel Therapeutics Announces Journal of the American Medical Association Publication of Data from SERENITY II Pivotal Phase 3 Trial Evaluating BXCL501 in Bipolar Disorders
BXCL501 demonstrated statistically significant and clinically meaningful improvements in primary and key secondary efficacy measures compared with placebo BXCL501 PDUFA Date is April 5, 2022 for acute treatment of agitation associated with schizophrenia and bipolar disorders NE
Read more →BTAIBioXcel Therapeutics Presents Positive Data from Phase 2 Trial of BXCL701 in Aggressive Forms of Prostate Cancer at 2022 ASCO Genitourinary Cancers Symposium
BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrates encouraging composite response rates in SCNC (33%) and adenocarcinoma (21%) cohorts Company plans to continue evaluation of BXCL701 combination as potentially differentiated approach for mCRPC patients Results support BXCL701’
Read more →BTAIBioXcel Therapeutics to Present at the SVB Leerink 11th Annual Global Healthcare Conference
NEW HAVEN, Conn., Feb. 09, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vim
Read more →BTAIBioXcel Therapeutics Appoints Matt Wiley Chief Commercial Officer
NEW HAVEN, Conn., Jan. 19, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the appo
Read more →BTAIBioXcel Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference
NEW HAVEN, Conn., Jan. 04, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vim
Read more →BTAIBioXcel Therapeutics Initiates Pivotal Phase 3 Program of BXCL501 for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
Two Phase 3 studies to enroll a total of 300 patients in assisted living or residential facilities and nursing homes to evaluate the safety and efficacy of BXCL501 Studies designed to maximize BXCL501 opportunity to treat full spectrum of agitation, with an estimated 100 million
Read more →BTAIBioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
PDUFA date extended by three months to April 5, 2022 No Additional Data Requested Following Meeting with FDA NEW HAVEN, Conn., Dec. 01, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligen
Read more →BTAIBioXcel Therapeutics to Present at the 2021 Jefferies London Healthcare Conference
NEW HAVEN, Conn., Nov. 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vim
Read more →BTAIBioXcel Therapeutics Reports Third Quarter 2021 Financial Results and Recent Operational Highlights Plans for commercial and launch readiness advancing for BXCL501 orally dissolving film, for the acute treatment of agita
BioXcel Therapeutics Reports Third Quarter 2021 Financial Results and Recent Operational Highlights Plans for commercial and launch readiness advancing for BXCL501 orally dissolving film, for the acute treatment of agitation associated with schizophrenia and bipolar disorders
Read more →BTAIBioXcel Therapeutics to Report Third Quarter 2021 Financial Results on November 10, 2021
NEW HAVEN, Conn., Oct. 27, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it
Read more →BTAIBioXcel Therapeutics Announces Expansion of Phase 2 Trial of BXCL701 in De Novo and Treatment-Emergent Small-Cell Neuroendocrine Prostate Cancer
Initial findings from Phase 1b/2 trial of BXCL701 in combination with KEYTRUDA met efficacy threshold to support expansion of existing cohort of de novo and treatment-emergent Small-Cell Neuroendocrine Prostate Cancer (SCNC) High unmet medical need with no FDA approved therapies
Read more →BTAIBioXcel Therapeutics to Highlight Novel Approaches in AI-Based Drug Candidate Discovery and Development and Advances in Neuroscience Portfolio at Virtual R&D Day
Management to showcase AI platform to develop potential treatments for neuropsychiatric disorders Company to introduce BXCL502 program and discuss expansion opportunities for lead program, BXCL501 Event to take place today from 12:00 p.m. – 2:00 p.m. EST NEW HAVEN, Conn., Sept
Read more →BTAIBioXcel Therapeutics Presents Results from Ongoing Phase 2 Trial of BXCL701 in Combination with KEYTRUDA in Aggressive Forms of Prostate Cancer at ESMO
BXCL701 plus KEYTRUDA® (pembrolizumab) demonstrates encouraging anti-tumor activity in heavily pre-treated mCRPC patients with adenocarcinoma BXCL701 combination continues to exhibit favorable safety profile; patient enrollment continues as per protocol NEW HAVEN, Conn., Sept.
Read more →BTAIBioXcel Therapeutics to Present Updates from Ongoing Trial of BXCL701 in Aggressive Forms of Prostate Cancer at 2021 ESMO Congress
NEW HAVEN, Conn., Sept. 12, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-onco
Read more →BTAIBioXcel Therapeutics to Host Virtual R&D Day on September 23, 2021
Live webcast, Revolutionizing Drug Discovery and Development Through AI, to be held from 12:00 PM ET – 2:00 PM ET NEW HAVEN, Conn., Sept. 09, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI) (“BioXcel” or the “Company”), a clinical-stage biopharmaceutical compa
Read more →BTAIBioXcel Therapeutics Reports Second Quarter 2021 Financial Results and Recent Operational Highlights
Phase 3 study of BXCL501 for the acute treatment of agitation associated with dementia expected to begin in Q4 2021 PDUFA date of January 5, 2022 assigned to BXCL501 NDA for the acute treatment of agitation associated with schizophrenia and bipolar disorders I & II Data from ad
Read more →BTAIBioXcel Therapeutics to Report Second Quarter 2021 Financial Results on August 10, 2021
NEW HAVEN, Conn., July 28, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncol
Read more →BTAIBioXcel Therapeutics to Present at Canaccord Genuity 41st Annual Growth Conference
NEW HAVEN, Conn., July 19, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), today announced that Dr. Vimal Mehta, Ph.D., Founder and Chief Executive Officer of BioXcel, will participate in the Canaccord Genuity 41st Annual Growth Co
Read more →BTAIBioXcel Therapeutics Announces Pricing of Public Offering of Common Stock
NEW HAVEN, Conn., June 23, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical development company, today announced the pricing of an underwritten public offering of 3,155,000 shares of common stock at a public of
Read more →BTAIBioXcel Therapeutics Announces Proposed Public Offering of Common Stock
NEW HAVEN, Conn., June 22, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today an
Read more →BTAIBioXcel Therapeutics to Host Virtual Commercial Day on June 25, 2021
NEW HAVEN, Conn., June 18, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncol
Read more →BTAIBioXcel Therapeutics to Participate in Three Upcoming Healthcare Investor Conferences
NEW HAVEN, Conn., May 26, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncolo
Read more →BTAIBioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II
FDA sets PDUFA action date for January 5, 2022 If approved, BXCL501 would represent the first major advancement in the acute treatment of agitation associated with schizophrenia and bipolar disorders in almost a decade NEW HAVEN, Conn., May 19, 2021 (GLOBE NEWSWIRE) -- BioXcel
Read more →BTAIBioXcel Therapeutics Announces Presentations at the ISBD 2021 Global Annual Conference
NEW HAVEN, Conn., May 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncolo
Read more →BTAIBioXcel Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update Granted FDA Breakthrough Therapy designation for BXCL501 for the acute treatment of agitation associated with dementia; regis
BioXcel Therapeutics Reports First Quarter 2021 Financial Results and Provides Granted FDA Breakthrough Therapy designation for BXCL501 for the acute treatment of agitation associated with dementia; registrational program expected to begin in 2H 2021 Submitted NDA to FDA for
Read more →BTAIBioXcel Therapeutics to Participate in Two Upcoming Healthcare Investor Conferences
NEW HAVEN, Conn., May 04, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncolo
Read more →BTAIBioXcel Therapeutics to Host First Quarter 2021 Operating and Financial Results Conference Call and Webcast
NEW HAVEN, Conn., May 03, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncolo
Read more →BTAIBioXcel Therapeutics Launches “Boiling Point” Educational Campaign to Shed Light on the Importance of Prompt and Cooperative De-escalation in the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
The Campaign, launching during Mental Health Awareness Month, aims to educate healthcare providers on the various signs, symptoms, and levels of severity associated with agitation Interactive website offers healthcare providers educational resources and guidance on methods of ma
Read more →BTAIBioXcel Therapeutics Announces Presentations on SERENITY I & II at the 2021 American Psychiatric Association Annual Meeting
NEW HAVEN, Conn., April 26, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-onco
Read more →BTAIBioXcel Therapeutics Announces Results of Phase 1b/2 Study of BXCL501 for the Treatment of Opioid Withdrawal Symptoms
Primary safety endpoint achieved in first study of BXCL501 dosed twice-daily over seven days RELEASE results demonstrated numerically improved retention rates in multiple BXCL501 dose cohorts Data from multiple dosing regimen in RELEASE supports investigation across additional
Read more →BTAIBioXcel Therapeutics Receives FDA Breakthrough Therapy Designation for BXCL501 for the Acute Treatment of Agitation Associated with Dementia
NEW HAVEN, Conn., March 15, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-onco
Read more →BTAIBioXcel Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update New Drug Application ("NDA") submitted to the U.S. Food and Drug Administration ("FDA") for BXCL501 for the ac
BioXcel Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update New Drug Application ("NDA") submitted to the U.S. Food and Drug Administration ("FDA") for BXCL501 for the acute treatment of schizophrenia and bipolar disorder rela
Read more →BTAIBioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
NEW HAVEN, Conn., March 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-onco
Read more →BTAIBioXcel Therapeutics to Host Fourth Quarter and Full Year 2020 Operating and Financial Results Conference Call and Webcast
NEW HAVEN, Conn., March 04, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-onco
Read more →BTAIBioXcel Therapeutics Provides Update on its BXCL501 Program for the Acute Treatment of Dementia Related Agitation
Review of TRANQUILITY data showed 30 mcg dose met statistical significance across multiple scales Company initiated supplemental 40 mcg dose cohort to help inform clinical development strategy across the full range of dementia care settings End of Phase 2 meeting scheduled with
Read more →BTAIBioXcel Therapeutics Appoints June Bray to Board of Directors Former Allergan executive brings extensive global regulatory experience across multiple therapeutic areas
BioXcel Therapeutics Appoints June Bray to Board of Directors Allergan executive brings extensive global regulatory experience across multiple therapeutic HAVEN, Conn., March 1, 2021 -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage b
Read more →BTAIBioXcel Therapeutics Announces Initiation of Phase 2 PLACIDITY Trial of BXCL501 for the Treatment of Delirium Related Agitation
NEW HAVEN, Conn., Feb. 25, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncol
Read more →BTAIBioXcel Therapeutics Appoints Javier Rodriguez as Chief Legal Officer and Corporate Secretary
NEW HAVEN, Conn., Feb. 23, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncol
Read more →BTAIBioXcel Therapeutics to Host Virtual Key Opinion Leader Event to Highlight BXCL501 as a Potential Treatment for Agitation and Opioid Withdrawal Symptoms
NEW HAVEN, Conn., Feb. 12, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncol
Read more →BTAIBioXcel Therapeutics to Present an Update from its Ongoing Trial of BXCL701 in Aggressive Forms of Prostate Cancer at the 2021 ASCO Genitourinary Cancers Symposium
NEW HAVEN, Conn., Feb. 04, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncol
Read more →BTAIBioXcel Therapeutics Announces BXCL501 Met the Primary and All Secondary Endpoints in the TRANQUILITY Phase 1b/2 Study for the Acute Treatment of Agitation in Dementia, including Alzheimer’s Disease
Statistically significant, clinically meaningful, rapid and durable reductions in agitation achieved with the 60 mcg dose as measured by multiple agitation scales BXCL501 was well tolerated with no severe or serious adverse events Results provide a clear path toward initiating
Read more →BTAIBioXcel Therapeutics to Present at the 39th Annual J.P. Morgan Healthcare Conference
Company to present corporate update and plans for 2021 Topline TRANQUILITY data expected to be reported by mid-January NEW HAVEN, Conn., Dec. 17, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical comp
Read more →BTAIBioXcel Therapeutics Announces Grant by U.S. Department of Defense to Evaluate BXCL501 in Patients Suffering from PTSD
NEW HAVEN, Conn., Dec. 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced
Read more →BTAIBioXcel Therapeutics to Participate in the Jefferies Virtual London Healthcare Conference
NEW HAVEN, Conn., Nov. 13, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced
Read more →BTAIBioXcel Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update Complete NDA submission for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders
BioXcel Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update Complete NDA submission for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders on track for Q1 2021 TRANQUILITY and RELEASE studies ar
Read more →BTAIBioXcel Therapeutics Announces Completion of Pre-NDA Meeting with FDA for BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorders
Initiated rolling submission of New Drug Application (“NDA”) with U.S. Food and Drug Administration (“FDA”) On track to submit complete NDA in Q1 2021 NEW HAVEN, Conn., Nov. 11, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clini
Read more →BTAIBioXcel Therapeutics to Present BXCL701 Clinical Data at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting
Encouraging signals of activity in difficult-to-treat tumors observed in both ongoing trials with BXCL701 and pembrolizumab (KEYTRUDA®) NEW HAVEN, Conn., Nov. 09, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmac
Read more →BTAIBioXcel Therapeutics to Host Third Quarter 2020 Operating and Financial Results Conference Call and Webcast
NEW HAVEN, Conn., Nov. 05, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced it
Read more →BTAIBioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with Delirium
NEW HAVEN, Conn., Oct. 26, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced tha
Read more →BTAIBioXcel Therapeutics to Present at the H.C. Wainwright 22nd Annual Global Investment Conference
NEW HAVEN, Conn., Sept. 09, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced th
Read more →BTAIBioXcel Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update SERENITY I & II Phase 3 trials of BXCL501 achieved all primary and secondary endpoints; New Drug Application (" NDA") submis
BioXcel Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update I & II Phase 3 trials of BXCL501 achieved all primary and secondary endpoints; New Drug Application ("NDA") submission to U.S. Food and Drug Administration ("FDA") planned for Q1 20
Read more →BTAIBioXcel Therapeutics to Host Second Quarter 2020 Operating and Financial Results Conference Call and Webcast
NEW HAVEN, Conn., Aug. 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced it
Read more →BTAIBioXcel Therapeutics to Participate in the Canaccord Genuity 40th Annual Growth Conference
NEW HAVEN, Conn., Aug. 06, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced tha
Read more →BTAIBioXcel Therapeutics Announces Primary and Secondary Endpoints Met in Two Pivotal Phase 3 Trials of BXCL501 for the Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder
Highly statistically significant improvements in PEC score observed vs. placebo (p<0.0001) at two hours in the SERENITY trials for both doses tested Statistically significant improvements in PEC score observed as early as 20 minutes after treatment All exploratory endpoints dem
Read more →BTAIBioXcel Therapeutics Announces Compassionate Use Program at Massachusetts General Hospital for BXCL501 to Treat COVID-19 Patients Suffering from Delirium and Agitation
NEW HAVEN, Conn., July 09, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-onco
Read more →BTAIBioXcel Therapeutics Announces Notice of Allowance for U.S. Patent Application Covering Formulation for BXCL501 and Methods of Treating Agitation
NEW HAVEN, Conn., July 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced tha
Read more →BTAIBioXcel Therapeutics Announces Appointment of Reina Benabou, M.D., Ph.D., as Chief Development Officer
NEW HAVEN, Conn., June 23, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced the
Read more →BTAIBioXcel Therapeutics Announces Appointment of William P. Kane as Chief Commercial Officer
NEW HAVEN, Conn., June 16, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced the
Read more →BTAIBioXcel Therapeutics to Participate in Two Upcoming Investor Conferences
NEW HAVEN, Conn., June 15, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced
Read more →BTAIBioXcel Therapeutics Announces First Patient Enrolled in Phase 1b/2 RELEASE Trial of BXCL501 for the Treatment of Opioid Withdrawal Symptoms
NEW HAVEN, Conn., June 11, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced tha
Read more →BTAIBioXcel Therapeutics to Present at the Jefferies Virtual Healthcare Conference
NEW HAVEN, Conn., May 28, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced
Read more →BTAIBioXcel Therapeutics Announces Completion of Patient Enrollment in Phase 3 SERENITY Trials with BXCL501
NEW HAVEN, Conn., May 14, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced full
Read more →BTAIBioXcel Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update Enrollment of the pivotal SERENITY trials is progressing well, with topline data expected in mid-2020 The Company is assessin
BioXcel Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update Enrollment of the pivotal SERENITY trials is progressing well, with topline data expected in mid-2020 The Company is assessing data for dose escalation in the TRANQUILITY study and
Read more →BTAIBioXcel Therapeutics to Present at the UBS Virtual Global Healthcare Conference
NEW HAVEN, Conn., May 11, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced
Read more →BTAIBioXcel Therapeutics to Present at the BofA Securities Virtual Health Care Conference
NEW HAVEN, Conn., May 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced
Read more →BTAIBioXcel Therapeutics to Host First Quarter 2020 Operating and Financial Results Conference Call and Webcast
NEW HAVEN, Conn., May 05, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced it w
Read more →BTAIBioXcel Therapeutics Announces Initiation of a Phase 2 Study of BXCL701 in Combination with a PD-1 Inhibitor for Treatment Emergent Neuroendocrine Prostate Cancer
Completed the Phase 1b safety lead-in, identifying recommended Phase 2 dose of BXCL701 in combination with pembrolizumab (KEYTRUDA®) in advanced prostate cancer Initial interim data readout expected in the fourth quarter of 2020 NEW HAVEN, Conn., April 28, 2020 (GLOBE NEWSWIRE)
Read more →BTAINASDAQ: BTAI Next Wave April 2020 of Medicines Utilizing AI BioXcel Therapeutics, 555 Long Wharf Drive, New Haven, CT 06511 | www.bioxceltherapeutics.com Forward-Looking Statements This presentation includes "forward-loo
Mean Concentration (ng/L) 28 active : 14 placebo Secondary Evaluation: Change in ACES from Baseline Consistent with Primary Endpoint p = <0.0001 5 4 p = <0.0156 3 2 1 * The lowest dose tested, 20 mcg (not shown) was repeated in subjects who did not achieve response criterion 0 Th
Read more →BTAIBioXcel Therapeutics Provides an Update on its Ongoing Phase 3 SERENITY Trials
More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients On track to report topline data from both studies in mid-2020 NEW HAVEN, Conn., March 19, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: B
Read more →BTAIBioXcel Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update Key BXCL501 data readouts expected in mid-2020 - including results from the SERENITY program and the Phase 1b/
Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update Key BXCL501 data readouts expected in mid-2020 - including results from the SERENITY program and the Phase 1b/2 TRANQUILITY trial in geriatric dementia Strengthened balance sh
Read more →BTAIBioXcel Therapeutics to Host Fourth Quarter and Full Year 2019 Operating and Financial Results Conference Call and Webcast
NEW HAVEN, Conn., March 02, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced it
Read more →BTAIBioXcel Therapeutics to Present at Two Upcoming Healthcare Investor Conferences
NEW HAVEN, Conn., Feb. 26, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced tha
Read more →BTAIBioXcel Therapeutics Announces Initiation of a Phase 2 Study Designed to Assess Agitation-Associated Biomarkers and their Response to BXCL501
Study aims to support BXCL501’s potential market expansion in chronic agitation disease conditions Topline results expected in the second quarter of 2020 NEW HAVEN, Conn., Feb. 18, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinic
Read more →BTAIBioXcel Therapeutics to Present at the 2020 BIO CEO & Investor Conference
NEW HAVEN, Conn., Feb. 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immun
Read more →BTAIBioXcel Therapeutics Announces FDA Clearance of IND Application for BXCL501 for the Treatment of Opioid Withdrawal Symptoms
NEW HAVEN, Conn., Feb. 05, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immun
Read more →BTAIBioXcel Therapeutics Announces First Patient Enrolled in Phase 1b/2 Study of BXCL501 for Acute Treatment of Agitation Associated with Dementia
Foundational study with plans to address multiple types of agitation associated with dementia Expands the potential therapeutic use of BXCL501 beyond neuropsychiatric disorders Topline results expected in mid-2020 NEW HAVEN, Conn., Jan. 07, 2020 (GLOBE NEWSWIRE) -- BioXcel The
Read more →BTAIBioXcel Therapeutics Announces Initiation of Pivotal Phase 3 Studies of BXCL501 for Acute Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder
NEW HAVEN, Conn., Dec. 30, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-onco
Read more →BTAIBioXcel Therapeutics to Expand Study of BXCL701 into Multiple Advanced Solid Tumor Types
NEW HAVEN, Conn., Dec. 11, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and i
Read more →BTAIBioXcel Therapeutics Prepares to Initiate Pivotal Phase 3 Studies with BXCL501 Following Positive End-of-Phase 2 Meeting with FDA
The Company plans to initiate the pivotal studies by year end, with topline data reported mid-2020 The first sublingual, non-invasive acute treatment candidate designed for agitation in neuropsychiatric diseases NEW HAVEN, Conn., Dec. 03, 2019 (GLOBE NEWSWIRE) -- BioXcel Therap
Read more →BTAIBioXcel Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update Key data readouts expected for BXCL501 in 1H 2020 including results of pivotal Phase 3 trials with cash position sufficient t
BioXcel Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update Key data readouts expected for BXCL501 in 1H 2020 including results of pivotal Phase 3 trials with cash position sufficient through completion of studies Phase 1b/2 trial for geriatri
Read more →BTAIBioXcel Therapeutics Highlights Upcoming Major Milestones
Clinical results expected 1H 2020 from BXCL501 Phase 3 trial for acute treatment of agitation in Schizophrenia and Bipolar patients Data also expected from BXCL501 Phase 1b in 1H 2020 for acute treatment of agitation in Geriatric Dementia/Alzheimer’s Disease Data readouts expec
Read more →BTAIBioXcel Therapeutics Announces BXCL501 Program Initiative for Prevention and Treatment of Acute Agitation using Wearable Digital Devices
Neuropsychiatric patients are vulnerable to multiple agitation episodes; Alzheimer’s dementia patients specifically require integrated patient management solutions Expands market potential of BXCL501, if approved, beyond traditional treatment paradigms to preventative therapy I
Read more →BTAIBioXcel Therapeutics Receives FDA Orphan Drug Designation for BXCL701 for the Treatment of Acute Myeloid Leukemia (AML)
Expansion of clinical development for BXCL701 program planned in hematological malignancies, beyond solid tumors (Pancreatic and tNEPC) Confirmation and further extension of key findings in Nature Medicine Publication for BXCL701 selectivity for targeting AML by pyroptotic progr
Read more →BTAIBioXcel Therapeutics Announces Award of Grant by U.S. Department of Defense’s (“DoD”) Congressionally Directed Medical Research Programs (“CDMRP”) for Development of BXCL501
Expands clinical development of BXCL501 program for treatment of alcohol and substance use disorders (“ASUD”), related to post-traumatic stress disorder (“PTSD”) and traumatic brain injury (“TBI”) CDMRP aims to fund the study and development of new medications to improve treatme
Read more →BTAIBioXcel Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update BXCL501 met primary endpoint in agitated schizophrenia patients with clinically meaningful, rapid and durable reduction in P
BioXcel Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update BXCL501 met primary endpoint in agitated schizophrenia patients with clinically meaningful, rapid and durable reduction in PEC score maintained for 4 to 6 hours in its Phase 1b, rando
Read more →BTAIBioXcel Therapeutics to Present at the Canaccord Genuity 2019 Annual Growth Conference
NEW HAVEN, Conn., July 31, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will present [on its product candidates] at the Canaccord Genuity 2019 Annual Growth Conference
Read more →BTAIBioXcel Therapeutics to Report Second Quarter and Half Year 2019 Financial Results and Business Update
NEW HAVEN, Conn., July 30, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), today announced that the Company is scheduled to release its second quarter and half year 2019 financial results on Tuesday, August 6, 2019. BTI will also hold a conference call
Read more →BTAIBioXcel Therapeutics Announces BXCL501 Met Primary Endpoint in Phase 1b Placebo-Controlled Trial in the Treatment of Agitation in Patients with Schizophrenia Statistically significant mean reduction in PEC score at two h
BioXcel Therapeutics Announces BXCL501 Met Primary Endpoint in Phase 1b Placebo-Controlled Trial in the Treatment of Agitation in Patients with Schizophrenia Statistically significant mean reduction in PEC score at two hours compared to placebo following a single dose of 180 mcg
Read more →BTAIBioXcel Therapeutics Added to Russell 3000 Index
NEW HAVEN, Conn., July 01, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced that the company has been added to the broad-market Russell 3000® Index following the conclusion of the 2019 Russell indexes annual reconstitution, effective upon
Read more →BTAIBioXcel Therapeutics to Participate in the BMO 2019 Prescriptions for Success Healthcare Conference
NEW HAVEN, Conn., June 18, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will participate in a fireside chat at the BMO 2019 Prescriptions for Success Healthcare Confere
Read more →BTAIBioXcel Therapeutics Completes Dosing Two Cohorts of Agitated Schizophrenia Patients with BXCL501 in a Phase 2 Efficacy Trial
Total of 96 agitated patients and healthy volunteers have received multiple doses of BXCL501, a proprietary sublingual thin film On track to announce top line results from Phase 2 efficacy trial in 3Q 2019 Planning to initiate first Phase 3 pivotal trial in 4Q 2019 NEW HAVEN,
Read more →BTAIBioXcel Therapeutics CEO, Dr. Vimal Mehta to Participate in BIO International Convention Panel on Innovative Clinical Trial Designs
NEW HAVEN, Conn., June 06, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), announced today that Dr. Vimal Mehta, Chief Executive Officer and Founder of BTI, will participate in a panel at the BIO International Convention in Philadelphia, P
Read more →BTAIBioXcel Therapeutics Announces FDA Clearance of IND Application for Triple Combination in Pancreatic Cancer and CTA Acceptance for Double Combination in Aggressive Form of Prostate Cancer (tNEPC) for Lead Immuno-Oncology Program, BXCL701
• FDA clearance of IND for BXCL701 triple combination therapy with Nektar’s bempegaldesleukin and BAVENCIO® (avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer • MHRA (U.K. Medicines and Healthcare products Regulatory Agency) accepts clinical application f
Read more →BTAIBioXcel Therapeutics to Present at the Jefferies 2019 Global Healthcare Conference
NEW HAVEN, Conn., May 31, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-on
Read more →BTAIBioXcel Therapeutics Achieved Targeted Exposures of BXCL501 Designed For Non-Invasive Acute Treatment of Agitation in Neuropsychiatric Diseases Phase 2 efficacy trial in agitated schizophrenia patients anticipated to com
BioXcel Therapeutics Achieved Targeted Exposures of BXCL501 Designed For Non-Invasive Acute Treatment of Agitation in Neuropsychiatric Diseases Phase 2 efficacy trial in agitated schizophrenia patients anticipated to commence imminently BXCL501 is a potential first-in-class sel
Read more →BTAIBioXcel Therapeutics to Highlight Advances in the BXCL501 Program at 2019 Investor Event in New York City
Management to unveil BXCL501 global development strategy and agitation franchise expansion Key Opinion Leaders to discuss acute agitation across multiple disease conditions Webcast scheduled from 9:00 am – 11:30 am ET NEW HAVEN, Conn., May 13, 2019 (GLOBE NEWSWIRE) -- BioXcel
Read more →BTAIBioXcel Therapeutics to Present at the 2019 UBS Global Healthcare Conference
NEW HAVEN, Conn., May 09, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced, that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will present at the 2019 UBS Global Healthcare Conference, being held May 20-22, 2019 in New Yor
Read more →BTAIBioXcel Therapeutics Reports First Quarter 2019 Results and Provides Business Update On track to announce results in May 2019 from recently completed BXCL501 Phase 1 pharmacokinetic (bioavailability) and safety study Adv
BioXcel Therapeutics Reports First Quarter 2019 Results and Provides Business Update On track to announce results in May 2019 from recently completed BXCL501 Phase 1 pharmacokinetic (bioavailability) and safety study Advanced manufacturing of BXCL501 thin film formulation for p
Read more →BTAIBioXcel Therapeutics Advances Process Development for BXCL501 Thin Film Formulation
Automated, scalable process developed for manufacturing clinical and commercial supply BXCL501 thin film architecture is proprietary and flexible for combination therapies Multiple subjects treated with BXCL501 in ascending dose Phase 1 clinical trial Appoints industry veteran
Read more →BTAIBioXcel Therapeutics to Host First Quarter 2019 Financial Results and Business Update
NEW HAVEN, Conn., April 29, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, t
Read more →BTAIBioXcel Therapeutics to Present at Upcoming Investor Conferences in April
NEW HAVEN, Conn., April 03, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced, that the Company will deliver corporate overview presentations at both the H.C Wainwright & Co. Global Life Sciences Conference, April 7-9, 2019 in London, UK a
Read more →BTAIBioXcel Therapeutics Showcases Data on BXCL701 in Combination with OX40 Agonist in Late-breaking Poster Presentation at AACR Annual Meeting Novel combination achieves synergistic anti-tumor effect and survival benefit De
BioXcel Therapeutics Showcases Data on BXCL701 in Combination with OX40 Agonist in Late-breaking Poster Presentation at AACR Annual Meeting Novel combination achieves synergistic anti-tumor effect and survival benefit Demonstrates BXCL701 s potential ability to bridge innate an
Read more →BTAIBioXcel Therapeutics Files Clinical Trial Application for the Development of BXCL701 and Pembrolizumab in Neuroendocrine Prostate Cancer (tNEPC) Expands global footprint for lead immuno-oncology program, BXCL701 Patient
BioXcel Therapeutics Files Clinical Trial Application for the Development of BXCL701 and Pembrolizumab in Neuroendocrine Prostate Cancer (tNEPC) Expands global footprint for lead immuno-oncology program, BXCL701 Patient recruitment in US tNEPC study on-track; additional sites b
Read more →BTAIBioXcel Therapeutics to Present at 29th Annual Oppenheimer Healthcare Conference
NEW HAVEN, Conn., March 13, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced, that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will present at the 29th Annual Oppenheimer Healthcare Conference being held March 19-20, 2019
Read more →BTAI(NASDAQ: BTAI) Next Wave of Medicines March 2019 BioXcel Therapeutics, 555 Long Wharf Drive, New1Haven, CT 06511 | www.bioxceltherapeutics.com Proprietary & Confidential Safe Harbor Statement This document may contain fo
(NASDAQ: BTAI) Next Wave of Medicines March 2019 BioXcel Therapeutics, 555 Long Wharf Drive, New1Haven, CT 06511 | www.bioxceltherapeutics.com Proprietary & Confidential Safe Harbor Statement This document may contain forward-looking statements. Such forward-looking statements a
Read more →BTAIBioXcel Therapeutics Announces Late Breaking Data Presentation at AACR 2019 Annual Meeting
BioXcel Therapeutics Announces Late Breaking Data Presentation at AACR 2019 Annual Meeting NEW HAVEN, Conn., March 11, 2019 (GLOBE NEWSWIRE) BioXcel Therapeutics, Inc. ( BTI ) (BTAI) today announced that it will present a late breaking poster featuring data from a preclinical st
Read more →BTAIBioXcel Therapeutics Reports Fourth Quarter and Full Year 2018 Quarterly Results and Provides Business Update BXCL501 Pharmacokinetic (Bioavailability) and safety study on track to read out in second quarter 2019; initia
BioXcel Therapeutics Reports Fourth Quarter and Full Year 2018 Quarterly Results and Provides Business Update BXCL501 Pharmacokinetic (Bioavailability) and safety study on track to read out in second quarter 2019; initiation of Phase 2/3 Registration Trial expected in second hal
Read more →BTAIBioXcel Therapeutics to Participate in Upcoming Investor Conferences in March
NEW HAVEN, Conn., March 05, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI) today announced, that Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, will present at the 39th Annual Cowen Healthcare Conference being held March 11-13, 2019 in Bo
Read more →BTAIBioXcel Therapeutics Announces Addition of Merck KGaA, Darmstadt, Germany, and Pfizer to Clinical Collaboration with Nektar for Development of Triple-combination Therapy in Pancreatic Cancer Clinical partnership to evalu
BioXcel Therapeutics Announces Addition of Merck KGaA, Darmstadt, Germany, and Pfizer to Clinical Collaboration with Nektar for Development of Triple-combination Therapy in Pancreatic Cancer Clinical partnership to evaluate triple combination of BioXcel Therapeutics BXCL701, Nek
Read more →BTAIBioXcel Therapeutics to Host Fourth Quarter & Full Year 2018 Financial Results and Business Update Conference Call
NEW HAVEN, Conn., March 01, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-
Read more →BTAI(NASDAQ: BTAI) Next Wave of Medicines February 11th, 2019 BioXcel Therapeutics, 555 Long Wharf Drive, New #H aven, CT 06511 | www.bioxceltherapeutics.com Proprietary & Confidential Safe Harbor Statement This document may
(NASDAQ: BTAI) Next Wave of Medicines February 11th, 2019 BioXcel Therapeutics, 555 Long Wharf Drive, New #H aven, CT 06511 | www.bioxceltherapeutics.com Proprietary & Confidential Safe Harbor Statement This document may contain forward-looking statements. Such forward-looking s
Read more →BTAIBioXcel Therapeutics to Present at 2019 BIO CEO & Investor Conference
NEW HAVEN, Conn., Feb. 06, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), today announced that Dr. Vimal Mehta, Chief Executive Officer of BTI, will present at the upcoming 2019 BIO CEO & Investor Conference being held in New York, NY on
Read more →BTAIBioXcel Therapeutics Expands Indication for Lead Neuroscience Asset, BXCL501, to Treat Symptoms Associated with Opioid Drug Withdrawal
Clinical benefit observed in 10 of 10 patients; Human proof-of-concept established Provides further evidence of BXCL501’s mechanism of action Expands clinical advisory board with four additional industry leaders to guide on global development and market expansion of BXCL501 NE
Read more →BTAI(NASDAQ: BTAI) BXCL501: An Acute Treatment
(NASDAQ: BTAI) BXCL501: An Acute Treatment January 03, 2019 for Agitation BioXcel Therapeutics, 555 Long Wharf Drive, New Haven, CT 06511 | www.bioxceltherapeutics.com Proprietary & Confidential Agenda 01 02 BXCL501 PROGRAM OVERVIEW CLINICAL TRIALS RESULTS WITH IV DEXMEDETOMIDIN
Read more →BTAIBioXcel Therapeutics Reports Positive Human Proof-of-Concept Data for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
Primary endpoint (safety and tolerability) met, with clinical benefit observed in 7 of 10 patients Proof-of-Concept established in agitated patients across multiple underlying disorders including Alzheimer’s Disease, Schizophrenia, and Delirium Trial data, coupled with upcoming
Read more →BTAIconditions and the factors described under the caption Risk Factors in BioXcel s Form 10Q for the period ending
BioXcel Therapeutics Receives FDA Fast Track Designation for BXCL501 for Acute Treatment of Agitation Fast track designation for BXCL501 will help facilitate anticipated registration trials in 2019 upon completion of pharmacokinetic (bioavailability) and safety study NEW HAVEN,
Read more →BTAIBioXcel Therapeutics Receives FDA Fast Track Designation for BXCL501 for Acute Treatment of Agitation
NEW HAVEN, Conn., Dec. 27, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), today announced that the U.S. FDA has granted Fast Track Designation for its investigational drug BXCL501, a proprietary sublingual film of dexmedetomidine, for the
Read more →BTAIBioXcel Therapeutics Doses First Subjects in Pharmacokinetic (Bioavailability) and Safety Study of BXCL501 for the Acute Treatment of Agitation Data read-out expected in 1H 19 Results expected to support dose selection f
BioXcel Therapeutics Doses First Subjects in Pharmacokinetic (Bioavailability) and Safety Study of BXCL501 for the Acute Treatment of Agitation Data read-out expected in 1H 19 Results expected to support dose selection for anticipated registration trials in 2019 NEW HAVEN, Con
Read more →BTAIBioXcel Therapeutics Announces FDA Acceptance of IND for Lead Neuroscience Candidate, BXCL501 for the Acute Treatment of Agitation First-in-human pharmacokinetic (bioavailability) study with sublingual thin-film formulat
BioXcel Therapeutics Announces FDA Acceptance of IND for Lead Neuroscience Candidate, BXCL501 for the Acute Treatment of Agitation First-in-human pharmacokinetic (bioavailability) study with sublingual thin-film formulation Patient recruitment initiated and data read-out expec
Read more →BTAI(NASDAQ: BTAI) Next Wave of Medicines BioXcel Therapeutics, 555 Long Wharf Drive, New #H aven, CT 06511 | www.bioxceltherapeutics.com Proprietary & Confidential Safe Harbor Statement This document may contain forward-loo
(NASDAQ: BTAI) Next Wave of Medicines BioXcel Therapeutics, 555 Long Wharf Drive, New #H aven, CT 06511 | www.bioxceltherapeutics.com Proprietary & Confidential Safe Harbor Statement This document may contain forward-looking statements. Such forward-looking statements are charac
Read more →BTAIBioXcel Therapeutics to Present at BMO Capital Markets 2018 Prescriptions for Success Healthcare Conference
NEW HAVEN, Conn., Dec. 03, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-o
Read more →BTAIBioXcel Therapeutics Reports Positive Results from Study in Agitated Schizophrenia Patients Supporting BXCL501 Clinical Development Primary endpoint met, clinical benefit observed in 9 of 10 patients treated with intrave
BioXcel Therapeutics Reports Positive Results from Study in Agitated Schizophrenia Patients Supporting BXCL501 Clinical Development Primary endpoint met, clinical benefit observed in 9 of 10 patients treated with intravenously (IV)-dosed Dexmedetomidine(Dex); no meaningful respo
Read more →BTAIBioXcel Therapeutics Reports Third Quarter 2018 Quarterly Results and Provides Business Update
BioXcel Therapeutics Reports Third Quarter 2018 Quarterly Results and Provides Business Update NEW HAVEN, Conn., November 9, 2018 -- BioXcel Therapeutics, Inc. ( BTI ) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence
Read more →BTAIBioXcel Therapeutics Announces FDA Acceptance of IND for Lead Immuno-oncology Candidate, BXCL701, in Treatment Emergent Neuroendocrine Prostate Cancer First-in-human Phase 1b / 2 combination trial of BXCL701 and pembroli
BioXcel Therapeutics Announces FDA Acceptance of IND for Lead Immuno-oncology Candidate, BXCL701, in Treatment Emergent Neuroendocrine Prostate Cancer First-in-human Phase 1b / 2 combination trial of BXCL701 and pembrolizumab (Keytruda ) expected to initiate in 4Q 2018 Efficacy
Read more →BTAIBioXcel Therapeutics to Host Third Quarter 2018 Financial Results and Business Update Conference Call
Conference call scheduled for November 09, 2018 at 8:00 AM ET NEW HAVEN, Conn., Nov. 02, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to ident
Read more →BTAIBioXcel Therapeutics Announces Presentation on Functional Immunological Memory Formation Across Diverse Tumor Types at the SITC 2018 Annual Meeting
Data underscores the potential of triple combination of BXCL701, NKTR-214 and an anti-PD1 agent as an anti-cancer therapy NEW HAVEN, Conn., Oct. 31, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company
Read more →BTAIBioXcel Therapeutics Provides Update on the Clinical Advancement of BXCL501 for the Acute Treatment of Agitation On track to initiate BXCL501 first-in-human pharmacokinetic (bioavailability) and safety study Data readout
BioXcel Therapeutics Provides Update on the Clinical Advancement of BXCL501 for the Acute Treatment of Agitation On track to initiate BXCL501 first-in-human pharmacokinetic (bioavailability) and safety study Data readout expected first half 2019 NEW HAVEN, Conn; October 30, 20
Read more →BTAIBioXcel Therapeutics to Present at the 2018 BIO Investor Forum
NEW HAVEN, Conn., Oct. 11, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-o
Read more →BTAIBioXcel Therapeutics Announces Submission of IND for Lead Immuno-oncology Candidate, BXCL701, in Treatment Emergent Neuroendocrine Prostate Cancer
NEW HAVEN, Conn., Oct. 08, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-o
Read more →BTAIBioXcel Therapeutics Expands Immuno-Oncology Partnership with Nektar into Clinical Development in Pancreatic Cancer Clinical partnership to develop triple combination of BioXcel Therapeutics BXCL701, Nektar s NKTR-214 an
BioXcel Therapeutics Expands Immuno-Oncology Partnership with Nektar into Clinical Development in Pancreatic Cancer Clinical partnership to develop triple combination of BioXcel Therapeutics BXCL701, Nektar s NKTR-214 and a checkpoint inhibitor NEW HAVEN, Conn; September 24, 20
Read more →BTAIBioXcel Therapeutics Enhances Leadership with Appointment of Chetan D. Lathia, Ph.D. as Senior Vice President, and Head of Translational Medicine, Clinical Pharmacology and Regulatory Affairs
NEW HAVEN, Conn., Sept. 18, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence (“AI”) approaches to identify the next wave of medicines across neuroscience and
Read more →BTAIBioXcel Therapeutics Appoints Dr. David C. Hanley as Vice President and Head of Global Pharmaceutical Development and Operations
BRANFORD, Conn., Sept. 04, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, to
Read more →BTAIBioXcel Therapeutics to Present at the 20th Annual HC Wainwright Global Investment Conference
NEW HAVEN, Conn., Aug. 28, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-o
Read more →BTAIBioXcel Therapeutics Establishes Immuno-Oncology Clinical Advisory Board to Advance BXCL701 Development
NEW HAVEN, Conn., Aug. 22, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-o
Read more →BTAIBioXcel Therapeutics Reports Second Quarter 2018 Financial Results and Provides Business Update Clinical programs in neuroscience (BXCL501) and immuno-oncology (BXCL701) on track Company strengthens business operations a
BioXcel Therapeutics Reports Second Quarter 2018 Financial Results and Provides Business Update Clinical programs in neuroscience (BXCL501) and immuno-oncology (BXCL701) on track Company strengthens business operations and infrastructure NEW HAVEN, Conn., Aug 8, 2018 BioXcel T
Read more →BTAIBioXcel Therapeutics Strengthens Leadership Team with Industry Veteran Michael De Vivo Ph.D. as Vice President, Neuroscience
NEW HAVEN, Conn., Aug. 07, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence (AI) approaches to identify the next wave of medicines across neuroscience and imm
Read more →BTAIBioXcel Therapeutics to Host Second Quarter 2018 Financial Results and Business Update
Conference call scheduled on August 8, 2018 at 4:30 PM ET NEW HAVEN, Conn., Aug. 02, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify
Read more →BTAIBioXcel Therapeutics to Present at the 38th Annual Canaccord Genuity Growth Conference
NEW HAVEN, Conn., Aug. 02, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-o
Read more →BTAIBioXcel Therapeutics Enhances Leadership with Appointment of Vikas Sharma, Ph.D. as Vice President of Business Development
NEW HAVEN, Conn., July 31, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-on
Read more →BTAIDPP8/9 Inhibition - The Primary Mechanism of BioXcel Therapeutics Lead Immuno-Oncology Asset, BXCL701, Highlighted in Peer-Reviewed Journal Nature Medicine article expands upon mechanistic findings and presents DPP8/9 in
DPP8/9 Inhibition - The Primary Mechanism of BioXcel Therapeutics Lead Immuno-Oncology Asset, BXCL701, Highlighted in Peer-Reviewed Journal Nature Medicine article expands upon mechanistic findings and presents DPP8/9 inhibition as potential treatment for various cancer types B
Read more →BTAIBioXcel Therapeutics Forms Neuroscience Clinical Advisory Board to Support Global Development of BXCL501
NEW HAVEN, Conn., July 10, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, tod
Read more →BTAIBioXcel Therapeutics Reports Positive Results from Phase 1b Trial of Intravenously-dosed Dexmedetomidine Supporting BXCL501 Development Optimal exposure levels for developing BXCL501 sublingual thin film identified Resul
BioXcel Therapeutics Reports Positive Results from Phase 1b Trial of Intravenously-dosed Dexmedetomidine Supporting BXCL501 Development Optimal exposure levels for developing BXCL501 sublingual thin film identified Results support clinical evaluation of dexmedetomidine in acute
Read more →BTAIBioXcel Therapeutics Added to Russell Microcap Index
BRANFORD, Conn., June 26, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, toda
Read more →BTAIBioXcel Therapeutics Appoints Dr. Cedric Burg as Vice President and Head of Global Clinical Operations and Project Management
Building strong clinical team to effectively support robust clinical programs Dr. Burg to leverage his international experience to expand the Company’s clinical trials globally BRANFORD, Conn., June 13, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI),
Read more →BTAINext Wave of Medicines BioXcel Therapeutics, 780 East Main Street, Branford, CT 06405 www.bioxceltherapeutics.com (NASDAQ: BTAI) Safe Harbor Statement This document may contain forward-looking statements. Such forward-lo
Next Wave of Medicines BioXcel Therapeutics, 780 East Main Street, Branford, CT 06405 www.bioxceltherapeutics.com (NASDAQ: BTAI) Safe Harbor Statement This document may contain forward-looking statements. Such forward-looking statements are characterized by future or conditional
Read more →BTAIBioXcel Therapeutics Appoints Vincent J. O Neill M.D., as Senior Vice President and Chief Medical Officer Dr. O Neill takes on pivotal role as the Company moves its pipeline forward
BioXcel Therapeutics Appoints Vincent J. O Neill M.D., as Senior Vice President and Chief Medical Officer Dr. O Neill takes on pivotal role as the Company moves its pipeline forward BRANFORD, Conn., June 07, 2018 (GLOBE NEWSWIRE) BioXcel Therapeutics, Inc. ( BTI ) (Nasdaq:BTAI)
Read more →BTAIBioXcel Therapeutics to Present at the Jefferies 2018 Global Healthcare Conference
BRANFORD, Conn., June 05, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, toda
Read more →BTAIBioXcel Therapeutics and Nektar Therapeutics Present Preclinical Pancreatic Cancer Data for BXCL701, NKTR-214 and Anti-PD1 Combination Therapy at ASCO 2018 Annual Meeting BXCL701 in Combination with NKTR-214 and anti-PD-
BioXcel Therapeutics and Nektar Therapeutics Present Preclinical Pancreatic Cancer Data for BXCL701, NKTR-214 and Anti-PD1 Combination Therapy at ASCO 2018 Annual Meeting BXCL701 in Combination with NKTR-214 and anti-PD-1 Therapy Leads to Complete and Sustained Tumor Regression
Read more →BTAINext Wave of Medicines BioXcel Therapeutics, 780 East Main Street, Branford, CT 06405 www.bioxceltherapeutics.com Safe Harbor Statement This document may contain forward-looking statements. Such forward-looking statement
Next Wave of Medicines BioXcel Therapeutics, 780 East Main Street, Branford, CT 06405 www.bioxceltherapeutics.com Safe Harbor Statement This document may contain forward-looking statements. Such forward-looking statements are characterized by future or conditional verbs such as
Read more →BTAIBioXcel Therapeutics to Present at 2018 UBS Global Healthcare Conference
BRANFORD, Conn., May 18, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, today
Read more →BTAIBioXcel Therapeutics Announces Data Presentation at ASCO 2018 Annual Meeting
BioXcel Therapeutics Announces Data Presentation at ASCO 2018 Annual Meeting BRANFORD, Conn., May 17, 2018 BioXcel Therapeutics, Inc. ( BTI ) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave
Read more →BTAIBioXcel Therapeutics Reports First Quarter 2018 Financial Results and Provides Business Update
BioXcel Therapeutics Reports First Quarter 2018 Financial Results and Provides Business Update BRANFORD, Conn., May 14, 2018 BioXcel Therapeutics, Inc. ( BTI ) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to ident
Read more →BTAIBioXcel Therapeutics Announces Acceptance of Abstract at ASCO 2018 Annual Meeting
BioXcel Therapeutics Announces Acceptance of Abstract at ASCO 2018 Annual Meeting BRANFORD, Conn., April 26, 2018 BioXcel Therapeutics, Inc. ( BTI ) (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the nex
Read more →BTAIBioXcel Therapeutics to Ring the NASDAQ Stock Market Opening Bell on April 20, 2018
BRANFORD, Conn., April 19, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, tod
Read more →BTAIBioXcel Therapeutics Announces Closing of Initial Public Offering
BRANFORD, Conn., March 12, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq:BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, tod
Read more →BTAIBioXcel Therapeutics Announces Pricing of Initial Public Offering
BioXcel Therapeutics Announces Pricing of Initial Public Offering BRANFORD, Conn. Mar. 8, 2018 BioXcel Therapeutics, Inc. ( BTI ), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neurosc
Read more →BTAIBioXcel Therapeutics Files Registration Statement for Proposed Initial Public Offering
BRANFORD, Conn., Feb. 13, 2018 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, today announced th
Read more →BTAIBioXcel Therapeutics to Present Data on [BXCL701] at the 24th Annual Prostate Cancer Foundation Scientific Retreat
BRANFORD, Conn., Oct. 05, 2017 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, a biopharmaceutical company committed to developing novel drugs targeting immuno-oncology and neurological and psychiatric diseases, today announced the presentation of new data supporting the Company’s lead
Read more →BTAIBioXcel Therapeutics, Inc. (BTI) Is Launched with Phase 2-ready Programs Addressing Unmet Needs in Immuno-oncology and Neuroscience
BRANFORD, Conn., May 10, 2017 (GLOBE NEWSWIRE) -- BioXcel Corporation, a privately held biopharmaceutical company pioneering the integration of big data analytics and machine learning-based artificial intelligence (AI) with drug development expertise to advance the next wave of m
Read more →BTAIBioXcel Presents Promising Data Demonstrating BXCL701 / Anti-PD1 Combination Increases Anti-Tumor Cytokines and Tumor Growth Inhibition at 2017 AACR Annual Meeting
BRANFORD, Conn., April 03, 2017 (GLOBE NEWSWIRE) -- BioXcel, a biopharmaceutical company integrating big data analytics and machine learning-based artificial intelligence (AI) with drug development expertise to advance the next wave of medicines, today announced that it will pres
Read more →BTAIBioXcel Appoints Eric K. Rowinsky, M.D. to its Board of Directors
BRANFORD, Conn., Jan. 05, 2017 (GLOBE NEWSWIRE) -- BioXcel, a privately held biopharmaceutical company pioneering the integration of big data analytics and machine learning-based artificial intelligence (AI) with drug development expertise to advance the next wave of medicines, t
Read more →BTAIBioXcel and Centrexion Therapeutics Further Advance Big Data Innovation Lab Collaboration in Chronic Pain
BRANFORD, Conn., Oct. 19, 2016 (GLOBE NEWSWIRE) -- BioXcel Corporation, a privately held biopharmaceutical company pioneering the integration of big data analytics and machine learning-based artificial intelligence (AI) with drug development expertise to advance the next wave of
Read more →BTAIBioXcel Appoints Dr. Peter Mueller as Chairman of Scientific Advisory Board
BRANFORD, Conn., Oct. 12, 2016 (GLOBE NEWSWIRE) -- BioXcel, a privately held biopharmaceutical company based in Connecticut, today announced the appointment of Dr. Peter Mueller, Ph.D. as Chairman of its Scientific Advisory Board (“SAB”), which will serve as a strategic resource
Read more →BTAIBioXcel’s BXCL101, Receives Orphan Drug Designation from the U.S. FDA for the Treatment of Patients with Neurofibromatosis Type 2 (NF2)
BRANFORD, Conn., Sept. 13, 2016 (GLOBE NEWSWIRE) -- BioXcel, a privately held biopharmaceutical company based in Connecticut, today announced that the U. S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BXCL101 for the treatment of Neurofibromatosis Ty
Read more →BTAIBioXcel Begins Strategic Collaboration with Alnylam to Discover Novel RNAi Therapeutic Products
BRANFORD, Conn., May 24, 2016 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in real-time big data platforms for the discovery and development of transformative patient treatments, today announced the initiation of a strategic collaboration with Alnylam Pharmaceuticals
Read more →BTAIBioXcel to Present at the 3rd International Conference on the Progress of Regenerative Medicine and its Cultural Impact at the Vatican
BRANFORD, Conn., April 27, 2016 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in cloud-based big data platforms and developer of transformative patient treatments, today announced that Dr. Krishnan Nandabalan, Chief Scientific Officer and President, will present at the
Read more →BTAIBioXcel Celebrates 10th Anniversary as Leader of Big Data Revolution in Healthcare
GURGAON, India, Feb. 18, 2016 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in cloud-based big data platforms and developer of transformative patient treatments, and its Gurgaon-based subsidiary and Integrated Center of Xcellence, E.Z. BioXcel (EZB), today announced th
Read more →BTAIBioXcel Expands Into CNS Orphan Disease Therapeutics
BRANFORD, Conn., Feb. 08, 2016 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in cloud-based big data platforms and developer of transformative patient treatments, today announced its expansion into CNS Orphan Diseases that require novel treatment solutions for neurolog
Read more →BTAIBioXcel Strengthens Position in Immuno-Oncology With Dedicated Big Data Analytics Platform
BRANFORD, Conn., Jan. 21, 2016 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in cloud-based big data platforms and developer of transformative patient treatments, today announced the launch of its first in class PharmGPS® Oncology and Immuno-Oncology Suite. The platfor
Read more →BTAIBioXcel and Centrexion Partner to Develop Novel Chronic Pain Therapies
BRANFORD, Conn., Jan. 11, 2016 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in developing cloud-based big data platforms and transformative patient treatments, today announced a strategic big data collaboration with Centrexion Therapeutics to develop a portfolio of cl
Read more →BTAIBioXcel Initiates Strategic Big Data Partnership With Pronutria
BRANFORD, Conn., Oct. 20, 2015 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in cloud-based big data platforms and developer of transformative patient treatments, today announced the initiation of a strategic big data collaboration with Pronutria Biosciences to identif
Read more →BTAIBioXcel Unveils Next-Generation Big Data Analytics Platform: PharmGPS(TM) 2.0
BRANFORD, Conn., Oct. 7, 2015 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in cloud-based big data platforms and developer of transformative patient treatments, today announced the launch of the latest version of its cloud-based pharma big data analytics platform - Ph
Read more →BTAIBioXcel Strengthens Leadership Team With Two Key Appointments
BRANFORD, Conn., June 16, 2015 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in providing cloud-based Pharma big data solutions for discovering novel products, today announced the appointments of Frank Yocca, Ph.D. as Senior Vice President, CNS R&D, and Luca Rastelli,
Read more →BTAIBioXcel Announces Poster Presentation at AACR Annual Meeting 2015
BRANFORD, Conn., April 17, 2015 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in providing cloud-based Pharma big data solutions for discovering novel products, today announced a poster presentation at the 106th Annual Meeting of the American Association for Cancer Res
Read more →BTAIBioXcel and Takeda Partner to Repurpose Assets for Orphan Diseases
BRANFORD, Conn., April 9, 2015 (GLOBE NEWSWIRE) -- BioXcel Corporation, a global leader in providing cloud-based Pharma big data solutions for discovering novel products, announced today that it has entered into a partnership with Takeda Development Center Americas ("Takeda"), fo
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