| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Milestone Pharmaceuticals Inc.$1.28
-0.02 (-1.43%)
B 64Pipeline Score Undervalued Pharma · Clinical
Market Cap
175.54 M
EPS
-0.68
P/E Ratio
-
Value Trade
1.06 M
SEC Financials
Q1 2026Dilution Risk
Revenue
238.00 K
R&D Expenses
3.25 M
Operating CF
-16.05 M
Total Assets
193.73 M
Total Liabilities
157.69 M
Equity
36.05 M
D/E Ratio
12,345
-10.76 %
Week
-26.94 %
1 Month
-15.57 %
3 Month
-40 %
6 Month
-74.91 %
5 Year
-90.97 %
All Time
Cash Data
Cash Position
184.22 M
Monthly Burn
5.35 M
Runway
32.7 mo
Burn Trend
SEC Filing
May 13, 2026
Overview
Volume
457.24 K
52 Week Range
1 - 3.06
% held by Insiders
0.9 %
% held by Institutions
23.99 %
Enterprise Value
128.65 M
Total Shares
124.53 M
Short %
11.13 %
Float Shares
113.19 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Milestone Pharmaceuticals Inc.
181Total events
4Upcoming
66Tier-1 (high impact)
2019 – 2036Coverage
Upcoming catalysts 4
Event history 177
May 19, 2026
◆Oral PresentationPresentation
Presentation at H.C. Wainwright 4th Annual BioConnect Investor Conference at NASDAQ
May 13, 2026
May 13, 2026
▲Other Regulator MilestoneEtripamilEx-US Regulatory
EMA MAA accepted for review
paroxysmal supraventricular tachycardia (PSVT)source ↗
May 13, 2026
▲Trial InitiationEtripamilTrial
Phase 3 registrational program in AFib-RVR initiated
atrial fibrillation with rapid ventricular rate (AFib-RVR)source ↗
May 13, 2026
●Poster PresentationEtripamilPresentation
Details on RESET-PSVT registry presented at PCNA 2026
paroxysmal supraventricular tachycardia (PSVT)source ↗
May 13, 2026
●Oral PresentationEtripamilPresentation
Reduction in Health Care Utilization presentation at Stanford BioDesign
paroxysmal supraventricular tachycardia (PSVT)source ↗
Apr 13, 2026
◆Oral PresentationPresentation
Management to present at 25th Annual Needham Virtual Healthcare Conference
Mar 30, 2026
●Poster PresentationCARDAMYSTApprovedPresentation
Poster presentation at ACC Annual Scientific Session: Minimal Blood Pressure Effects of Intranasal Etripamil for PSVT
PSVTsource ↗
Mar 20, 2026
▲EU MAA SubmissionEtripamilEx-US Regulatory
MAA for etripamil nasal spray in PSVT accepted by EMA
PSVTsource ↗
Mar 20, 2026
Mar 3, 2026
Drug Pipeline Intelligence
B64
Pipeline Score $2.6B
Pipeline ValueUndervalued
Valuation Signal8
Drugs Scored15.0x
rNPV / MCap Top 91%
Micro Cap (rank 83 of 911)
Percentile RankMilestone Pharmaceuticals Inc. holds a solid B-grade pipeline (64/100), with $11.9B risk-adjusted pipeline value, led by CX11 in Type II Diabetes Mellitus (Phase 2).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CX11 Small molecule | Obesity | Phase 2 | NCT07011797 | 43% | $9.1B | ACTIVE NOT_RECRUITING | 250 | AVERAGE | B (67) | Apr 6, 2026 | - | LOW May 24, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
etripamil Breakthrough | recurrent paroxysmal supraventricular tachycardia (PSVT) | Phase 3 | 2024-04-08 | conversion rate 30 minutes: 60%; conversion rate 60 minutes: 69.9%; median time to conversion: 17.0 minutes Read More | Milestone Pharmaceuticals Announces Etripamil Data Demonstrating Patients' Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting Data from this large safety-trial also publ Read More | |
etripamil Breakthrough | recurrent paroxysmal supraventricular tachycardia (PSVT) | Phase 3 | 2024-04-08 | conversion rate 30 minutes: 60%; conversion rate 60 minutes: 69.9%; median time to conversion: 17.0 minutes Read More | Milestone Pharmaceuticals Announces Etripamil Data Demonstrating Patients' Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting Data from this large safety-trial also publ Read More | |
etripamil Breakthrough | recurrent paroxysmal supraventricular tachycardia (PSVT) | Phase 3 | 2024-04-08 | conversion rate 30 minutes: 60%; conversion rate 60 minutes: 69.9%; median time to conversion: 17.0 minutes Read More | Milestone Pharmaceuticals Announces Etripamil Data Demonstrating Patients' Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting Data from this large safety-trial also publ 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 MIST
| 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 |
MIST 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 | |
| 2026-09-18 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2026-09-18 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2026-09-18 | 0.00 | 0 | - | - | - | - | - | - | ||||
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
MIST▼ -5.2%on this news· ran to -17% by day 3
Milestone Pharmaceuticals to Present at the H.C. Wainwright 4th Annual BioConnect Investor Conference at NASDAQ
Milestone Pharmaceuticals Inc. will present at the H.C. Wainwright 4th Annual BioConnect Investor Conference on May 19, 2026. The presentation will include a live webcast available for 90 days after the event. Milestone is known for its innovative cardiovascular medicines, including the FDA-approved CARDAMYST™ nasal spray.
Read more →MIST▼ -9.5%on this news· ran to -23% by day 3shared move
Milestone Pharmaceuticals Announces First Quarter 2026 Financial Results and Provides Corporate Update
Milestone Pharmaceuticals reported positive first quarter 2026 results, highlighting strong early adoption of its CARDAMYST nasal spray for PSVT. The company secured national formulary coverage with Express Scripts and initiated a Phase 3 trial for Atrial Fibrillation-RVR. Despite a net loss of $26.1 million, Milestone maintains a solid cash position to support ongoing operations.
Read more →MISTMilestone Pharmaceuticals to Announce First Quarter 2026 Financial Results on May 13, 2026
Milestone Pharmaceuticals Inc. will announce its financial results for Q1 2026 on May 13, 2026, before market opening. The announcement will be accompanied by a conference call and webcast for investors at 8:30 AM ET. The company focuses on innovative cardiovascular treatments, including its FDA-approved product CARDAMYST™.
Read more →MIST▲ +5.9%on this news· ran to +33% by day 3
Milestone Pharmaceuticals to Present at the 25th Annual Needham Virtual Healthcare Conference
Milestone Pharmaceuticals Inc. will present at the 25th Annual Needham Virtual Healthcare Conference from April 13-16, 2026. The presentation is scheduled for April 13 at 3:45 PM EDT, with a webcast available for viewing. The company focuses on innovative cardiovascular medicines, including its FDA-approved product, CARDAMYST™.
Read more →MIST▼ -20%on this news
Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Update on the Commercial Launch of CARDAMYST™ (etripamil) Nasal Spray for the Treatment of PSVT
Milestone Pharmaceuticals reported strong financial results for Q4 and full year 2025, highlighted by the FDA approval of CARDAMYST, a nasal spray for PSVT. The product's launch is on track with positive early engagement from healthcare providers. The company also plans to expand its indications for etripamil, including a Phase 3 program for AFib-RVR.
Read more →MISTMilestone Pharmaceuticals to Announce Fourth Quarter and Full-Year 2025 Financial Results on March 20, 2026
Milestone Pharmaceuticals Inc. will announce its fourth quarter and full-year 2025 financial results on March 20, 2026. The announcement will precede a conference call and webcast for investors at 8:30 AM ET. The company is known for its innovative cardiovascular medicines, including the FDA-approved CARDAMYST™ nasal spray.
Read more →MISTMilestone® Pharmaceuticals to Present at the TD Cowen 46th Annual Health Care Conference
Milestone Pharmaceuticals announced that key executives will present at the TD Cowen 46th Annual Health Care Conference from March 2-4, 2026, in Boston. The presentation will be available via webcast on March 3 at 9:10 AM EST, with a replay accessible for 90 days. The company focuses on innovative cardiovascular treatments, including its FDA-approved product, CARDAMYST™.
Read more →MISTMilestone Pharmaceuticals Appoints David Sandoval as General Counsel and Chief Compliance Officer
Milestone Pharmaceuticals has appointed David Sandoval as General Counsel and Chief Compliance Officer. His extensive experience in legal and compliance within the life sciences sector will support the launch of CARDAMYST, the first self-administered treatment for PSVT. Sandoval aims to enhance the company's legal framework and drive shareholder value.
Read more →MISTMilestone Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Milestone Pharmaceuticals announced the grant of 419,000 stock options to incentivize two new employees as part of its 2021 Inducement Plan. The options, priced at $1.96 per share, will vest over four years. This move aligns with Nasdaq Listing Rule 5635(c)(4) and reflects the company's commitment to attracting talent.
Read more →MISTMilestone Pharmaceuticals Announces U.S. Availability of CARDAMYST™ (etripamil) Nasal Spray, the First and Only FDA-Approved Self-Administered Treatment for Adults with Paroxysmal Supraventricular Tachycardia (PSVT)
Milestone Pharmaceuticals has announced the U.S. availability of CARDAMYST (etripamil) nasal spray, the first FDA-approved self-administered treatment for adults with paroxysmal supraventricular tachycardia (PSVT). The product aims to provide patients with a convenient option for managing acute episodes of PSVT. A national sales force will support its launch, and the company is negotiating with insurers to ensure affordability and coverage.
Read more →MISTMilestone Pharmaceuticals Announces Acceptance of Marketing Authorization Application for Etripamil Nasal Spray in PSVT by the European Medicines Agency - A European decision on approval is expected by Q1 2027 - If appro
Milestone Pharmaceuticals announced that the European Medicines Agency has accepted its Marketing Authorization Application for etripamil nasal spray, intended for the treatment of paroxysmal supraventricular tachycardia (PSVT). This application builds upon successful clinical trials demonstrating etripamil's efficacy and safety, suggesting it could become a novel self-administered therapy in Europe. A decision on the approval is anticipated by Q1 2027. The drug is designed to provide rapid relief for PSVT, improving management and quality of life for patients.
Read more →MISTFDA Approval Investor Call
Milestone Pharmaceuticals held an investor call discussing the FDA approval process for CARDAMYST, a treatment for paroxysmal supraventricular tachycardia (PSVT). The presentation emphasized the potential benefits of CARDAMYST, including its ability to deliver rapid therapeutic relief and its well-tolerated profile according to clinical trials. The management detailed their commercialization plans and addressed potential market challenges, while also evaluating the implications of forward-looking statements related to future approvals and economic factors. The company aims to empower patients and relieve pressure on healthcare systems with this new treatment.
Read more →MISTMilestone Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Regulatory and Corporate Update
Milestone Pharmaceuticals reported its third-quarter financial results and provided updates on its lead product, CARDAMYST (etripamil) nasal spray, targeting paroxysmal supraventricular tachycardia (PSVT). The company anticipates a PDUFA target date of December 13, 2025, for FDA approval. With $82.6 million in cash and a successful equity offering, Milestone is preparing for a potential launch.
Read more →MISTMilestone Pharmaceuticals to Present New Analysis from Investigational Etripamil Nasal Spray Clinical Trials for PSVT at the American Heart Association Scientific Sessions 2025
Milestone Pharmaceuticals announced new analyses of its investigational etripamil nasal spray for paroxysmal supraventricular tachycardia (PSVT), demonstrating consistent efficacy and safety across various studies. The findings will be presented at the American Heart Association Scientific Sessions 2025. Etripamil aims to allow patients to self-administer treatment, potentially reducing emergency room visits for PSVT.
Read more →MISTMilestone® Pharmaceuticals to Present Data on Etripamil at the American Heart Association Scientific Sessions 2025
Milestone Pharmaceuticals will present data on etripamil at the AHA Scientific Sessions 2025. The presentation will focus on the drug's efficacy, safety, and tolerability for patients with paroxysmal supraventricular tachycardia. This follows the company's recent submission of a New Drug Application to the FDA for etripamil.
Read more →MISTMilestone® Pharmaceuticals to Present at Upcoming Conferences
Milestone Pharmaceuticals Inc. announced that its President and CEO, Joe Oliveto, will participate in one-on-one meetings at the Wells Fargo Healthcare Conference and provide a corporate update at the H.C. Wainwright 27th Annual Global Investment Conference. A webcast of the presentation will be available for viewing after the event. The company is focused on developing cardiovascular medicines and has submitted a New Drug Application for etripamil.
Read more →MIST▲ +7.1%on this news
Milestone Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Regulatory and Corporate Update FDA Accepted the Company's Response to the CRL for CARDAMYST (etripamil) Nasal Spray; New PDUFA Target
Milestone Pharmaceuticals has reported its second-quarter financial results for 2025 alongside important regulatory updates. The FDA has accepted their response to the Complete Response Letter (CRL) for the CARDAMYST (etripamil) nasal spray, which targets PSVT, with a new PDUFA date set for December 13, 2025. Milestone has also secured significant funding through public offerings and royalty agreements, enhancing its financial stability and operational capacity. However, the company still faces ongoing net losses and uncertainty regarding future regulatory approvals.
Read more →MIST▼ -10.3%on this news· ran to -21% by day 1
Milestone Pharmaceuticals Announces Pricing of $52.5 Million Public Offering of Common Shares, Pre-Funded Warrants, Series A Common Warrants and Series B Common Warrants
Milestone Pharmaceuticals has announced the pricing of a public offering aimed at raising $52.5 million. The offering includes common shares and warrants, with proceeds designated for the clinical development of etripamil for paroxysmal supraventricular tachycardia (PSVT). The offering is expected to close on July 14, 2025, pending customary conditions.
Read more →MIST▼ -39.1%on this newsshared move
Milestone Pharmaceuticals Announces Proposed Public Offering
Milestone Pharmaceuticals has announced a proposed public offering of its common shares and warrants. The proceeds from this offering will be used to fund the clinical development and commercial launch of etripamil for treating paroxysmal supraventricular tachycardia (PSVT). The offering is subject to market conditions, and there is no assurance regarding its completion or terms.
Read more →MIST▼ -39.1%on this newsshared move
Milestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray
Milestone Pharmaceuticals announced that the FDA has accepted its response to the Complete Response Letter (CRL) for CARDAMYST (etripamil) nasal spray, with a new PDUFA action date of December 13, 2025. Concurrently, the company extended its $75 million Royalty Purchase Agreement with RTW Investments to support the anticipated launch of CARDAMYST. The FDA has not raised concerns regarding the clinical section of the NDA.
Read more →MISTMilestone Pharmaceuticals Submits Response to the FDA’s CRL for CARDAMYST (etripamil) Nasal Spray for PSVT Following Type A Meeting
Milestone Pharmaceuticals has submitted its response to the FDA's Complete Response Letter for CARDAMYST (etripamil) nasal spray, aimed at treating paroxysmal supraventricular tachycardia (PSVT). Following a productive Type A meeting with the FDA, the company is optimistic about the potential approval timeline. Etripamil, if approved, would be the first self-administered therapy for PSVT, allowing patients greater control over their condition.
Read more →MISTMilestone Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Regulatory and Corporate Update Resolution of CRL Manufacturing issues in progress - Type A meeting requested No clinical safety or effi
Milestone Pharmaceuticals has reported its financial results for the first quarter of 2025 and provided updates on its regulatory status. The company is currently addressing issues related to a Complete Response Letter (CRL) from the FDA for its product, CARDAMYST, used for treating Paroxysmal Supraventricular Tachycardia (PSVT). A Type A meeting with the FDA has been requested to help resolve these manufacturing concerns. The company's lead investigational product, Etripamil, is noted for its innovative self-administration potential, although the financial report reflects an increased net loss compared to the prior year.
Read more →MIST▼ -60.9%on this news
FDA Issues Complete Response Letter for Etripamil for PSVT CRL focused on CMC; no clinical issues relating to etripamil raised $69.7M in cash, cash equivalents and short-term investments as of
Milestone Pharmaceuticals Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding its New Drug Application for etripamil nasal spray, intended for treating PSVT. Notably, the FDA did not raise any clinical concerns about the drug’s safety or efficacy. Instead, the CRL primarily addressed Chemistry, Manufacturing, and Controls (CMC) issues, which Milestone aims to resolve. The company plans to request a Type A meeting with the FDA to discuss these concerns and remains confident in the drug's potential as a self-administered treatment option for patients.
Read more →MIST▲ +5.2%on this news· ran to +23% by day 3
Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Regulatory and Corporate Update FDA PDUFA review goal date of
Milestone Pharmaceuticals has announced its financial results for the fourth quarter and full year 2024, along with an update on regulatory matters. The company is awaiting FDA's response set for March 27, 2025, regarding its nasal spray, CARDAMYST, aimed at treating paroxysmal supraventricular tachycardia (PSVT). If approved, Milestone plans to launch CARDAMYST mid-2025 and believes it can enhance patient self-management of PSVT. However, there are uncertainties around regulatory approvals and ongoing clinical trials that may impact the company's future.
Read more →MISTCommercial Investor Event: Preparation for Potential Launch of CARDAMYST (etripamil) Nasal Spray Joe Oliveto, President & CEO Lorenz Muller, CCO Investigational Product. Not approved for commercial use in any jurisdictio
Milestone has outlined preparations for the potential launch of CARDAMYST, an investigational nasal spray for paroxysmal supraventricular tachycardia (PSVT), during a recent investor event. Expected FDA approval is set for March 27, 2025, and the company aims to implement a cost-effective launch strategy that includes payer profiling, demand generation, and patient support services. The goal is to achieve broad coverage with low out-of-pocket costs for patients while ensuring a streamlined prescribing process for healthcare providers. Anticipated milestones include a commercial launch scheduled for mid-2025.
Read more →MISTMilestone Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Regulatory and Corporate Update NDA for CARDAMYST in PSVT under review by FDA; PDUFA
Milestone Pharmaceuticals reported its financial results for Q3 2024, highlighting a significant net loss and the ongoing review of its new drug application for CARDAMYST (etripamil) nasal spray by the FDA. The company is optimistic about the potential benefits of CARDAMYST for managing paroxysmal supraventricular tachycardia (PSVT) and plans to commence Phase 3 clinical trials for AFib-RVR in the first half of 2025. Despite the positive outlook, the absence of revenue and significant operational losses present challenges for Milestone's financial health.
Read more →MIST▲ +7.2%on this news
Milestone Pharmaceuticals Appoints Industry Veteran Joseph Papa to its Board of Directors MONTREAL and CHARLOTTE, N.C.
Milestone Pharmaceuticals has appointed Joseph Papa, a seasoned industry veteran, to its Board of Directors, effective September 3, 2024. Papa brings over 35 years of experience in the pharmaceutical sector, previously holding leadership roles in multiple companies. His appointment is expected to enhance Milestone's strategic direction as it aims for the approval of its investigational drug, CARDAMYST, for treating paroxysmal supraventricular tachycardia. The company aims to improve the management of complex cardiovascular conditions and is optimistic about future developments.
Read more →MIST▲ +6%on this news
Milestone Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Regulatory and Corporate Update - NDA for CARDAMYST in PSVT accepted by FDA in 2Q 2024; PDUFA in March 2025 - Cash of $83.3 million as
Milestone Pharmaceuticals reported its financial results for the second quarter of 2024 and highlighted key regulatory updates, including the FDA's acceptance of its New Drug Application for CARDAMYST, a nasal spray intended for patients with paroxysmal supraventricular tachycardia (PSVT). The company's cash reserves of $83.3 million are expected to sustain operations through 2026. Additionally, they noted encouraging feedback from cardiology experts regarding their Phase 3 study for atrial fibrillation with rapid ventricular rate, anticipated to begin in 2025.
Read more →MISTMilestone Pharmaceuticals Refreshes Board of Directors - Two New Independent Directors, Stuart Duty and Andrew Saik, Appointed - Third New Independent Director to Be Appointed to Board in Near Term MONTREAL and CHARLOTTE
Milestone Pharmaceuticals has refreshed its Board of Directors by appointing Stuart Duty and Andrew Saik as new independent directors. Both appointees bring extensive experience in the biotechnology and finance sectors, and a third independent director will be appointed soon. This move comes alongside a Cooperation Agreement with a significant shareholder, indicating strong support for the company's future direction. Additionally, the company has confirmed that two current board members will not be seeking reelection at the upcoming Annual Meeting.
Read more →MISTMilestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST Montreal and Charlotte, N.C., May, 29, 2024 -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) , a biopharmaceutical company focused
Milestone Pharmaceuticals Inc. announced the FDA's acceptance of its New Drug Application for CARDAMYST (etripamil) on May 26, 2024. This nasal spray is aimed at managing paroxysmal supraventricular tachycardia (PSVT) and represents significant progress in the company's mission to provide effective treatment. The PDUFA target date for approval is set for 10 months post-acceptance. The acceptance is based on the clinical program showcasing extensive data supporting CARDAMYST as a potential self-management therapy for PSVT patients.
Read more →MISTMilestone Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Regulatory and Corporate Update - NDA for etripamil in PSVT resubmitted in 1Q 2024 - Cash resources as of
Milestone Pharmaceuticals reported its first quarter 2024 financial results and provided a regulatory update on its lead investigational product, etripamil. The company has resubmitted the NDA for etripamil for treating paroxysmal supraventricular tachycardia (PSVT) and is engaged in finalizing the Phase 3 protocol for atrial fibrillation with rapid ventricular rate (AFib-RVR). Expected cash resources are projected to sustain operations until 2026, with the potential FDA approval for CARDAMYST anticipated in the first half of 2025. The product aims to provide a new self-administered treatment option for patients experiencing these heart conditions.
Read more →MISTMilestone Pharmaceuticals Announces Etripamil Data Demonstrating Patients' Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting Data from this large safety-trial also publ
Milestone Pharmaceuticals has announced new clinical data on etripamil, an investigational drug for treating recurrent paroxysmal supraventricular tachycardia (PSVT). Presented at The American College of Cardiology Annual Meeting and published in a prestigious journal, the study highlights the potential of etripamil to enable patients to self-manage PSVT episodes effectively. The findings indicate a significant rate of conversion to sinus rhythm and a favorable safety profile. Etripamil, if approved, could become a novel treatment option for patients suffering from this common heart condition.
Read more →MISTMilestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia Montreal and Charlotte, N.C.
Milestone Pharmaceuticals has announced the resubmission of its New Drug Application (NDA) for etripamil, aimed at treating paroxysmal supraventricular tachycardia (PSVT). The company claims to have addressed previous FDA concerns noted in a Refusal to File letter, and they are optimistic regarding the approval process. Etripamil is a novel nasal spray intended for self-administration, providing patients with an on-demand therapy option for managing PSVT episodes. If approved, it could significantly improve treatment methods for this condition.
Read more →MISTMilestone Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Regulatory and Corporate Update - On track to resubmit NDA for etripamil in PSVT early 2Q 2024 - Recent financing extends
Milestone Pharmaceuticals reported its fourth quarter and full year 2023 financial results, highlighting a forthcoming resubmission of its New Drug Application (NDA) for etripamil in treating paroxysmal supraventricular tachycardia (PSVT) in early Q2 2024. The company also announced that its recent financing will extend its cash runway into 2026, providing a stronger foundation for its continued operations. Additionally, the FDA has reiterated its prior guidance on the regulatory pathway for AFib-RVR, with plans for an End of Phase 2 meeting expected by mid-2024.
Read more →MISTMilestone Pharmaceuticals Announces Proposed Public Offering of Common Shares and Pre-Funded Warrants MONTREAL, QC and CHARLOTTE, N.C.
Milestone Pharmaceuticals Inc. has announced a proposed public offering of common shares and pre-funded warrants to raise capital for further development of its lead product, etripamil. The offering is contingent on market conditions, and while it aims to fund clinical efforts against paroxysmal supraventricular tachycardia and potential atrial fibrillation indications, there are uncertainties regarding its completion and regulatory approval timelines. A 30-day option for underwriters to purchase additional shares is part of this offering strategy.
Read more →MIST▲ +24.1%on this news
Milestone Pharmaceuticals Announces Plan to Resubmit NDA for Etripamil for the Treatment of PSVT Resubmission of NDA expected 2Q2024 Operating Runway Extended Into Mid-2025 with Cash Conservation Measures Montreal, QC an
Milestone Pharmaceuticals has announced a plan to resubmit its New Drug Application (NDA) for etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT), with expectations for resubmission in the second quarter of 2024. Following a Type A meeting with the FDA, the company believes its approach to address previous regulatory concerns will be successful. Cash conservation measures have been adopted to extend the company's operational runway through mid-2025. If approved, etripamil represents a potentially significant new treatment option for patients suffering from PSVT.
Read more →MIST▼ -30.9%on this news· ran to -42% by day 3
Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT Montreal and Charlotte, N.C.
Milestone Pharmaceuticals Inc. received a Refusal to File letter from the FDA regarding its New Drug Application for etripamil, a nasal spray aimed at treating paroxysmal supraventricular tachycardia (PSVT). The FDA indicated that the submission was not sufficiently complete for review, specifically requesting clarification on adverse event data from Phase 3 trials. Despite this setback, Milestone is planning a meeting with the FDA to discuss the issues and potential steps forward. The company defended etripamil's clinical efficacy, as it demonstrated positive results during trials, including rapid conversion of patients from SVT to healthy sinus rhythm.
Read more →MIST▼ -19.6%on this news
Milestone Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Clinical and Corporate Updates - New Drug Application submitted to the U.S. Food and Drug Administration for CARDAMYST , the conditional
Milestone Pharmaceuticals Inc. has reported its financial results for Q3 2023 and announced the submission of its first New Drug Application for CARDAMYST, aimed at treating Paroxysmal Supraventricular Tachycardia (PSVT). The company highlighted positive results from a Phase 2 study of etripamil for patients with Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR). Moving forward, Milestone is confident about its lead asset, etripamil, and its clinical development strategy as they approach 2024.
Read more →MIST▼ -19.6%on this news
Company Overview CONFIDENTIAL Atrial Fibrillation Program Update November 2023 Forward Looking Statement 2 Milestone - Atrial Fibrillation Program Overview The Presentation contains forward - looking statements within th
Milestone Pharmaceuticals has provided an update on its Atrial Fibrillation program, highlighting progress in the clinical development of etripamil. The company has outlined key milestones, including the recent NDA submission for paroxysmal supraventricular tachycardia (PSVT) and initial data presentations from ongoing clinical studies. However, various risks linked to the drug's regulatory approval and capital resources were noted. Forward-looking statements caution stakeholders about potential uncertainties in the development process.
Read more →MISTMilestone Pharmaceuticals to Host Investor and Analyst Webcast to Review Data from ReVeRA Phase 2 Study of Etripamil in AFib-RVR - Cardiac Electrophysiology Key Opinion Leaders joining the webcast include A. John Camm, M
Milestone Pharmaceuticals has announced a virtual investor and analyst webcast scheduled for November 13, 2023, to discuss data from the ReVeRA Phase 2 study of etripamil, which targets atrial fibrillation with rapid ventricular rate (AFib-RVR). Key opinion leaders in electrophysiology will participate in this presentation, underscoring the study's significance. Etripamil, a novel nasal spray treatment, aims to provide patients with self-administered care for symptomatic episodes associated with AFib-RVR. The webcast will include insights from Milestone's management and results from the ongoing research.
Read more →MISTMilestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil Submission seeks approval for treatment of an abnormal heart rhythm, Paroxysmal Supraventricular Tachycardia or PSVT Co
Milestone Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for etripamil, aimed at treating paroxysmal supraventricular tachycardia (PSVT). This submission is bolstered by the results of the pivotal RAPID Phase 3 clinical trial, which demonstrated etripamil's superior efficacy in converting abnormal heart rhythms compared to placebo. If approved, etripamil, branded as CARDAMYST, is expected to empower patients to manage their PSVT symptoms independently. The FDA will review the NDA within 60 days to determine its completeness.
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Milestone Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Clinical and Corporate Update - NDA submission for etripamil in patients with PSVT expected in October 2023 - Data featured during oral
Milestone Pharmaceuticals has reported its second quarter financial results while providing an update on its clinical advancements, particularly the NDA submission for etripamil targeted for October 2023. The company has completed enrollment in the ReVeRA Phase 2 study for etripamil in patients with AFib-RVR and anticipates topline data in the fourth quarter. Etripamil is positioned as a novel nasal spray therapy aimed at empowering patients with PSVT and AFib-RVR to manage their conditions more effectively.
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Milestone Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Clinical and Corporate Update - NDA submission for etripamil in patients with PSVT currently on track for 3Q23 - Company to host virtual
Milestone Pharmaceuticals has reported its first quarter financial results for 2023, highlighting an NDA submission for etripamil set for the third quarter. The company is also preparing for a virtual event discussing etripamil's potential in treating atrial fibrillation with rapid ventricular rate. Additionally, they anticipate topline data from the Phase 2 ReVeRA study later this year. While financial results showed an increase in net loss, strategic financing is projected to support operations through mid-2025.
Read more →MISTCompany Overview
Milestone Pharma discussed its progress on the etripamil clinical trials for PSVT and AFib - RVR, highlighting positive FDA feedback regarding the NDA filing plan for PSVT expected in Q3 2023. The company announced the completion of two Phase 3 PSVT trials and noted the potential of etripamil to provide significant benefits for patients experiencing symptomatic attacks. They emphasized the challenges they may face, including risks associated with product development and regulatory approvals. Milestone continues to target the unmet needs in the management of common heart conditions.
Read more →MISTMilestone Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical and Corporate Update - Year-end cash resources, together with $125 million proceeds from March 2023 strategic fi
Milestone Pharmaceuticals Inc. reported its financial results for Q4 and the full year 2022, highlighting a strong cash position with resources extending into mid-2025. The company is advancing the development of its lead product etripamil and is on track for a New Drug Application submission in Q3 2023. Additionally, the recent appointment of Seth Fischer to the Board is seen as a strategic move to bolster commercialization efforts. The article emphasizes the significance of etripamil as a potential first-line treatment for paroxysmal supraventricular tachycardia (PSVT).
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Milestone Pharmaceuticals Announces $125 Million Strategic Financing with RTW Investments to Support the Advancement of Etripamil for PSVT - Proceeds from strategic financing together with year-end cash resources expecte
Milestone Pharmaceuticals has announced a strategic financing round totaling $125 million with RTW Investments to support the development of etripamil, aimed at treating paroxysmal supraventricular tachycardia (PSVT). This funding, combined with existing cash resources, is expected to sustain the company's operations through mid-2025 and facilitate the submission of a New Drug Application (NDA) in the third quarter of 2023. Etripamil is designed to empower patients to manage their PSVT attacks outside emergency settings, offering a potential new therapy that addresses a significant patient need.
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Corporate Overview March 2023 Forward Looking Statement 2 Milestone Corporate Overview The Presentation contains forward - looking statements within the meaning of the safe harbor provisions of the Private Securities Lit
Milestone Pharmaceuticals provided a corporate overview highlighting the positive feedback received from the FDA regarding the NDA filing proposal for etripamil, aimed at treating PSVT. The company remains on track for NDA submission in Q3 2023 following the completion of two Phase 3 trials. Etripamil shows promise to empower patients by allowing self-administration, demonstrating potential benefits for both patients and the healthcare system. However, the company also acknowledged the inherent risks and uncertainties associated with biopharmaceutical development, including the outcomes of ongoing clinical trials.
Read more →MIST▲ +9.5%on this news
Milestone Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Clinical and Corporate Update - Phase 3 RAPID trial of etripamil in patients with PSVT achieved primary efficacy endpoint; safety and to
Milestone Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Clinical and Corporate Update Phase 3 RAPID trial of etripamil in patients with PSVT achieved primary efficacy endpoint; safety and tolerability data from repeat dose administration consisten
Read more →MIST▼ -21.7%on this news· ran to -38% by day 3
Milestone Pharmaceuticals Announces Positive Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with Paroxysmal Supraventricular Tachycardia Trial met its primary endpoint, with 64.3% of patie
Milestone Pharmaceuticals Announces Positive Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with Paroxysmal Supraventricular Tachycardia Trial met its primary endpoint, with 64.3% of patients self-administering etripamil converting to sinus rhy
Read more →MISTMilestone Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Clinical and Corporate Update - Phase 3 RAPID study reached the target of 180 confirmed PSVT events treated with double-blind study med
Milestone Pharmaceuticals Reports Second Quarter 2022 Financial Results Clinical and Corporate Update Phase 3 RAPID study reached the target of 180 confirmed PSVT events treated with double-blind study medication required to initiate primary efficacy analysis; topline data re
Read more →MIST▲ +9.3%on this news
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID: 271) 2 Consolidated Balance Sheets 3 Consolidated Statements of Loss 4 Consolidated Statements of Shareholders
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID: 271) 2 Consolidated Balance Sheets 3 Consolidated Statements of Loss 4 Consolidated Statements of Shareholders' Equity 5 Consolidated Statements of Cash Flows 6 Notes to
Read more →MIST▼ -5.4%on this news
Milestone Pharmaceuticals Announces Appointment of David Bharucha, M.D., Ph.D., as Chief Medical Officer Montreal and Charlotte, N.C.
Milestone Pharmaceuticals Announces Appointment of David Bharucha, M.D., Ph.D., as Chief Medical Officer Montreal and Charlotte, N.C., February 16, 2022 -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercializati
Read more →MIST▲ +8.9%on this news· ran to +24% by day 1
Milestone Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Clinical and Corporate Update Montreal and Charlotte, N.C.
Milestone Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Clinical and Corporate Update Montreal and Charlotte, N.C., Nov. 12, 2021 -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercia
Read more →MISTJoseph Oliveto President & CEO Corporate Overview June 2021 Disclaimers The Presentation contains forward - looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform
Joseph Oliveto President & CEO Corporate Overview June 2021 Disclaimers The Presentation contains forward - looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 , as amended . Words such as aim,'' anticipate,
Read more →MISTMilestone Pharmaceuticals Announces Exclusive License Agreement with Ji Xing Pharmaceuticals to Develop and Commercialize Etripamil for PSVT in Greater China - Ji Xing Pharmaceuticals to develop and commercialize etripam
Milestone Pharmaceuticals Announces Exclusive License Agreement with Ji Xing Pharmaceuticals to Develop and Commercialize Etripamil for PSVT in Greater China - Ji Xing Pharmaceuticals to develop and commercialize etripamil for patients with PSVT in Greater China - - Milestone
Read more →MISTITEM 8. FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm To the Shareholders and Board of Directors of Milestone Pharmaceuticals Inc. Opinion on the Financial Statements We have audited the ac
Report of Independent Registered Public Accounting Firm To the Shareholders and Board of Directors of Milestone Pharmaceuticals Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Milestone Pharmaceuticals Inc. and its sub
Read more →MISTMilestone Pharmaceuticals Announces Pricing of a Public Offering of $45 Million of Common Shares and Pre-Funded Warrants MONTREAL and CHARLOTTE, N.C.
Milestone Pharmaceuticals Announces Pricing of a Public Offering of $45 Million of Common Shares and Pre-Funded Warrants MONTREAL and CHARLOTTE, N.C., Oct. 23, 2020 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical- stage biopharmaceutical compa
Read more →MISTMilestone Pharmaceuticals Strengthens Board of Directors with Two New Appointments Montreal and Charlotte, N.C.
Milestone Pharmaceuticals Strengthens Board of Directors with Two New Appointments Montreal and Charlotte, N.C., September 22, 2020 -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative card
Read more →MISTMilestone Pharmaceuticals Announces Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT - Recently completed NODE-301 and ongoing NODE-301B studies can be used as two efficacy studies supporti
Milestone Pharmaceuticals Announces Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT - Recently completed NODE-301 and ongoing NODE-301B studies can be used as two efficacy studies supporting a future NDA submission (target p-values of <0.05)
Read more →MISTMilestone Pharmaceuticals Announces Topline Results from First-of-its-kind Phase 3 NODE-301 Trial of Etripamil for At-home Acute PSVT Treatment - Study missed primary endpoint of mean time to conversion of SVT to SR over
Pharmaceuticals Announces Topline Results from First-of-its-kind Phase 3 NODE-301 Trial of Etripamil for At-home Acute PSVT Treatment - Study missed primary endpoint of mean time to conversion of SVT to SR over a five-hour period following dosing (p=0.12) - - Etripamil showed
Read more →MISTCorporate Overview December 2019 Joseph Oliveto Chief Executive Officer Disclaimers This Presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigat
December 2019 Joseph Oliveto Chief Executive Officer Presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, you can identify forward-looking statements
Read more →MISTMilestone Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Clinical and Corporate Update NODE-301 topline data readout expected in mid-1H20 Richard Pasternak, M.D. appointed to the Company s Boar
Milestone Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Clinical and Corporate Update NODE-301 topline data readout expected in mid-1H20 Richard Pasternak, M.D. appointed to the Company s Board of Directors Montreal and Charlotte, NC, November 13, 2
Read more →MISTMilestone Pharmaceuticals Announces Appointment of Amit Hasija as Chief Financial Officer and Executive Vice President of Corporate Development Montreal and Charlotte, NC
Milestone Pharmaceuticals Announces Appointment of Amit Hasija as Chief Financial Officer and Executive Vice President of Corporate Development Montreal and Charlotte, NC, September 10, 2019 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutica
Read more →MISTMilestone Pharmaceuticals Provides Positive Regulatory Updates for Etripamil Pivotal Program in PSVT and Reports Second Quarter 2019 Financial Results - FDA agrees to allow initiation of NODE-303 open-label safety study
Milestone Pharmaceuticals Provides Positive Regulatory Updates for Etripamil Pivotal Program in PSVT and Reports Second Quarter 2019 Financial Results - FDA agrees to allow initiation of NODE-303 open-label safety study without test dose and in population consistent with ongoing
Read more →MISTMilestone Pharmaceuticals Inc. Condensed Consolidated Financial Statements (Unaudited) Three months ended
Milestone Pharmaceuticals Inc. Condensed Consolidated Financial Statements Three months ended March 31, 2019 and 2018 (expressed in US dollars) Milestone Pharmaceuticals Inc. Condensed Consolidated Balance Sheets (in thousands of US dollars, except share data) March 31,
Read more →MISTMilestone Pharmaceuticals Announces Closing of Initial Public Offering Montreal, QC, CA, and Charlotte, NC
Milestone Pharmaceuticals Announces Closing of Initial Public Offering Montreal, QC, CA, and Charlotte, NC, May 13, 2019 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing etripamil for th
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