| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
NDA Submission example | NDA | — | Subscribe to access the data. | Small Molecules | Nervous System | ||
NDA Submission example | NDA | — | Subscribe to access the data. | Small Molecules | Nervous System | ||
NDA Submission example | NDA | — | Subscribe to access the data. | Small Molecules | Nervous System |
Recent Updates
Recently added Catalysts
Grace Therapeutics, Inc.$2.45
+0.01 (+0.41%)
B 60Pipeline Score Undervalued Pharma · Commercial
Market Cap
34.04 M
EPS
-0.36
P/E Ratio
-
Value Trade
461.92 K
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
420.00 K
Operating CF
-2.22 M
Total Assets
66.65 M
Total Liabilities
2.76 M
Equity
63.90 M
D/E Ratio
12,345
1.38 %
Week
-52.48 %
1 Month
-43.01 %
3 Month
-30.38 %
6 Month
-90.67 %
5 Year
-99.63 %
All Time
Cash Data
Cash Position
16.98 M
Monthly Burn
739.00 K
Runway
22.5 mo
Burn Trend
StableSEC Filing
Jun 18, 2026
Overview
Volume
123.26 K
52 Week Range
1.79 - 5.18
% held by Insiders
27.3 %
% held by Institutions
25.97 %
Enterprise Value
15.37 M
Total Shares
15.47 M
Short %
20.53 %
Float Shares
8.30 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Grace Therapeutics, Inc.
261Total events
1Upcoming
76Tier-1 (high impact)
2013 – 2026Coverage
Upcoming catalysts 1
Event history 260
Q3 2026
●Runway Guidance UpdateCorporate
Cash runway into Q3 2026, potentially into Q2 2027 if warrants exercised
Jun 18, 2026
◆Type A MeetingGTX-104FDA Meeting
Type A meeting scheduled with FDA to discuss NDA resubmission path
aneurysmal Subarachnoid Hemorrhage (aSAH)source ↗
Jun 18, 2026
Jun 2026
◆Type A MeetingGTX-104FDA Meeting
Type A meeting scheduled with FDA to clarify path to resubmission
aneurysmal subarachnoid hemorrhage (aSAH)source ↗
Apr 23, 2026
◆PDUFA DateGTX-104Regulatory Filing
PDUFA target date for GTx-104 NDA
aneurysmal subarachnoid hemorrhage (aSAH)source ↗
Apr 23, 2026
▼Complete Response LetterGTX-104FDA Decision
FDA issued Complete Response Letter for GTx-104 NDA citing CMC and non-clinical items
aneurysmal subarachnoid hemorrhage (aSAH)source ↗
Apr 23, 2026
▲FDA Filing AcceptedGTX-104Regulatory Filing
FDA acceptance for review of NDA for GTx-104
aneurysmal Subarachnoid Hemorrhage (aSAH)source ↗
Apr 21, 2026
◆Poster PresentationGTX-104Presentation
Abstract accepted for poster presentation at AAN 2026
aneurysmal subarachnoid hemorrhage (aSAH)source ↗
Apr 18, 2026
●Oral PresentationGTX-104Presentation
Phase 3 STRIVE-ON trial results presented at 2026 American Academy of Neurology
aneurysmal Subarachnoid Hemorrhage (aSAH)source ↗
Apr 2026
▼Complete Response LetterGTX-104FDA Decision
FDA issued Complete Response Letter for GTx-104 NDA
aneurysmal subarachnoid hemorrhage (aSAH)source ↗
Q2 2026
Drug Pipeline Intelligence
B60
Pipeline Score $355M
Pipeline ValueUndervalued
Valuation Signal5
Drugs Scored15.0x
rNPV / MCap Top 88%
Micro Cap (rank 110 of 911)
Percentile RankGrace Therapeutics, Inc. holds a solid B-grade pipeline (60/100), with $7.0B risk-adjusted pipeline value, led by FF/UMEC/VI in Asthma (Phase 3).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FF/UMEC/VI Small molecule | Asthma | Phase 3 | NCT04651777 | 64% | $4.9B | ACTIVE NOT_RECRUITING | 31 | - | - | Dec 1, 2025 | - | LOW May 26, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
GTx-104 Orphan | aneurysmal subarachnoid hemorrhage (aSAH) | Phase 3 | 2026-04-14 | reduction in hypotension: 19%; hypotension GTx 104: 28%; hypotension nimodipine: 35%; RDI 95 percent or higher GTx 104: 54%; RDI 95 percent or higher nimodipine: 8%; favorable outcomes increase: 29% Read More | Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026 Read More | |
GTx-104 Orphan | aneurysmal subarachnoid hemorrhage (aSAH) | Phase 3 | 2026-04-14 | reduction in hypotension: 19%; hypotension GTx 104: 28%; hypotension nimodipine: 35%; RDI 95 percent or higher GTx 104: 54%; RDI 95 percent or higher nimodipine: 8%; favorable outcomes increase: 29% Read More | Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026 Read More | |
GTx-104 Orphan | aneurysmal subarachnoid hemorrhage (aSAH) | Phase 3 | 2026-04-14 | reduction in hypotension: 19%; hypotension GTx 104: 28%; hypotension nimodipine: 35%; RDI 95 percent or higher GTx 104: 54%; RDI 95 percent or higher nimodipine: 8%; favorable outcomes increase: 29% Read More | Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026 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 GRCE
| 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 |
GRCE 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 | |
| 2026-08-21 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-08-21 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-08-21 | 0 | 0.00 | 0 | 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
GRCE▲ +7.2%on this news
Grace Therapeutics Announces 2026 Fiscal Year-End Financial Results, Provides Business Update
Grace Therapeutics reported its fiscal year-end results for 2026, focusing on GTx-104, an injectable formulation of nimodipine for aSAH. The company is preparing to resubmit its NDA following a Complete Response Letter from the FDA. Positive Phase 3 trial results were shared at major conferences, and the company holds multiple patents for GTx-104. Despite a decrease in net loss, financial challenges remain as cash reserves have diminished.
Read more →GRCE▲ +7.2%on this newsshared move
Corporate Presentation June 2026 Summary 2 Forward Looking Statements Statements in this presentation that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of th
Grace Therapeutics, Inc. presented findings related to its GTx-104 drug candidate, a novel intravenous formulation aimed at treating patients with aneurysmal subarachnoid hemorrhage (aSAH). A pivotal Phase 3 safety trial demonstrated its effectiveness compared to current oral nimodipine treatments. However, the company received an FDA Complete Response Letter citing deficiencies in its chemistry, manufacturing, and controls data. A Type A meeting with the FDA is scheduled to seek clarity on the next steps for the drug's regulatory submission.
Read more →GRCE▼ -6.1%on this news
Corporate Presentation April 2026 Summary 2 Forward Looking Statements Statements in this presentation that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of t
Grace Therapeutics, Inc. presented forward-looking statements regarding their drug candidate GTx-104, aimed at treating acute brain injury due to aneurysmal subarachnoid hemorrhage (aSAH). The FDA issued a Complete Response Letter citing issues with the chemistry, manufacturing, and controls (CMC) data package. Despite these challenges, the company plans to resubmit its New Drug Application (NDA) after meetings with the FDA for clarification on the path forward. The drug is noted for its potential benefits compared to the oral formulation of nimodipine, particularly in addressing significant unmet medical needs.
Read more →GRCEGrace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104
Grace Therapeutics received a Complete Response Letter from the FDA regarding its New Drug Application for GTx-104, intended for treating aneurysmal subarachnoid hemorrhage. The letter cited issues related to Chemistry, Manufacturing, and Controls, but did not request additional clinical data. The company plans to address these issues and resubmit the application after a Type A meeting with the FDA.
Read more →GRCE▲ +12%on this news
Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026
Grace Therapeutics announced that an abstract detailing the results of the STRIVE-ON Phase 3 trial of GTx-104 has been accepted for presentation at the AAN 2026 meeting. The trial showed that GTx-104 significantly reduced episodes of clinically significant hypotension compared to oral nimodipine. Additionally, GTx-104 demonstrated better relative dose intensity and favorable functional outcomes at 90 days.
Read more →GRCEGrace Therapeutics to Present Data on the Unmet Medical Needs and Potential Benefits of GTx-104 in the Treatment of aSAH at Upcoming Medical Conferences
Grace Therapeutics is set to present data on GTx-104, an injectable formulation of nimodipine, at two major medical conferences in March 2026. The presentations will focus on the unmet medical needs in treating aneurysmal subarachnoid hemorrhage (aSAH) and the advantages of GTx-104 over oral nimodipine. Data from the Phase 3 STRIVE-ON Trial indicates that GTx-104 may improve patient outcomes and tolerability.
Read more →GRCEGrace Therapeutics to Participate in the TD Cowen 46th Annual Health Care Conference
Grace Therapeutics will participate in the TD Cowen 46th Annual Health Care Conference, with CEO Prashant Kohli presenting on March 4, 2026. The company is advancing GTx-104, an injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH). GTx-104 aims to address significant unmet medical needs in this patient population.
Read more →GRCEGrace Therapeutics Announces Third Quarter 2026 Financial Results, Provides Business Update
Grace Therapeutics reported its third quarter 2026 financial results, highlighting progress on its GTx-104 drug candidate for aneurysmal Subarachnoid Hemorrhage (aSAH). The FDA has set a PDUFA target date of April 23, 2026, for the review of GTx-104's NDA submission. The company also presented positive data from the Phase 3 STRIVE-ON trial, which demonstrated improved clinical outcomes for patients treated with GTx-104.
Read more →GRCEGrace Therapeutics to Participate in 16th Annual Craig-Hallum Alpha Select Conference
Grace Therapeutics, Inc. (Nasdaq: GRCE) has announced its participation in the 16th Annual Craig-Hallum Alpha Select Conference, scheduled for November 18, 2025. CEO Prashant Kohli will present at this invitation-only event, which showcases smaller public companies believed to have significant growth potential. The company is developing GTx-104, a novel intravenous formulation of nimodipine targeting unmet medical needs in patients with aneurysmal subarachnoid hemorrhage (aSAH), an uncommon but serious condition. GTx-104 has shown to be well tolerated in clinical studies, potentially offering better management of hypotension in aSAH patients.
Read more →GRCEGrace Therapeutics Announces Second Quarter 2026 Financial Results, Provides Business Update
Grace Therapeutics announced the FDA's acceptance of their NDA for GTx-104, aimed at treating aneurysmal Subarachnoid Hemorrhage (aSAH), with a PDUFA target date set for April 23, 2026. The company highlighted positive outcomes from the Phase 3 STRIVE-ON trial, which demonstrated improved clinical results for patients. Additionally, a new patent for the IV dosing regimen of GTx-104 was granted, enhancing their intellectual property portfolio.
Read more →GRCEGrace Therapeutics Announces Abstract Accepted for Presentation at Society of Vascular and Interventional Neurology Annual Meeting
Grace Therapeutics announced that an abstract for its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 has been accepted for presentation at the Society of Vascular and Interventional Neurology annual meeting. The trial focuses on treating aneurysmal subarachnoid hemorrhage (aSAH) with an innovative injectable formulation of nimodipine. The presentation will occur on November 21, 2025, in Orlando, FL.
Read more →GRCEGrace Therapeutics Secures Approximately $4.0 Million through Common Warrant Exercises Following Acceptance of New Drug Application for GTx-104 for formal FDA Review
Grace Therapeutics has raised approximately $4.0 million through common warrant exercises following the FDA's acceptance of their New Drug Application for GTx-104. This drug aims to treat patients with aneurysmal subarachnoid hemorrhage (aSAH) and is supported by positive results from a Phase 3 trial. The FDA has set a PDUFA target date for review on April 23, 2026.
Read more →GRCEGrace Therapeutics Pivotal Phase 3 STRIVE-ON Safety Trial Presented at 2025 Neurocritical Care Annual Meeting
Grace Therapeutics presented positive results from its Phase 3 STRIVE-ON Safety Trial for GTx-104 at the Neurocritical Care Society annual meeting. The trial demonstrated that GTx-104, an injectable formulation of nimodipine, is safe and well-tolerated in patients with aneurysmal subarachnoid hemorrhage (aSAH). The findings suggest it may outperform oral nimodipine in managing hypotension and improving patient outcomes.
Read more →GRCEGrace Therapeutics Granted Sixth U.S. Patent Covering I.V. Dosing Regimen for GTx-104
Grace Therapeutics has been granted a new U.S. patent for the intravenous dosing regimen of GTx-104, extending its protection until 2043. This patent complements the existing five patents on the composition of nimodipine, enhancing the company's market exclusivity. The STRIVE-ON safety trial demonstrated GTx-104's potential benefits over oral nimodipine, particularly in managing hypotension in aSAH patients.
Read more →GRCEGrace Therapeutics Announces Presentation at The H.C. Wainwright 27th Annual Global Investment Conference
Grace Therapeutics, a late-stage biopharma company, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025. The company will showcase its lead clinical asset, GTx-104, aimed at treating aneurysmal Subarachnoid Hemorrhage (aSAH). CEO Prashant Kohli will be available for one-on-one meetings with investors during the event.
Read more →GRCEGrace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104
Grace Therapeutics announced that the FDA has accepted its New Drug Application for GTx-104, intended for treating aneurysmal Subarachnoid Hemorrhage (aSAH). The application is backed by positive results from the Phase 3 STRIVE-ON safety trial. The FDA has set a PDUFA target date of April 23, 2026, for its review. GTx-104 aims to provide a novel treatment option for aSAH patients, addressing a long-standing gap in care.
Read more →GRCEGrace Therapeutics Announces First Quarter 2026 Financial Results, Provides Business Update Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for GTx-104 Seeking Approval of GTx-104 in t
Grace Therapeutics has announced its financial results for Q1 2026, highlighting the submission of a New Drug Application (NDA) for GTx-104, aimed at treating patients with aneurysmal Subarachnoid Hemorrhage (aSAH). This submission follows positive outcomes from the Phase 3 STRIVE-ON safety trial, which demonstrated improved clinical outcomes and met its primary endpoint. Despite reporting an increase in net losses, the company emphasizes the importance of this milestone as an innovation in a therapeutic area that hasn't seen significant advancements in years. The NDA submission symbolizes a promising step towards FDA approval, pending formal review.
Read more →GRCEGrace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104 Submission Seeks Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (
Grace Therapeutics has submitted a New Drug Application (NDA) to the U.S. FDA for GTx-104, aimed at treating patients with aneurysmal Subarachnoid Hemorrhage (aSAH). This submission follows encouraging results from the Phase 3 STRIVE-ON safety trial, showing clinical benefits of GTx-104 over the standard oral treatment. If approved, the NDA may unlock up to $7.6 million in financing. The company is optimistic about GTx-104's potential to innovate treatment options for aSAH patients after decades of stagnation in standard therapies.
Read more →GRCEGrace Therapeutics Announces 2025 Fiscal Year-End Results, Provides Business Update Held Type C meeting with FDA on Planned New Drug Application (NDA) Submission, Including Clinical, Non-clinical, and Chemistry, Manufact
Grace Therapeutics announced its fiscal year-end results for 2025, highlighting significant progress in its clinical and corporate goals, particularly the positive outcomes of the Phase 3 STRIVE-ON trial for GTx-104. The company has achieved alignment with the FDA regarding its planned NDA submission, expected in the first half of 2025. Additionally, they secured $15 million in upfront financing, supporting pre-commercial planning and potential product launch. However, the company reported a net loss of $9.6 million in the most recent fiscal year, alongside increased R&D expenses.
Read more →GRCEGrace Therapeutics to Participate in the 2025 BIO International Conference
Grace Therapeutics, Inc. (Nasdaq: GRCE) will have its CEO, Prashant Kohli, participate in the 2025 BIO International Conference in Boston, focusing on their GTx-104 product. GTx-104 is a novel, injectable formulation of nimodipine targeting aneurysmal subarachnoid hemorrhage (aSAH), a serious condition with significant unmet medical needs. The BIO convention is an influential biotechnology event, offering networking opportunities with leading figures in the life sciences. Grace Therapeutics aims to address the challenges in treatment delivery for aSAH patients through its innovative drug formulation.
Read more →GRCE▲ +9.1%on this news
Grace Therapeutics Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104 NDA Submission Anticipated Q2 Calendar 2025 Princeton, NJ
Grace Therapeutics has announced a productive alignment with the FDA regarding its planned New Drug Application (NDA) for GTx-104. This injectable formulation of nimodipine targets patients with aneurysmal subarachnoid hemorrhage (aSAH), presenting a potential solution for a condition with significant unmet medical needs. The company's recent Phase 3 STRIVE-ON safety trial demonstrated promising outcomes, including reduced hypotension and higher patient compliance. The NDA submission is anticipated for Q2 2025, pending FDA review.
Read more →GRCE▼ -12.5%on this news
Corporate Presentation March 2025 Summary 2 Forward Looking Statements Statements in this presentation that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of t
Grace Therapeutics has presented a corporate overview highlighting its GTx-104 drug candidate, which is positioned to address challenges associated with the existing oral form of nimodipine in treating aneurysmal subarachnoid hemorrhage (aSAH). The presentation outlined that GTx-104 met primary endpoints in its Phase 3 STRIVE-ON trial and emphasized its potential advantages, including improved bioavailability and fewer administration challenges. Looking ahead, the company anticipates filing a New Drug Application (NDA) for GTx-104 in the first half of 2025.
Read more →GRCE▼ -7.2%on this news
Grace Therapeutics to Participate in the TD Cowen 45th Annual Health Care Conference
Grace Therapeutics, Inc. (Nasdaq: GRCE) announced that CEO Prashant Kohli will participate in the TD Cowen 45th Annual Health Care Conference in Boston from March 3-5, 2025. The company is advancing GTx-104, a clinical-stage injectable formulation of nimodipine targeted at addressing unmet medical needs in patients suffering from aneurysmal subarachnoid hemorrhage (aSAH). The drug has shown promising results in previous trials and aims to improve delivery and management of treatment for this rare medical emergency.
Read more →GRCEGrace Therapeutics Announces Third Fiscal Quarter 2025 Financial Results, Provides Business Update Announced Phase 3 STRIVE-ON Safety Trial Met Primary Endpoint and Provided Clinical Benefit Compared to Orally Administer
Grace Therapeutics announced its third fiscal quarter 2025 financial results, highlighting the positive outcomes from the Phase 3 STRIVE-ON safety trial for GTx-104, which met its primary endpoint. The company also secured $15 million in upfront financing, potentially totaling $30 million, to support its ongoing development and planned NDA submission in the first half of 2025. However, the quarterly financial report revealed a significant net loss and a decrease in cash reserves. The results and financing are seen as critical steps toward addressing unmet medical needs in aSAH patients.
Read more →GRCE▲ +8.3%on this newsshared move
Grace Therapeutics Announces Private Placement Financing of up to $30 Million
Grace Therapeutics, Inc. has announced a private placement financing of up to $30 million, led by Nantahala Capital and ADAR1 Partners, along with other healthcare investors. The financing includes $15 million in upfront gross proceeds and an additional $15 million contingent on warrant exercises. The funds will be used for general corporate purposes and to advance the development of GTx-104, a novel injectable formulation of nimodipine aimed at treating patients with aneurysmal subarachnoid hemorrhage (aSAH). The placement is expected to close on February 11, 2025, subject to customary conditions.
Read more →GRCE▲ +8.3%on this newsshared move
Grace Therapeutics Announces Results From Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH Trial Met the Primary Endpoint and Provides Evidence of GTx-104 Clinical Benefit Compared to Orally Administered Nimodip
Grace Therapeutics has announced positive results from its Phase 3 STRIVE-ON safety trial for GTx-104, a novel injectable formulation of nimodipine for aSAH patients. The trial met its primary endpoint, showing a significant reduction in incidents of clinically significant hypotension compared to orally administered nimodipine. The company plans to submit a New Drug Application (NDA) in the first half of 2025 to advance GTx-104 in the treatment landscape. While the results are promising, some challenges, like a higher incidence of severe aSAH cases among GTx-104 patients, remain.
Read more →GRCEGrace Therapeutics to Participate in Upcoming Investor Events January 2025
Grace Therapeutics, previously known as Acasti Pharma, announced its participation in two key investor and industry networking events in January 2025. CEO Prashant Kohli will represent the company, emphasizing its focus on promoting GTx-104, an injectable formulation of nimodipine targeting aneurysmal subarachnoid hemorrhage (aSAH). The company aims to address significant unmet needs for patients suffering from this dangerous condition. GTx-104 shows potential in enhancing treatment delivery and efficacy in critical care settings.
Read more →GRCE▲ +20%on this news
Grace Therapeutics to Exhibit at the American Society of Health-System Pharmacists Conference
Grace Therapeutics, formerly known as Acasti Pharma, will exhibit at the American Society of Health-System Pharmacists (ASHP) conference in New Orleans from December 8-12, 2024. The company is focusing on its novel injectable formulation, GTx-104, aimed at treating aneurysmal subarachnoid hemorrhage (aSAH). CEO Prashant Kohli emphasized the need for enhanced treatment options for aSAH patients and the intent to educate pharmacists about the potential benefits of their new formulation. The company looks forward to sharing data from their Phase 3 STRIVE-ON trial in early 2025.
Read more →GRCEGrace Therapeutics Announces Second Fiscal Quarter 2025 Financial Results, Provides Business Update STRIVE-ON Data Readout Expected First Calendar Quarter 2025; NDA Submission on Track for 1H Calendar 2025 Completed Corp
Grace Therapeutics has announced its financial results for Q2 2025, showcasing significant progress with the completion of patient enrollment in its pivotal Phase 3 STRIVE-ON trial for GTx-104 and a planned NDA submission in the first half of 2025. The company also reported a net loss of $3.4 million, reflecting increased research and administrative costs. Furthermore, a virtual KOL event is scheduled for November 20, 2024, to highlight GTx-104's potential benefits for patients with aneurysmal subarachnoid hemorrhage. Grace Therapeutics has recently completed a corporate rebranding and is projected to have sufficient cash to support operations until mid-2026.
Read more →GRCEGrace Therapeutics to Host Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage on November 20, 2024
Grace Therapeutics is set to host a virtual key opinion leader (KOL) event on November 20, 2024, focusing on GTx-104, its injectable formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH). Experts Abhishek Ray, MD, and Andrew Webb, PharmD, will discuss the serious medical challenges in treating aSAH, which affects over 50,000 patients annually in the U.S. GTx-104 seeks to address significant gaps in current treatment methods and improve patient outcomes through its novel delivery method. The company emphasizes the clinical significance of advancing this therapy in a high-need area.
Read more →GRCEAcasti Announces Corporate Name Change to Grace Therapeutics, Inc. Name Change Reflects Extensive Scientific and Corporate Brand Equity Previously Established under Grace Therapeutics Grace Therapeutics will begin tradin
Acasti Pharma Inc. has announced a corporate name change to Grace Therapeutics, Inc., effective October 28, 2024. This change reflects the brand equity established prior to its merger with Acasti in 2021. The new branding aims to highlight the company's commitment to scientific innovation while advancing its lead drug candidate, GTx-104. The company also noted the successful enrollment in the STRIVE-ON trial and plans to submit a New Drug Application to the FDA in early 2025. Additionally, a Key Opinion Leader event regarding GTx-104 will take place on November 20, 2024.
Read more →GRCEAcasti Announces Completion of Patient Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial of GTX-104 Data Readout Expected Early Calendar 2025; NDA Submission on Track for 1H Calendar 2025 Princeton, NJ
Acasti Pharma Inc. announced the successful completion of patient enrollment in its Pivotal Phase 3 STRIVE-ON safety trial for GTX-104, a novel injectable formulation targeting aneurysmal subarachnoid hemorrhage (aSAH). The trial involves a comparison of GTX-104 to oral nimodipine in around 100 hospitalized patients across 25 U.S. hospitals. Data from the trial is expected to be released in early 2025, with plans for a New Drug Application submission to the FDA in the first half of that year.
Read more →GRCEACASTI PHARMA INC. Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) Three months ended
Acasti Pharma Inc. announced strong financial results for the first fiscal quarter of 2025, highlighting the surpassing of a 50% enrollment milestone in its pivotal Phase 3 STRIVE-ON trial for GTX-104. The company is on track for full patient enrollment by early 2025 and anticipates submitting a New Drug Application to the FDA in the first half of 2025. Despite a net loss of $2.6 million for the quarter, Acasti has a projected cash runway that extends into the second quarter of 2026, suggesting a stable financial outlook as it advances its clinical programs.
Read more →GRCEAcasti Announces Achievement of 50% Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial Company Anticipates Completion of Patient Enrollment in the STRIVE-ON Trial in Late 2024 to Early 2025, with Potential NDA Submissi
Acasti Pharma Inc. has reached a significant milestone by achieving 50% enrollment in its pivotal Phase 3 STRIVE-ON safety trial for GTX-104, an injectable treatment for aneurysmal subarachnoid hemorrhage (aSAH). The trial, which began in October 2023, aims to compare GTX-104 with oral nimodipine in patients suffering from aSAH. Company executives express optimism about completing enrollment by early 2025, while preparing for a potential NDA submission to the FDA in the first half of 2025. GTX-104 aims to offer an effective intravenous alternative for aSAH patients, particularly those with difficulties in oral medication administration.
Read more →GRCEACASTI PHARMA INC. Consolidated Statements of Operations and Comprehensive Loss Year ended
Acasti Pharma Inc. has reported its financial results for the year ended March 31, 2024, highlighting continued progress in its GTX-104 pivotal STRIVE-ON Phase 3 trial aimed at treating aneurysmal subarachnoid hemorrhage (aSAH). Patient enrollment is advancing well, with a potential NDA submission to the FDA anticipated in the first half of 2025. The company has improved its financial situation, reducing its net loss significantly compared to the previous year. With a projected cash runway extending into Q2 2026, Acasti aims to position itself favorably in addressing unmet medical needs.
Read more →GRCECompany Overview NASDAQ: ACST April 2024 Forward Looking Statements Statements in this presentation that are not statements of historical or current fact constitute forward-looking statements within the meaning of the U.
Acasti's GTX-104 is being developed as a novel intravenous treatment for aneurysmal subarachnoid hemorrhage (aSAH), potentially displacing the current oral standard of care. The company has initiated the Phase 3 STRIVE-ON trial and expects its cash runway to support trial activities and a potential NDA submission in 1H 2025. While there are promising advancements with GTX-104, challenges surrounding regulatory expectations and financial stability persist, which could impact the company's future delivery of clinical results.
Read more →GRCEAcasti Announces Third Fiscal Quarter 2024 Financial Results and Business Highlights • Projected Cash Runway Extends into Second Calendar Quarter 2026, Well Beyond Potential 1H 2025 Submission of GTX-104 New Drug
Acasti Pharma Inc. announced its financial results for the third fiscal quarter of 2024, highlighting significant developments for its drug candidate GTX-104. The company projects its cash runway to extend into the second calendar quarter of 2026, with progress in patient enrollment for the pivotal STRIVE-ON Phase 3 trial. A potential New Drug Application (NDA) submission for GTX-104 is anticipated in the first half of 2025, following a recent Key Opinion Leader event and a presentation at the 2024 International Stroke Conference. The company reported a net loss of $2.4 million for the quarter, showing a decrease from the previous year.
Read more →GRCEACASTI PHARMA INC. Condensed Consolidated Interim Statements of Loss and Comprehensive Loss (Unaudited) Three months ended Six months ended
Acasti Pharma Inc. recently announced its financial results and key developments for Q2 2024, emphasizing progress on its GTX-104 program. The company initiated the pivotal STRIVE-ON Phase 3 trial for GTX-104 and secured $7.5 million in private placement financing. The ongoing trial aims to position GTX-104 as a potential new treatment standard for aneurysmal subarachnoid hemorrhage (aSAH). Acasti also hosted a virtual webinar discussing the advantages of GTX-104 over oral nimodipine and further outlined its strategic direction.
Read more →GRCEin such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the planned Phase 3 safety trial for GTX-104; (ii)
Acasti Pharma has successfully dosed the first patient in its pivotal Phase 3 STRIVE-ON safety trial for GTX-104, aimed at addressing aSAH. The company has secured a recent $7.5 million private placement financing, which extends its financial runway to the first quarter of 2026. The expected New Drug Application (NDA) submission for GTX-104 is anticipated in the first half of 2025, contingent on the trial’s success. GTX-104 represents a novel intravenous formulation intended to meet high unmet medical needs in treating aneurysmal subarachnoid hemorrhage.
Read more →GRCEAcasti Announces $7.5 Million Private Placement Equity Financing Princeton, NJ
Acasti Pharma Inc. has successfully closed a private placement worth $7.5 million to support its clinical development of GTX-104, aimed at addressing the unmet medical needs of patients with aneurysmal subarachnoid hemorrhage (aSAH). The financing involved issuing common shares and warrants to various institutional and accredited investors, with gross proceeds expected to fund Phase 3 clinical trials and other corporate expenses. As regulatory and market conditions remain dynamic, Acasti plans to file for an initial registration statement with the SEC for the resale of the issued shares within 30 days.
Read more →GRCEAcasti Announces First Quarter 2024 Financial Results and Business Highlights • New leadership team singularly focused on executing GTX-104 strategy • Announced alignment with the U.S. Food and Drug Adminis
Acasti Pharma Inc. reported its first quarter 2024 financial results, highlighting a new leadership team focused on advancing the GTX-104 strategy. The company has aligned with the FDA for its pivotal STRIVE-ON Phase 3 safety trial, with the first patient expected to be dosed by the end of 2023. Acasti's cash and cash equivalents stand at $21.6 million, expected to fund operations through Q2 2025 and support potential submission of a New Drug Application (NDA) for GTX-104. Despite a net loss of $4 million for the quarter, the company reflects progress in its operational realignment efforts.
Read more →GRCEAcasti Pharma Announces 1-for-6 Reverse Stock Split LAVAL, Qu bec
Acasti Pharma Inc. has announced a 1-for-6 reverse stock split of its common shares effective July 10, 2023, as part of its strategy to meet NASDAQ minimum bid price requirements. This move will reduce the outstanding shares from approximately 44.6 million to 7.4 million. The company also highlighted its lead asset GTX-104, which targets aneurysmal subarachnoid hemorrhage and has received Orphan Drug Designation from the FDA. Acasti aims to enhance the performance of marketed drugs through innovative delivery technologies, despite facing regulatory and market uncertainties.
Read more →GRCEAcasti Announces Alignment with FDA on GTX-104 Pivotal Phase 3 Safety Trial Protocol and Confirms Planned Initiation of STRIVE-ON in aSAH Patients in Calendar Q4 2023 STRIVE-ON is the pivotal Phase 3 trial of GTX-104 to
Acasti Pharma has announced alignment with the FDA regarding the protocol for its pivotal Phase 3 safety trial of GTX-104, targeting aSAH patients. The STRIVE-ON trial will compare the safety and tolerability of GTX-104 to oral nimodipine in an estimated 100 patients. Following previous healthy volunteer studies demonstrating GTX-104's safety, Acasti is set to initiate the trial in Q4 2023, with a potential NDA submission anticipated by mid-2025. This novel formulation of nimodipine aims to address a significant unmet need in this patient population.
Read more →GRCEAcasti Pharma Reports Fiscal Year 2023 Operational Results LAVAL, Qu bec
Acasti Pharma has reported its fiscal year 2023 operational results, emphasizing a favorable update from the FDA regarding the GTX-104 drug pathway. Significant progress includes the submission of the Phase 3 Safety Study protocol, with patient dosing anticipated in late 2023. However, the company also reported a considerable financial loss and impairments due to strategic shifts, focusing solely on GTX-104 while de-prioritizing other pipeline assets. Acasti's current cash runway is projected to support operations through mid-2025.
Read more →GRCEAcasti Announces Appointment of Prashant Kohli as CEO LAVAL, Qu bec
Acasti Pharma Inc. has appointed Prashant Kohli as its new Chief Executive Officer, succeeding Jan D'Alvise. Kohli has served as Chief Commercial Officer since 2022 and has over 20 years of experience in commercialization and strategy. His leadership comes at a pivotal time as Acasti prepares to advance GTX-104, its drug candidate for Subarachnoid Hemorrhage, into a Phase 3 safety study. The company holds Orphan Drug Designation for multiple assets, highlighting its focus on rare and orphan diseases.
Read more →GRCEAcasti Pharma Inc. Centralizes Marketplace for Shares on the Nasdaq with Voluntary Delisting from TSX Venture Exchange Acasti also confirms no exposure to Silicon Valley Bank (“SVB”) or Silvergate Bank LAVA
Acasti Pharma Inc. has announced the voluntary delisting of its common shares from the TSX Venture Exchange, aiming to centralize trading on the NASDAQ. The delisting is anticipated to enhance the liquidity and value for shareholders. Acasti has confirmed that it holds no financial exposure to Silicon Valley Bank or Silvergate Bank. The company continues to advance three drug candidates targeting rare diseases, each with Orphan Drug Designation from the FDA.
Read more →GRCEAcasti Pharma Reports Third Quarter 2023 Operational Results Company to Host Conference Call Today at 1:00pm ET LAVAL, Qu bec
Acasti Pharma has announced its operational results for Q3 2023, highlighting significant progress in its clinical programs, specifically for GTX-104, GTX-102, and GTX-101. The company awaits FDA guidance, which could allow the initiation of Phase 3 studies for GTX-104, targeting aSAH patients. Moreover, GTX-102 has shown positive results in a PK study, intended to address neurological symptoms in children with Ataxia Telangiectasia, while GTX-101 is progressing along its regulatory pathway. Acasti's financial position remains robust, with enough capital projected to sustain operations until mid-2024.
Read more →GRCEAcasti Pharma Reports Second Quarter 2023 Operational Results Company to Host Conference Call Today at 1:00pm ET LAVAL, Qu bec
Acasti Pharma Reports Second Quarter 2023 Operational Results Company to Host Conference Call Today at 1:00pm ET LAVAL, Qu bec, November 14, 2022 -- Acasti Pharma Inc. ( Acasti or the Company ) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing thr
Read more →GRCEAcasti Announces Court Dismissal of Stockholder Litigation LAVAL, Qu bec
Acasti Announces Court Dismissal of Stockholder Litigation LAVAL, Qu bec, Sept. 30, 2022 (GLOBENEWSWIRE) Acasti Pharma Inc. ( Acasti or the Company ) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing
Read more →GRCEDATED SEPTEMBER 29, 2022 ANNOUNCING VOTING RESULTS OF ANNUAL AND SPECIAL MEETING EX-99.1 Acasti Announces Voting Results from 2022 Annual and Special Meeting of Shareholders Laval, Qu bec, CANADA
Acasti Announces Voting Results from 2022 Annual and Special Meeting of Shareholders Laval, Qu bec, CANADA, September 29, 2022 Acasti Pharma Inc. ( Acasti or the Company ) (NASDAQ: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug
Read more →GRCEAcasti Pharma Reports First Quarter 2023 Operational Results Company to Host Conference Call Today at 1:00pm ET LAVAL, Qu bec
Acasti Pharma Reports First Quarter 2023 Operational Results Company to Host Conference Call Today at 1:00pm ET LAVAL, Qu bec, August 11, 2022 -- Acasti Pharma Inc. ( Acasti or the Company ) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company with drug delive
Read more →GRCEAcasti Pharma Reports Fiscal Year 2022 Operational Results Company to Host Conference Call Today at 1:00pm ET For Immediate Release LAVAL, Qu bec
Acasti Pharma Reports Fiscal Year 2022 Operational Results Company to Host Conference Call Today at 1:00pm ET LAVAL, Qu bec, June 21, 2022 (PR NEWSWIRE) -- Acasti Pharma Inc. ( Acasti or the Company ) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company with d
Read more →GRCEACASTI PHARMA ANNOUNCES POSITIVE RESULTS FOR PHARMACOKINETIC BRIDGING STUDY, WITH INTRAVENOUS GTX-104 MEETING ALL ENDPOINTS Bioavailability of IV GTX-104 compared favorably with the oral formulation of nimodipine, and no
ACASTI PHARMA ANNOUNCES POSITIVE RESULTS FOR PHARMACOKINETIC BRIDGING STUDY, WITH INTRAVENOUS GTX-104 MEETING ALL ENDPOINTS Bioavailability of IV GTX-104 compared favorably with the oral formulation of nimodipine, and no serious adverse events observed for GTX-104 Phase 3 remai
Read more →GRCEAcasti Pharma Appoints Healthcare Industry Leader Michael L. Derby to its Board of Directors LAVAL, Qu bec
Acasti Pharma Appoints Healthcare Industry Leader Michael L. Derby to its Board of Directors LAVAL, Qu bec, March 25, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ( Acasti or the Company ) (Nasdaq: ACST and TSX-V: ACST) today announces that it has appointed Michael L. Derby to it
Read more →GRCEAcasti Pharma Provides Business Update for the Third Quarter of Fiscal 2022 Provides updates on key milestones: GTX-104 PK study remains on track for results to be reported in the first half of calendar 2022; GTX-102 and
Acasti Pharma Provides Business Update for the Third Quarter of Fiscal 2022 Provides updates on key milestones: GTX-104 PK study remains on track for results to be reported in the first half of calendar 2022; GTX-102 and GTX-101 progressing on schedule Conference call to be hel
Read more →GRCEAcasti Pharma Announces Interim Data Meets All Primary Endpoints for Pivotal PK Study for GTX-104
Acasti Pharma Announces Interim Data Meets All Primary Endpoints for Pivotal PK Study for GTX-104 Bioavailability of GTX-104 compares favorably with the oral formulation of nimodipine; full PK study expected to report out as planned in H1'22 LAVAL, Qu bec, Dec. 02, 2021 (GLOBE
Read more →GRCEAcasti Pharma Announces Annual Stock Option Grants
Acasti Pharma Announces Annual Stock Option Grants LAVAL, Qu bec, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST and TSX-V: ACST), today announced the annual grant of stock options to its employees, executives and directors. An ag
Read more →GRCEAcasti Pharma Provides Business Update for the Second Quarter of Fiscal 2022
Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2022 Conference call to be held on Wednesday, November 10th at 1:00 p.m. ET LAVAL, Qu bec, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST and TSX-V: ACST), to
Read more →GRCEAcasti Pharma Provides Update Following Acquisition of Grace Therapeutics and Regains Compliance with Nasdaq Listing Standards
Acasti Pharma Provides Update Following Acquisition of Grace Therapeutics and Regains Compliance with Nasdaq Listing Standards LAVAL, Qu bec, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST and TSX-V: ACST), today provided a busine
Read more →GRCEAcasti Pharma Provides Business Update for the First Quarter of Fiscal 2022
Acasti Pharma Provides Business Update for the First Quarter of Fiscal 2022 August 4th webcast replay discussing planned acquisition of Grace Therapeutics available on the Company's website Shareholders urged to vote in advance of upcoming shareholder meeting on August 26th LA
Read more →GRCEAcasti Pharma Provides Fiscal 2021 Year-End Business Update
Acasti Pharma Provides Fiscal 2021 Year-End Business Update Update on Acquisition of Grace Therapeutics and Strategic Plans for CaPre LAVAL, Qu bec, June 22, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST and TSX-V: ACST) today announced i
Read more →GRCEAcasti Intends to Request Hearing Before Nasdaq Panel to Present Plan of Compliance
Acasti Intends to Request Hearing Before Nasdaq Panel to Present Plan of Compliance LAVAL, Qu bec, May 17, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST and TSX-V: ACST) today announced that, on May 11, 2021, the Company received notice fr
Read more →GRCELOCK-UP AGREEMENT (this "Agreement") is entered into as of May 7, 2021 by and between Acasti Pharma Inc.,
LOCK-UP AGREEMENT (this "Agreement") is entered into as of May 7, 2021 by and between Acasti Pharma Inc., a corporation incorporated under the Business Corporations Act (Qu bec) ("Acasti"), the undersigned stockholder (the "Stockholder") of Grace Therapeutics, Inc., a corporati
Read more →GRCEAcasti Pharma Provides Update on Recent Financing Activities
Acasti Pharma Provides Update on Recent Financing Activities LAVAL, Quebec, March 08, 2021 (GLOBE NEWSWIRE) -- As required pursuant to the policies of the TSX Venture Exchange, Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ: ACST - TSX-V: ACST) is providing an update on t
Read more →GRCEAcasti Pharma Announces Results for Third Quarter of Fiscal 2021
Acasti Pharma Announces Results for Third Quarter of Fiscal 2021 LAVAL, Quebec, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ: ACST - TSX-V: ACST) today announced its operating and financial results for the third quarter of fiscal 2021 e
Read more →GRCEAcasti Pharma Provides Business Update for the Second Quarter of Fiscal 2021
Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2021 LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ: ACST - TSX-V: ACST) today provided a business update and announced its operating and financial res
Read more →GRCEIn this By-law, and all other By-laws of the Corporation, unless
GENERAL BY-LAW 2020-1 1 - DEFINITIONS 1 1.1 Definitions 1 1.2 Interpretation 1 1.3 Execution in Counterpart, by Facsimile and by Electronic Signature 1 2 - GENERAL BUSINESS 2 2.1 Head Office 2 2.2 Establishment 2 2.3 Seal 2 2.4 Fiscal Year 2 2.5 Execution of Instruments 2 2.6 Ba
Read more →GRCEAcasti Announces Review Process of Strategic Alternatives
Acasti Announces Review Process of Strategic Alternatives Additional analyses of TRILOGY data underway LAVAL, Qu bec, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST - TSX-V: ACST) announces the Company has commenced a formal proc
Read more →GRCEAcasti Appoints Seasoned Executive Brian D.
Acasti Appoints Seasoned Executive Brian D. Ford CPA-CA as Chief Financial Officer LAVAL, Qu bec, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST - TSX-V: ACST) announced that it has appointed seasoned financial executive Brian D.
Read more →GRCEAcasti Announces Filing and Mailing of Information Circular and Change in Record Date
Acasti Announces Filing and Mailing of Information Circular and Change in Record Date LAVAL, Qu bec, Sept. 11, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST - TSX-V: ACST) announced that it has filed and mailed the information circular and
Read more →GRCEAcasti Pharma Reports Topline Triglyceride Results from Phase 3 TRILOGY 2 Study of CaPre in Patients with Severe Hypertriglyceridemia
Acasti Pharma Reports Topline Triglyceride Results from Phase 3 TRILOGY 2 Study of CaPre in Patients with Severe Hypertriglyceridemia CaPre achieved a 30.4% median reduction in triglycerides at 12 weeks and 38.4% at 26 weeks, but did not achieve statistical significance for the
Read more →GRCEAcasti Pharma Provides Business Update for the First Quarter of Fiscal 2021
Acasti Pharma Provides Business Update for the First Quarter of Fiscal 2021 On track to report TRILOGY 2 topline data on or about August 31, 2020 LAVAL, Qu bec, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ: ACST - TSX-V: ACST), a bioph
Read more →GRCEAcasti Pharma Submits Statistical Analysis Plan to FDA and Remains On Track to Report TRILOGY 2 Topline Data On or About August 31, 2020
Acasti Pharma Submits Statistical Analysis Plan to FDA and Remains On Track to Report TRILOGY 2 Topline Data On or About August 31, 2020 LAVAL, Qu bec, July 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ: ACST - TSX-V: ACST), a biopharmaceutic
Read more →GRCEAcasti Pharma Receives FDA Response to TRILOGY 1 Briefing Package
Acasti Pharma Receives FDA Response to TRILOGY 1 Briefing Package Plans to report summary of Trilogy 1 data on June 29, 2020 conference call LAVAL, Qu bec, June 19, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST - TSX-V: ACST), a biopharma
Read more →GRCESPECIAL MEETING OF SHAREHOLDERS
NOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS To the shareholders of Acasti Pharma Inc. (the "Corporation"): NOTICE IS HEREBY GIVEN THAT that the annual and special meeting of the shareholders (the "Meeting") of the Corporation will be held at the Giuseppe Saputo meeti
Read more →GRCEMANAGEMENT'S DISCUSSION AND ANALYSIS OF THE FINANCIAL SITUATION
MANAGEMENT'S DISCUSSION AND ANALYSIS OF THE FINANCIAL SITUATION AND OPERATING RESULTS - FOR THE THREE AND NINE - MONTH PERIODS ENDED DECEMBER 31, 2018 AND 2017 This management's discussion and analysis ("MD&A") is presented in order to provide the reader with an overview of th
Read more →GRCECORRECTION: Acasti Pharma Grants Stock Options Laval, Qu bec, CANADA
CORRECTION: Acasti Pharma Grants Stock Options Laval, Qu bec, CANADA - June 16, 2017 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:ACST), today announced the correction of its stock option grant announcement made on June 14, 2017. It was previously st
Read more →GRCEAcasti Pharma Grants Stock Options Laval, Qu bec, CANADA
Acasti Pharma Grants Stock Options Laval, Qu bec, CANADA - June 14, 2017 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:ACST.V), today announced the grant of an aggregate of 1,021,500 stock options to its employees, executives and members of the Board
Read more →GRCEAcasti Pharma To Present at Upcoming International Industry Conferences Laval, Qu bec, CANADA
Acasti Pharma To Present at Upcoming International Industry Conferences Laval, Qu bec, CANADA - June 12, 2016 - Acasti Pharma Inc. (NASDAQ: ACST - TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of CaPre (omega-3 phospholipi
Read more →GRCEAcasti Pharma Reports Fourth Quarter and Full-Year 2017 Financial Results Company Achieves Multiple Milestones to Advance Drug Candidate CaPre Towards Phase 3 Trials Laval, Qu bec, CANADA
Acasti Pharma Reports Fourth Quarter and Full-Year 2017 Financial Results Company Achieves Multiple Milestones to Advance Drug Candidate CaPre Towards Phase 3 Trials Laval, Qu bec, CANADA, June 6, 2017 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST) today announced its operatin
Read more →GRCEMANAGEMENT DISCUSSION AND ANALYSIS OF THE FINANCIAL SITUATION AND OPERATING RESULTS - THIRTEEN-MONTH AND ONE-MONTH PERIODS ENDED MARCH 31, 2017, TWELVE-MONTH PERIOD ENDED FEBRUARY 28, 2017 AND YEARS ENDED FEBRUARY 29, 20
MANAGEMENT DISCUSSION AND ANALYSIS OF THE FINANCIAL SITUATION AND OPERATING RESULTS - THIRTEEN-MONTH AND ONE-MONTH PERIODS ENDED MARCH 31, 2017, TWELVE-MONTH PERIOD ENDED FEBRUARY 28, 2017 AND YEARS ENDED FEBRUARY 29, 2016 AND FEBRUARY 28, 2015 This management's discussion and a
Read more →GRCEAcasti Pharma and CordenPharma Announce Large Scale Production of CaPre with New Continuous Manufacturing Process Laval, Qu bec, CANADA
Acasti Pharma and CordenPharma Announce Large Scale Production of CaPre with New Continuous Manufacturing Process Laval, Qu bec, CANADA - May 31, 2017 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST) today announced the achievement of a major corporate milestone by manufacturing
Read more →GRCEAcasti Pharma Presents CaPre Clinical Data at National Lipid Association Scientific Sessions Laval, Qu bec, CANADA
Acasti Pharma Presents CaPre Clinical Data at National Lipid Association Scientific Sessions Laval, Qu bec, CANADA - May 18, 2017 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST) today announced the presentation of the CaPre (omega-3 phospholipid) bridging study results at the up
Read more →GRCEAcasti Granted Additional Composition & Use Patents in Taiwan and Australia; Safeguards Valuable Market Expansion Opportunities LAVAL, Qu bec
Acasti Granted Additional Composition & Use Patents in Taiwan and Australia; Safeguards Valuable Market Expansion Opportunities LAVAL, Qu bec, April 24, 2017 -- Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST), a biopharmaceutical innovator focused on the research, development and
Read more →GRCEAcasti Pharma to Present CaPre Omega-3 Bridging Study Results at National Lipid Association Scientific Sessions Laval, Qu bec, CANADA
Acasti Pharma to Present CaPre Omega-3 Bridging Study Results at National Lipid Association Scientific Sessions Laval, Qu bec, CANADA - April 12, 2017 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST) today announced that company researchers have been invited to present the CaPre
Read more →GRCEAcasti Pharma Provides Update On CaPre Phase 3 Development Program Outcome of the End-of-Phase 2 Meeting with the FDA Confirms Phase 3 Program is on Track to Start Late 2017 Laval, Qu bec, CANADA
Acasti Pharma Provides Update On CaPre Phase 3 Development Program Outcome of the End-of-Phase 2 Meeting with the FDA Confirms Phase 3 Program is on Track to Start Late 2017 Laval, Qu bec, CANADA - March 30, 2017 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST) today announced
Read more →GRCEAcasti Pharma Forms Scientific Advisory Board and Appoints Two Leading Cardiovascular Disease Experts Laval, Qu bec, CANADA
Acasti Pharma Forms Scientific Advisory Board and Appoints Two Leading Cardiovascular Disease Experts Laval, Qu bec, CANADA - March 8, 2017 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST) today announced the appointment of Barry A. Franklin, Ph.D. and Robert Hegele, M.D. to its
Read more →GRCEAcasti Pharma Grants Incentive Stock and Options Laval, Qu bec, CANADA
Acasti Pharma Grants Incentive Stock and Options Laval, Qu bec, CANADA - February 24, 2017 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:ACST.V), today announced the grant of an aggregate of 100,000 incentive stock options under the Corporation's Stoc
Read more →GRCENOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES Acasti Pharma Announces Closings of Concurrent Public Offering of Units and Private Placement of Convertible Debentures and Warrant
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES Acasti Pharma Announces Closings of Concurrent Public Offering of Units and Private Placement of Convertible Debentures and Warrants Laval, Qu bec, CANADA - February 21, 2017 - Acasti Phar
Read more →GRCEGENERAL BY-LAW OF ACASTI PHARMA INC. (the Corporation ) TABLE OF CONTENTS 1 - DEFINITIONS 1 1.1 Definitions 1 1.2 Interpretation 1 1.3 Execution in Counterpart, by Facsimile and by Electronic Signature 2 2 - GENERAL BUSI
1 - DEFINITIONS 1 1.1 Definitions 1 1.2 Interpretation 1 1.3 Execution in Counterpart, by Facsimile and by Electronic Signature 2 2 - GENERAL BUSINESS 2 2.1 Head Office 2 2.2 Establishment 2 2.3 Seal 2 2.4 Fiscal Year 2 2.5 Execu
Read more →GRCEAcasti Pharma Reports Third Quarter 2017 Financial Results Key Developments Include Advancement of Drug Candidate CaPre and New CFO Laval, Qu bec, CANADA
Acasti Pharma Reports Third Quarter 2017 Financial Results Key Developments Include Advancement of Drug Candidate CaPre and New CFO Laval, Qu bec, CANADA, January 12, 2017 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ/TSX-V:ACST) today announced its operating and
Read more →GRCEBUSINESS DESCRIPTION OF, AND RISK FACTORS RELATING TO, ACASTI PHARMA INC. Dated as of
BUSINESS DESCRIPTION OF, RISK FACTORS RELATING TO, Dated as of December 5, 2016 In this document, unless the context otherwise requires, references to Acasti , the Corporation , we , us , it , its or similar terms refer to Acasti Pharma Inc. and references to Neptune refer to
Read more →GRCEAcasti Pharma Appoints Linda O'Keefe as Chief Financial Officer Laval, Qu bec, CANADA
Acasti Pharma Appoints Linda O'Keefe as Chief Financial Officer Laval, Qu bec, CANADA - November 28, 2016 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:ACST) today announced that Linda O'Keefe has been named chief financial officer. Ms. O'Keefe brings to Acasti over 30 years of fina
Read more →GRCESOURCE: Acasti Pharma Inc. Acasti Announces Stock Ticker Symbol Change to ACST on the TSXV Laval, Qu bec, CANADA
SOURCE: Acasti Pharma Inc. Acasti Announces Stock Ticker Symbol Change to ACST on the TSXV Laval, Qu bec, CANADA - November 3, 2016 - Acasti Pharma Inc. (NASDAQ:ACST - TSX-V:APO), today announced that as a result of the recent introduction of four-letter root symbols on the TSX
Read more →GRCEAcasti Pharma Builds Intellectual Property Portfolio with Newly Issued U.S. Patent for CaPre Laval, Qu bec, CANADA
Acasti Pharma Builds Intellectual Property Portfolio with Newly Issued U.S. Patent for CaPre Laval, Qu bec, CANADA, October 26, 2016 - Acasti Pharma (NASDAQ:ACST - TSX-V:APO) today announced that the United States Patent and Trademark Office issued Acasti a patent (U.S. patent n
Read more →GRCEAcasti Pharma Reports Second Quarter 2017 Financial Results Key Developments Include New Leadership and Advancement of Drug Candidate CaPre Laval, Qu bec, CANADA
Acasti Pharma Reports Second Quarter 2017 Financial Results Key Developments Include New Leadership and Advancement of Drug Candidate CaPre Laval, Qu bec, CANADA, October 11, 2016 - Acasti Pharma (NASDAQ:ACST - TSX-V:APO) today announced its operating and financial results for
Read more →GRCEAcasti Pharma Reports Positive CaPre Omega-3 Bridging Study Data Results Support Streamlined Regulatory Pathway for Novel Hypertriglyceridemia Drug Laval, Qu bec, CANADA
Acasti Pharma Reports Positive CaPre Omega-3 Bridging Study Data Results Support Streamlined Regulatory Pathway for Novel Hypertriglyceridemia Drug Laval, Qu bec, CANADA, Sept. 14, 2016 - Acasti Pharma (NASDAQ:ACST - TSX-V:APO) today announced that its bridging study for novel
Read more →GRCENOTICE OF CHANGE IN FISCAL YEAR END Section 4.8 of National Instrument 51-102 TO: Autorit des march s financiers Alberta Securities Commission British Columbia Securities Commission Manitoba Securities Commission Ontario
NOTICE OF CHANGE IN FISCAL YEAR END Section 4.8 of National Instrument 51-102 TO: Autorit des march s financiers Alberta Securities Commission British Columbia Securities Commission Manitoba Securities Commission Ontario Securities Commission This Notice is provided pursua
Read more →GRCESOURCE: Acasti Pharma Inc. Acasti Announces the Election of its Directors, Change of Fiscal Year End and Other Related Matters Passed at its AGM Montr al, Qu bec, Canada
PRESS RELEASE SOURCE: Acasti Pharma Inc. Acasti Announces the Election of its Directors, Change of Fiscal Year End and Other Related Matters Passed at its AGM Montr al, Qu bec, Canada - July 15, 2016 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:
Read more →GRCENOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS To the shareholders of Acasti Phama Inc. (the " Corporation "): NOTICE IS HEREBY GIVEN THAT that the annual and special meeting of the shareholders (the " Meeting ") o
NOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS To the shareholders of Acasti Phama Inc. (the "Corporation"): NOTICE IS HEREBY GIVEN THAT that the annual and special meeting of the shareholders (the "Meeting") of the Corporation will be held at the McCord Museum, located a
Read more →GRCESOURCE: Acasti Pharma Inc. Acasti Announces Grant of Stock Options Laval, Qu bec, CANADA
SOURCE: Acasti Pharma Inc. Acasti Announces Grant of Stock Options Laval, Qu bec, CANADA - May 30, 2016 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercializati
Read more →GRCEMANAGEMENT DISCUSSION AND ANALYSIS OF THE FINANCIAL SITUATION AND OPERATING RESULTS - YEARS ENDED FEBRUARY 29, 2016 AND FEBRUARY 28, 2015 AND 2014 Introduction This management discussion and analysis ("MD&A") is presente
MANAGEMENT DISCUSSION AND ANALYSIS OF THE FINANCIAL SITUATION AND OPERATING RESULTS - YEARS ENDED FEBRUARY 29, 2016 AND FEBRUARY 28, 2015 AND 2014 This management discussion and analysis ("MD&A") is presented in order to provide the reader with an overview of the financial resul
Read more →GRCESOURCE: Acasti Pharma Inc. Acasti Announces Fourth Quarter and Fiscal Year Results Laval, Qu bec, CANADA
PRESS RELEASE SOURCE: Acasti Pharma Inc. Acasti Announces Fourth Quarter and Fiscal Year Results Laval, Qu bec, CANADA - May 25, 2016 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:APO), an emerging biopharmaceutical company focused on the research,
Read more →GRCESOURCE: Acasti Pharma Inc. Jan D'Alvise Appointed President & CEO of Acasti Pharma Seasoned Executive in Drug Development Laval, Qu bec, CANADA
SOURCE: Acasti Pharma Inc. Jan D'Alvise Appointed President & CEO of Acasti Pharma Seasoned Executive in Drug Development Laval, Qu bec, CANADA - May 12, 2016 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:APO), an emerging biopharmaceutical company
Read more →GRCESOURCE: Acasti Pharma Inc. Nasdaq Grants Acasti Cure Period to Regain Compliance with Audit Committee Membership Requirements Laval, Qu bec, CANADA - March 25 2016 - Acasti Pharma Inc. (" Acasti " or the "
SOURCE: Acasti Pharma Inc. Nasdaq Grants Acasti Cure Period to Regain Compliance with Audit Committee Membership Requirements Laval, Qu bec, CANADA - March 25 2016 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:APO), an emerging biopharmaceutical comp
Read more →GRCESOURCE: Acasti Pharma Inc. Acasti Announces Management Appointment and Changes to the Board of Directors Laval, Qu bec, CANADA
SOURCE: Acasti Pharma Inc. Acasti Announces Management Appointment and Changes to the Board of Directors Laval, Qu bec, CANADA - March 1, 2016 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:APO), an emerging biopharmaceutical company focused on the re
Read more →GRCESOURCE: Acasti Pharma Inc. Acasti Announces Share-for-Debt Laval, Qu bec, CANADA
SOURCE: Acasti Pharma Inc. Acasti Announces Share-for-Debt Laval, Qu bec, CANADA - February 5, 2016 - Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST - TSX-V:APO), an emerging biopharmaceutical company focused on the research, development and commercialization o
Read more →GRCENOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS
NOTICE OF ANNUAL AND SPECIAL MEETING OF SHAREHOLDERS To the shareholders of Acasti Phama Inc. (the "Corporation"): NOTICE IS HEREBY GIVEN THAT that the annual and special meeting of the shareholders (the "Meeting") of the Corporation will be held at Hotel Hilton Garden Inn, 380
Read more →GRCEANNUAL INFORMATION FORM Fiscal Year Ended
ANNUAL INFORMATION FORM Fiscal Year Ended February 28, 2014 Basis of Presentation 1 Cautionary Note Regarding Forward-Looking Information 1 Corporate Structure 3 Company Overview 3 Intercorporate Relationships 3 Acasti s Business 3 Business Strategy 4 Treat
Read more →GRCESOURCE: Neptune Technologies & Bioressources Inc., Acasti Pharma Inc. and NeuroBioPharm Inc. Neptune, Acasti and NeuroBioPharm Announce Litigation Regarding its Former Chief Executive Officer Laval, Qu bec,
SOURCE: Neptune Technologies & Bioressources Inc., Acasti Pharma Inc. and NeuroBioPharm Inc. Neptune, Acasti and NeuroBioPharm Announce Litigation Regarding its Former Chief Executive Officer Laval, Qu bec, CANADA May 30, 2014 Neptune Technologies & Bioressources Inc. ( Neptun
Read more →GRCEEXECUTION VERSION ACASTI PHARMA INC. as the Corporation and COMPUTERSHARE TRUST COMPANY OF CANADA as the Warrant Agent WARRANT INDENTURE Providing for the Issue of Warrants Dated as of
TRUST COMPANY OF CANADA as the Warrant Agent Providing for the Issue of Warrants Dated as of December 3, 2013 ARTICLE 1 INTERPRETATION 2 1.1 Definitions. 2 1.2 Gender and Number. 5 1.3 Headings, Etc. 5 1.4 Day not a Business Day. 6 1.5 Time of the Essence.
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UNDERWRITING AGREEMENT Euro Pacific Canada Inc. As Representative of the several Underwriters 130 King Street West, Suite 2820 Attention: Mr. Xavier Harland Chief Financial Officer Pacific Canada Inc. (the Representative ) and National Securities Corporation (collectively
Read more →GRCETHIS PREPAYMENT AGREEMENT is made on
THIS PREPAYMENT AGREEMENT is made on December 4, 2012 TECHNOLOGIES & BIORESSOURCES INC., a corporation governed by the laws of Quebec, a corporation governed by the laws of Quebec, THEREFORE, the Parties agree as follows: AND PRINCIPLES OF INTERPRETATION PREPAYMENT OF ROYALT
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