FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Supported by Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 PRINCETON, N.J., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage,... Read More

Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for GTx-104 Seeking Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) NDA Supported by Data from Phase 3 STRIVE-ON Safety Trial, which Met Primary Endpoint and Provided Evidence of Clinical Benefit Compared to Orally Administered Nimodipine PRINCETON, N.J., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Grace... Read More

Submission Seeks Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Includes Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 Submission Has the Potential to Trigger Exercise of up to $7.6 million in Gross Proceeds from 2023 Financing Warrants Tied to FDA Acceptance of NDA for Review PRINCETON, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Grace... Read More

Held Type C meeting with FDA on Planned New Drug Application (NDA) Submission, Including Clinical, Non-clinical, and Chemistry, Manufacturing, and Control (CMC) Requirements NDA On Track for Submission to FDA in First Half of Calendar 2025 NDA to be Supported by Data from Phase 3 STRIVE-ON Safety Trial, which Met Primary Endpoint and Provided Evidence of Clinical Benefit Compared to Orally Administered Nimodipine Secured... Read More

PRINCETON, N.J., June 13, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that Chief Executive Officer Prashant... Read More

PRINCETON, N.J., April 09, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced details of the Company’s Type C meeting... Read More

PRINCETON, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that Chief... Read More

Announced Phase 3 STRIVE-ON Safety Trial Met Primary Endpoint and Provided Clinical Benefit Compared to Orally Administered Nimodipine; New Drug Application (NDA) Submission Anticipated First Half of Calendar 2025 Secured Private Placement Financing of $15 Million in Upfront Gross Proceeds with the Potential to Receive up to an Additional $15 Million in Potential Warrant Exercise Proceeds for an Aggregate of Up to... Read More

Financing led by Nantahala Capital and ADAR1 Partners, LP with participation from new and existing healthcare-focused institutional investors $15 million in upfront gross proceeds with the potential to receive up to an additional $15 million in potential warrant exercise proceeds for an aggregate of up to approximately $30 million in potential total gross proceeds PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Grace... Read More

Trial Met the Primary Endpoint and Provides Evidence of GTx-104 Clinical Benefit Compared to Orally Administered Nimodipine New Drug Application (NDA) Submission Expected in the First Half of 2025 PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE), formerly Acasti Pharma Inc. (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage,... Read More

PRINCETON, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Nasdaq: ACST) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs,... Read More

PRINCETON, N.J., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Nasdaq: ACST) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs,... Read More

STRIVE-ON Data Readout Expected First Calendar Quarter 2025; NDA Submission on Track for 1H Calendar 2025 Completed Corporate Re-Branding, Connecting Company to Rich Scientific Legacy of Grace Therapeutics Announced Completion of Patient Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 Hosting Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage November 20, 2024 Projected Cash Runway into Second... Read More

PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced it will host a virtual key opinion leader (KOL) event on Wednesday, November 20,... Read More

Name Change Reflects Extensive Scientific and Corporate Brand Equity Previously Established under Grace Therapeutics Grace Therapeutics will begin trading on Nasdaq under the trading symbol "GRCE" effective October 28, 2024 Virtual Key Opinion Leader Event to be held on November 20 th PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company... Read More

PRINCETON, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that patient enrollment has been completed in the Company’s Phase 3 STRIVE-ON safety trial (the... Read More

PRINCETON, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that Prashant Kohli, Chief Executive Officer of Acasti, will present live at the Life Sciences... Read More

PRINCETON, N.J., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will participate in the H.C. Wainwright 26th Annual Global Investment Conference ,... Read More

Surpassed 50% Enrollment Milestone in Pivotal Phase 3 STRIVE-ON Safety Trial of GTX-104 Company Anticipates Completion of Patient Enrollment in the STRIVE-ON Trial in Late 2024 to Early 2025, with NDA Submission on Track for 1H Calendar 2025 Projected Cash Runway into Second Calendar Quarter 2026 PRINCETON, N.J., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage,... Read More

PRINCETON, N.J., June 27, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company’s pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial– NCT05995405 ) has... Read More

Patient Enrollment in Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104 On-Track for Potential NDA Submission in 1H Calendar 2025 Projected Cash Runway into Second Calendar Quarter 2026 PRINCETON, N.J., June 21, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical... Read More

PRINCETON, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel, injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will be participating in the BIO International Convention taking place at the San... Read More

Projected Cash Runway Extends into Second Calendar Quarter 2026, Well Beyond Potential 1H 2025 Submission of GTX-104 New Drug Application (NDA) Patient Enrollment in Pivotal STRIVE-ON Phase 3 Trial Continues, On Track for NDA Submission Timeline Poster Highlighting the STRIVE-ON Trial Presented at 2024 International Stroke Conference PRINCETON, N.J., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti... Read More

PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster outlining its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial– NCT05995405 ) has... Read More

PRINCETON, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel intravenous formulation of nimodipine being developed to address the high unmet medical needs for a rare disease, aneurysmal Subarachnoid Hemorrhage (aSAH), today announced that Chief Executive Officer Prashant Kohli will participate in the following... Read More

Announced Dosing of First Patient in Pivotal STRIVE-ON Phase 3 Randomized Trial for GTX-104 Completed $7.5 Million Private Placement Equity Financing led by ADAR1 Partners, LP, Providing Funding Well Beyond Anticipated Submission of GTX-104 New Drug Application (NDA) Highlighted the Potential of GTX-104 as New Treatment Standard for Aneurysmal Subarachnoid Hemorrhage (aSAH) in Key Opinion Leader Virtual Webinar Presented... Read More

With achievement of enrollment milestone, pivotal STRIVE-ON safety trial on track for potential NDA submission anticipated to occur in the first half of calendar 2025 Recently announced $7.5 million private placement financing extends projected cash runway to the first calendar quarter of 2026 PRINCETON, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma... Read More

PRINCETON, N.J., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that it will host a virtual KOL event titled GTX-104: a potential new treatment standard for rare and... Read More

PRINCETON, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that it has closed a private placement of the Company's securities pursuant to the terms of a securities... Read More

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company’s management will be participating in the 25th Annual H.C. Wainwright Global Investment... Read More

New leadership team singularly focused on executing GTX-104 strategy Announced alignment with the U.S. Food and Drug Administration (FDA) for Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104 with first patient expected to be dosed prior to the end of 2023 Cash and cash equivalents as of quarter end were $21.6 million; company reiterates projected cash runway to Q2 2025, beyond potential submission of GTX-104 New Drug... Read More

PRINCETON, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) ("Acasti" or the "Company"), a late-stage, biopharma company advancing GTX-104 its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster presenting a pharmacokinetic comparison of GTX-104 with oral nimodipine has been accepted... Read More

STRIVE-ON is a pivotal Phase 3 trial of GTX-104 to evaluate its comparable safety and tolerability profile relative to oral nimodipine in patients hospitalized with aSAH LAVAL, QB , July 10, 2023 /PRNewswire/ -- Acasti Pharma Inc. (Nasdaq: ACST) ("Acasti" or the "Company"), a late-stage, biopharma company advancing GTX-104, today announced WuXi Clinical Development, Inc. ("WuXi Clinical"), a wholly owned subsidiary of WuXi... Read More

LAVAL, QB , July 7, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will effect a 1-for-6 reverse split of its issued and outstanding common shares. The reverse... Read More

STRIVE-ON is the pivotal Phase 3 trial of GTX-104 to evaluate its comparable safety and tolerability profile relative to oral nimodipine in patients hospitalized with aSAH GTX-104 has been administered in over 150 healthy volunteers to-date and has demonstrated comparable safety profile to oral nimodipine Company confirms its projected cash runway through a potential GTX-104 New Drug Application (NDA) submission in the first... Read More

LAVAL, Québec , June 23, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial and operational results for the fiscal year ended March 31, 2023 . Recent Highlights United States... Read More

LAVAL, QC , June 22, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced the appointment of W. Taylor Kimberly , MD, PhD, Alejandro A. Rabinstein, MD and Sherry H-Y. Chou, MD to its... Read More

LAVAL, QC , May 17, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), announced today that Prashant Kohli , CEO, will be participating in a Company Webcast and Panel Presentation at the Lytham... Read More

Company successfully submits GTX-104 Pivotal Phase 3 protocol IND amendment to the FDA with expectation for first patient dosed in calendar Q4 2023 Strategic realignment prioritizes GTX-104 and expects to extend cash runway through a potential New Drug Application (NDA) filing for GTX-104 LAVAL , Québec , May 8, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma... Read More

LAVAL, QC , April 4, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage specialty pharma company advancing drug candidates for rare and orphan diseases, today announced the appointment of Prashant Kohli as Acasti's new Chief Executive Officer, succeeding Jan D'Alvise. The parties have mutually agreed to part ways, and Ms. D'Alvise will be stepping down from the board. Prashant... Read More

Company expects the first patient to be enrolled during the second half of 2023 LAVAL, QC , April 4, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, specialty pharma company advancing drug candidates for rare and orphan diseases, today announced that it received a Type C written meeting response and clarifying feedback from the United States Food and Drug Administration (FDA)... Read More

LAVAL, QC , March 30, 2023 /PRNewswire/ -- Acasti Pharma Inc. (" Acasti " or the " Company ") (NASDAQ: ACST) a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that Mr. Jean-Marie (John) Canan had tendered his resignation from the Board of Directors of the Company, such resignation to take effect immediately. The Company's board of... Read More

Acasti also confirms no exposure to Silicon Valley Bank ("SVB") or Silvergate Bank LAVAL , Québec , March 13, 2023 /CNW/ -- 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 rare and orphan diseases, today announced that it has applied and received approval for a voluntary delisting of its common... Read More

LAVAL, QC , March 8, 2023 /CNW/ -- 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 rare and orphan diseases, today announced Jan D'alvise, CEO, will present and host one-on-one meetings with investors at the Oppenheimer 33rd Annual Healthcare Conference, held virtually and taking place on March... Read More

LAVAL, QC , Feb. 28, 2023 /CNW/ -- 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 rare and orphan diseases, recognizes and celebrates Rare Disease Day ( February 28 ), as established by the European Organization for Rare Diseases. "Rare diseases impact approximately 300 million patients around the... Read More

Company to Host Conference Call Today at 1:00pm ET LAVAL, Québec, Feb. 14, 2023 (GLOBE NEWSWIRE) -- 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 rare and orphan diseases, today announced financial and operational results for the third quarter ended December 31, 2022 Recent Highlights The Company... Read More

Call to be held on Tuesday, February 14th at 1:00 PM Eastern Time LAVAL, QB , Feb. 7, 2023 /PRNewswire/ -- 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 rare and orphan diseases, today announced that it will host a conference call at 1:00 PM Eastern Time on Tuesday , February 14, 2023, to discuss... Read More

LAVAL, Québec, Jan. 25, 2023 (GLOBE NEWSWIRE) -- 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 rare and orphan diseases, announces that it has received notification from the NASDAQ Listing Qualifications Department ("NASDAQ") that it is eligible for an additional 180 calendar days, or until July... Read More

LAVAL, Québec, Jan. 24, 2023 (GLOBE NEWSWIRE) -- 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 rare and orphan diseases, today announced Jan D’Alvise, CEO, will present and host one-on-one meetings with investors at the Lytham Partners Investor Select Conference, taking place virtually on January... Read More

LAVAL, Québec, Jan. 13, 2023 (GLOBE NEWSWIRE) -- 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 rare and orphan diseases, today announced Jan D’alvise, CEO, will present and host one-on-one meetings with investors at the Sidoti January Virtual Investor Conference, taking place on January 18-19,... Read More

LAVAL, Québec, Jan. 05, 2023 (GLOBE NEWSWIRE) -- 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 rare and orphan diseases, today announced that it will host a conference call on Tuesday, January 10, 2023 at 4:30 p.m. ET to review the recently reported preliminary topline results from two separate... Read More

LAVAL, Québec, Dec. 28, 2022 (GLOBE NEWSWIRE) -- 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 rare and orphan diseases, announces that the preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 met all outcome measures. The objectives of the study were to evaluate the... Read More

LAVAL, Québec, Dec. 22, 2022 (GLOBE NEWSWIRE) -- 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 rare and orphan diseases, today announced that preliminary topline results for its single-dose, pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the... Read More