Grace Therapeutics, INC 8-K filings

Grace Therapeutics announced its second quarter 2026 financial results, reporting a net loss of $15.8 million and providing an update on the ongoing efforts to resubmit its New Drug Application for GTx-104.

Grace Therapeutics announced receipt of FDA meeting minutes regarding GTx-104, outlining a path for NDA resubmission with a dual-source manufacturing strategy.

Grace Therapeutics, Inc. has updated its corporate presentation, detailing progress on its lead drug candidate GTx-104 for aneurysmal subarachnoid hemorrhage (aSAH) and providing an update on its other programs.

Grace Therapeutics announced its fiscal year-end financial results for 2026, reporting a reduced net loss and providing an update on its GTx-104 New Drug Application following a Complete Response Letter from the FDA.

Grace Therapeutics announces the departure of VP of Clinical Operations Carrie DAndrea, who will transition to a consulting role.

Grace Therapeutics, Inc. has updated its corporate presentation, detailing progress on its lead drug candidate GTx-104 for aneurysmal subarachnoid hemorrhage (aSAH) and providing an outlook on other pipeline programs.

Grace Therapeutics announced the FDA issued a Complete Response Letter for its New Drug Application for GTx-104, citing CMC and non-clinical issues.

Grace Therapeutics announced its third quarter 2026 financial results and provided a business update, highlighting the FDA's PDUFA target date for GTx-104.

Grace Therapeutics, Inc. has updated severance agreements for its CEO and four other executive officers, enhancing protections in certain termination scenarios.

Grace Therapeutics announced FDA acceptance of its New Drug Application for GTx-104 for aSAH, setting an April 23, 2026 PDUFA date, alongside its Q2 2026 financial results.

Grace Therapeutics, Inc. announced it secured $4.0 million from warrant exercises and the FDA set an April 23, 2026 PDUFA date for its GTx-104 NDA.

Grace Therapeutics announced a new U.S. patent for GTx-104's dosing regimen, extending protection to 2043 and strengthening its intellectual property for aSAH treatment.

Grace Therapeutics, Inc. announced that its stockholders approved all proposals at the Annual Meeting, including the election of five directors and executive compensation.

Grace Therapeutics announced the FDA's acceptance of its New Drug Application for GTx-104, a novel nimodipine formulation for aSAH, setting a PDUFA target date of April 23, 2026.

Grace Therapeutics submitted a New Drug Application for GTx-104 to the FDA for aSAH treatment, reporting a net loss of $3.4 million for the quarter ended June 30, 2025.

Grace Therapeutics, Inc. announced the submission of its New Drug Application for GTx-104 to the U.S. Food and Drug Administration, a significant step towards addressing unmet medical needs in aneurysmal subarachnoid hemorrhage patients.

Grace Therapeutics, Inc. announced a significant reduction in its fiscal year 2025 net loss, positive Phase 3 trial results for its lead drug GTx-104, and secured $15 million in upfront financing, with an NDA submission for GTx-104 expected by the end of June 2025.

Grace Therapeutics has announced alignment with the FDA regarding its planned New Drug Application (NDA) submission for GTx-104, a novel injectable formulation of nimodipine for aneurysmal subarachnoid hemorrhage (aSAH) patients, with the NDA submission anticipated in Q2 2025.

Grace Therapeutics provides an update on its corporate presentation, emphasizing the potential of GTx-104 for aneurysmal subarachnoid hemorrhage (aSAH) and its recent Phase 3 trial results.

Grace Therapeutics reports successful Phase 3 trial for GTx-104 and secures up to $30 million in financing to support its commercialization efforts.

Grace Therapeutics announces a private placement aiming to raise up to $30 million to support the development of GTx-104.

Grace Therapeutics reported its fiscal second quarter 2025 financial results, highlighted by the completion of patient enrollment in the Phase 3 STRIVE-ON trial and a projected cash runway into the second quarter of 2026.

Grace Therapeutics, Inc. has officially changed its name from Acasti Pharma Inc. and updated its ticker symbol on the Nasdaq Stock Market.

Acasti Pharma Inc. is changing its name to Grace Therapeutics, effective October 28, 2024, and will trade under the ticker symbol GRCE, reflecting a renewed focus on its lead drug candidate, GTx-104.

Acasti Pharma Inc. has successfully changed its jurisdiction of incorporation from Quebec, Canada, to Delaware, USA, following shareholder approval.

Acasti Pharma Inc. shareholders approved the 2024 Equity Incentive Plan and a series of corporate restructuring proposals at their annual meeting on September 30, 2024.

Acasti Pharma has completed patient enrollment in its Phase 3 STRIVE-ON safety trial for GTX-104, an injectable treatment for aneurysmal subarachnoid hemorrhage, with data readout expected in early 2025.

Acasti Pharma has formalized an employment agreement with CEO Prashant Kohli, outlining his compensation, bonus potential, and other terms of employment.

Acasti Pharma announced it has surpassed the 50% enrollment milestone in its Phase 3 STRIVE-ON safety trial for GTX-104 and anticipates an NDA submission in the first half of 2025.

Acasti Pharma announced that its pivotal Phase 3 STRIVE-ON safety trial for GTX-104 has exceeded the 50% enrollment milestone, with completion of patient enrollment anticipated in late 2024 to early 2025.