GRCE

8-K - Grace Therapeutics, Inc. (0001444192) (Filer)

FDA Issued Complete Response Letter Citing Outstanding Items Related to Chemistry, Manufacturing, and Controls and Non-Clinical Information  FDA Does not Request Additional Clinical Data Company Intends to Resubmit Application Following Resolution of Cited Items PRINCETON, N.J., April 23, 2026 (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 intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that the U.S. Food and Drug Administ

PRINCETON, N.J., April 14, 2026 (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 intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that an abstract highlighting the results from the Company's STRIVE-ON Phase 3 Safety Trial has been accepted for presentation at the upcoming 2026 American Academy of Neurology annual meeting, to be held April 18-22, 2026 in Chicago, IL. The STRIVE-ON Trial results will be presented as a poster on A

PRINCETON, N.J., March 19, 2026 (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 intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that abstracts discussing the unmet medical needs and the potential benefits of GTx-104 have been accepted for presentation at two major medical conferences taking place in March 2026. The Company is participating in an industry education workshop during the Society of Critical Care Medicine's Critic

PRINCETON, N.J., Feb. 25, 2026 (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 Kohli will participate and present in TD Cowen's 46th Annual Health Care Conference, to be held March 2-4, 2026 in Boston, MA. Mr. Kohli's presentation is schedule for March 4, 2026 at 10:30 AM Eastern Time. To register for the webcast, click here. An archived replay will

8-K - Grace Therapeutics, Inc. (0001444192) (Filer)

FDA Established 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) Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Society of Vascular and Interventional Neurology Annual Meeting Company Continues Pre-Commercial Planning in Anticipation of Potential FDA Approval of NDA Submission for GTx-104 for the Treatment of Patients with aSAH PRINCETON, N.J., Feb. 12, 2026 (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 b

10-Q - Grace Therapeutics, Inc. (0001444192) (Filer)

SCHEDULE 13G/A - Grace Therapeutics, Inc. (0001444192) (Subject)

8-K - Grace Therapeutics, Inc. (0001444192) (Filer)

4 - Grace Therapeutics, Inc. (0001444192) (Issuer)

4 - Grace Therapeutics, Inc. (0001444192) (Issuer)

4 - Grace Therapeutics, Inc. (0001444192) (Issuer)

4 - Grace Therapeutics, Inc. (0001444192) (Issuer)

10-Q/A - Grace Therapeutics, Inc. (0001444192) (Filer)

PRINCETON, N.J., Nov. 17, 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 Kohli will participate/present in the upcoming Craig-Hallum 16th Annual Alpha Select Conference, to be held Tuesday, November 18, 2025 in New York, NY. Companies attending the Alpha Select Conference have been individually selected by the Craig-Hallum research team and are

8-K - Grace Therapeutics, Inc. (0001444192) (Filer)

Announced U.S. Food and Drug Administration (FDA) Acceptance for Reviewof New Drug Application (NDA) for GTx-104 FDA Established 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) Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Neurocritical Care Annual Meeting Granted Sixth U.S. Patent Covering IV Dosing Regimen for GTx-104 PRINCETON, N.J., Nov. 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

10-Q - Grace Therapeutics, Inc. (0001444192) (Filer)

PRINCETON, N.J., Nov. 11, 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 an abstract of the Company's Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (the STRIVE-ON trial–NCT05995405) has been accepted for presentation as a late breaking trial at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, to be held November 19-22, 2025 in Orlando, FL.

8-K - Grace Therapeutics, Inc. (0001444192) (Filer)

PRINCETON, N.J., Oct. 23, 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 I.V. infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced it has secured approximately $4.0 million in additional funding through exercises of common warrants that were previously issued in a private placement that the Company closed in September 2023. The Company issued 1,345,464 new shares of common stock at an exercise price of $3.003 per share. The remaining 1,1

PRINCETON, N.J., Sept. 22, 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 I.V. infusion to address significant unmet medical needs in aSAH patients, today announced that results from its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (the STRIVE-ON trial–NCT05995405) were presented at the 2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada September 18-21, 2025. In an oral presentation titled Safety and Tolerability of GTx-104 (Nimodipine Injection for I.V. Infusion

8-K - Grace Therapeutics, Inc. (0001444192) (Filer)

Grant of First Method of Use Patent Adds New Pillar to Grace's Multi-layered Intellectual Property and Potential Market Exclusivity Protection Patent Coverage Extended to 2043 PRINCETON, N.J., Sept. 18, 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 I.V. infusion to address significant unmet medical needs in aSAH patients, today announced that the U.S. Patent and Trademark Office has issued a U.S. Patent No. 12,414,943, titled "Nimodipine Parenteral Administration". The new method of use patent, publ