Business
Grace 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, 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 Private Placement Financing of $15 Million in Upfront Gross Proceeds with t
About this update from Grace Therapeutics, Inc.
[{"type":"image","alt":"Grace Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Grace Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":238,"height":52,"url":"https://media.zenfs.com/en/globenewswire.com/d9c2bb0e1d56296ef30bd84c47a14138"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Sz8Ci7mRHoF.VDufghVM3w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTkyO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/d9c2bb0e1d56296ef30bd84c47a14138","width":238,"height":52}},"lazy":false},{"type":"text","content":"Held Type C meeting with FDA on Planned New Drug Application (NDA) Submission, Including Clinical, Non-clinical, and Chemistry, Manufacturing, and Control (CMC) Requirements","length":173,"tagName":"p"},{"type":"text","content":"NDA On Track for Submission to FDA in First Half of Calendar 2025","length":65,"tagName":"p"},{"type":"text","content":"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","length":176,"tagName":"p"},{"type":"text","content":"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 Approximately $30 Million in Potential Total Gross Proceeds","length":263,"tagName":"p"},{"type":"text","content":"PRINCETON, N.J., June 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 IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced the financial results and business highlights for the fiscal year ended March 31, 2025.","length":474,"tagName":"p"},{"type":"text","content":"“During our 2025 fiscal year we made significant progress in both clinical and corporate goals, led by our announcement of positive topline data from our Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) and alignment with the U.S. Food and Drug Administration (FDA) on our planned submission of an NDA for GTx-104 for the treatment of aSAH,” said Prashant Kohli, CEO of Grace Therapeuti...