GRCE Grace Therapeutics

Grace Therapeutics receives Type A meeting minutes on GTx-104 CRL

The FDA minutes confirm the April 23, 2026 CRL cited only manufacturing cGMP issues at the contract manufacturer and requested additional leachables data and excipient toxicology assessments; no clinical safety or efficacy deficiencies were identified. Grace is advancing a dual-source manufacturing strategy, including technology transfer to a U.S.-based second site, to support NDA resubmission.

Grace Therapeutics receives CRL for GTx-104 NDA

FDA issued a Complete Response Letter for the GTx-104 NDA citing outstanding CMC and non-clinical items. No additional clinical data were requested. The company plans to request a Type A meeting and resubmit the application after addressing the cited deficiencies.

Grace Therapeutics: STRIVE-ON Phase 3 results accepted for AAN 2026 poster

An abstract of the completed STRIVE-ON Phase 3 safety trial for GTx-104 (nimodipine IV) has been accepted for a poster presentation at the 2026 American Academy of Neurology meeting on April 21, 2026. The trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension versus oral nimodipine, plus better dose intensity and functional outcomes.

Grace Therapeutics: FDA sets April 23, 2026 PDUFA date for GTx-104 NDA

The FDA has established April 23, 2026 as the PDUFA target date for the review of Grace Therapeutics' NDA seeking approval of GTx-104 (nimodipine IV infusion) for aneurysmal subarachnoid hemorrhage. The company is continuing pre-commercial planning in anticipation of a potential approval decision on or before that date.

Grace Therapeutics NDA for GTx-104 accepted; PDUFA set April 23, 2026

FDA accepted the NDA for GTx-104 (nimodipine IV) for formal review on August 22, 2025. The agency set a PDUFA target action date of April 23, 2026 for the aSAH indication. The submission is supported by the completed Phase 3 STRIVE-ON safety trial.

Grace Therapeutics NDA for GTx-104 accepted; PDUFA set April 23, 2026

The FDA has formally accepted Grace Therapeutics’ New Drug Application for GTx-104 (nimodipine) for review. A PDUFA target action date of April 23, 2026 has been assigned. The acceptance also triggered the expiration of the remaining 2023 private-placement warrants.

Grace Therapeutics granted sixth U.S. patent for GTx-104 I.V. dosing regimen

The USPTO issued U.S. Patent No. 12,414,943 covering the I.V. dosing regimen used in the Phase 3 STRIVE-ON trial. This method-of-use patent extends IP protection for GTx-104 to 2043, adding to the five existing formulation patents that expire in 2037. The new patent strengthens the exclusivity position ahead of the planned NDA submission for GTx-104 in aSAH.