Business UpdateJun 18, 2026, 07:36 AM
Grace Therapeutics Files 2026 10-K; GTx-104 Faces FDA CRL
AI Summary
Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.) has filed its Annual Report on Form 10-K for the fiscal year ended March 31, 2026. The company is focusing on developing treatments for rare and orphan diseases, with its lead candidate GTx-104 for aneurysmal subarachnoid hemorrhage (aSAH) being a key priority. While the Phase 3 STRIVE-ON trial for GTx-104 met its primary endpoint, the company received a Complete Response Letter from the FDA in April 2026 due to manufacturing and non-clinical issues, not safety or efficacy concerns. Grace Therapeutics is deferring development of other candidates, GTx-102 and GTx-101, to concentrate resources on GTx-104 and is seeking additional financing.
Key Highlights
- Grace Therapeutics (formerly Acasti Pharma) filed its 2026 Form 10-K.
- The company is focused on developing and commercializing products for rare and orphan diseases using novel drug delivery technologies.
- GTx-104, an injectable formulation of nimodipine for aSAH, is the lead drug candidate.
- GTx-104's Phase 3 STRIVE-ON trial met its primary endpoint, showing a 19% reduction in hypotension compared to oral nimodipine.
- Grace Therapeutics received a Complete Response Letter (CRL) from the FDA for GTx-104 in April 2026, citing CMC and non-clinical issues, not safety or efficacy.
- The company is prioritizing GTx-104 development and has decided to defer internal development funding for GTx-102 and GTx-101.
- GTx-104 has an estimated market opportunity of 42,500 patients annually in the US, with potential global markets in the EU and China.
- The company is seeking additional financing to support operations and development.
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