Grace Therapeutics posts corporate presentation on GTx-104 IV nimodipine program for aneurysmal subarachnoid hemorrhage

Reuters2026/07/28 11:23

By:Reuters

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Grace Therapeutics outlined a targeted FDA NDA resubmission plan for IV nimodipine candidate GTx-104 in aneurysmal subarachnoid hemorrhage.
Complete response letter centered on CMC and manufacturing; no clinical safety or efficacy deficiencies cited, no additional clinical data requested.
Strategy includes remediation at the current CDMO requiring FDA reinspection, parallel US second-source transfer, and completion of non-clinical studies.
Phase 3 STRIVE-ON safety trial met its primary endpoint; clinically significant hypotension occurred in 28% on GTx-104 vs 35% on oral capsules.
Company highlighted higher dose intensity at 95% or more in 54% of GTx-104 patients vs 8% on oral capsules, with a 29% relative increase in good recovery at 90 days.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Grace Therapeutics Inc. published the original content used to generate this news brief on July 28, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Grace Therapeutics posts corporate presentation on GTx-104 IV nimodipine program for aneurysmal subarachnoid hemorrhage

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