Grace Therapeutics Prepares NDA for GTx-104 IV Nimodipine After Encouraging FDA Feedback

Grace Therapeutics, Inc. (Nasdaq: GRCE), a late-stage biopharma company, shared new details about its recent Type C meeting with the U.S. Food and Drug Administration (FDA). The discussion focused on the company’s lead candidate, GTx-104—a novel injectable formulation of nimodipine developed for IV infusion in patients with aneurysmal subarachnoid hemorrhage (aSAH). The purpose of the meeting was to gain FDA feedback on the completed Phase 3 STRIVE-ON safety trial and on the company’s planned New Drug Application (NDA), including clinical, non-clinical, and manufacturing components.

According to Grace, the FDA provided feedback indicating that the current data and regulatory documentation appear sufficient to support an NDA submission.

“Our engagement with the FDA has been both encouraging and constructive,” said Prashant Kohli, CEO of Grace Therapeutics. “aSAH is a serious condition with limited treatment innovation over the past 40 years. The current enteral administration of nimodipine poses challenges due to the drug’s pharmacokinetics and the complex pathophysiology of aSAH. GTx-104 addresses these limitations through IV infusion, offering potential improvements in dose compliance, reduced incidence of hypotension, and better functional recovery—as demonstrated in our STRIVE-ON trial. We believe GTx-104 can truly make a difference in patient outcomes.”

The company plans to submit its NDA in Q2 2025. The FDA will evaluate the full application before making a decision on acceptance.