Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104

Written by Emily J. Thompson, Senior Investment Analyst

Source: Newsfilter

Updated: Jun 25 2025

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Source: Newsfilter

NDA Submission for GTx-104: Grace Therapeutics has submitted a New Drug Application (NDA) to the FDA for GTx-104, an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH), supported by positive results from the Phase 3 STRIVE-ON safety trial.
Financial Implications and Market Potential: The NDA submission could trigger up to $7.6 million in financing warrants, and GTx-104's Orphan Drug Designation may provide seven years of marketing exclusivity, addressing significant unmet medical needs in aSAH treatment.

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Grace Therapeutics, Inc. is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Its novel drug delivery technologies have the potential to improve the performance of marketed drugs by achieving faster onset of action, and reduced side effects. Its lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. The nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. Its other pipeline includes GTX-102, which is targeted as the first potential therapy for the treatment of ataxia-telangiectasia (AT) in a pediatric population and GTx-101, which is a topical administration via a bioadhesive, film-forming polymer, for the treatment of pain associated with postherpetic neuralgia.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

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