aibioGrace Therapeutics NDA acceptance opens window on up to $7.6 million in warrants
Tickers GRCE
The FDA accepted the GTx-104 application on August 22, 2025, with an April 23, 2026 target date. Warrants from the September 2023 private placement, at $3.003 each, expire on the earlier of the 60th day after acceptance or September 25, 2028.
Key facts
- Company
- Grace Therapeutics, Inc. (NASDAQ: GRCE)
- News type
- Financings
- Primary source
- Grace Therapeutics, Inc. 8-K (2025-08-27)
The warrants and the filing
Grace Therapeutics, Inc. (Nasdaq: GRCE) said in an 8-K filed August 27, 2025 that the U.S. Food and Drug Administration accepted its New Drug Application for GTx-104 for formal review on August 22, 2025. GTx-104 is an injectable form of nimodipine for aneurysmal subarachnoid hemorrhage, or aSAH, a type of stroke caused by bleeding over the surface of the brain. The FDA set a PDUFA target date of April 23, 2026.
Acceptance triggers the potential exercise of up to $7.6 million in warrants issued in a private placement the company completed in September 2023. Each warrant is exercisable for one share of common stock at $3.003. The warrants are exercisable now, and they expire on the earlier of the 60th day after the FDA accepts an NDA for GTx-104 or September 25, 2028. The release does not give the number of shares underlying the warrants.
The release does not name a placement agent or other financial advisor for the 2023 private placement. The money from exercises depends on holders choosing to pay $3.003 a share inside a window that closes early, so the company cannot count on the full $7.6 million.
The trial behind the application
The application relies on the Phase 3 STRIVE-ON safety trial. It was a prospective, randomized, open-label trial of GTx-104 against oral nimodipine in patients hospitalized with aSAH. Fifty patients received GTx-104 and 52 received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug. The release says the trial met that endpoint, with patients on GTx-104 showing a 19% reduction, or 28% against 35%.
The release also reports eight deaths in the GTx-104 arm against four in the oral nimodipine arm, and says the survival status of one patient on the oral arm was unknown. It says all deaths were due to the underlying disease and none was related to either drug. The release describes adverse events as comparable between the arms, and it cites a 29% larger share of patients with favorable functional outcomes at 90 days on GTx-104. Those comparisons are the company's own reading of an open-label trial.
The company and the critical read
The 10-K filed June 23, 2025 describes a company focused on rare and orphan diseases, with three clinical-stage candidates and more than 40 granted and pending patents. It says the candidates are reformulations of approved compounds, pursued under Section 505(b)(2), and that all three have orphan drug designation. For GTx-104, the 10-K estimates savings of approximately $4.3 million from tax credits and a waiver of NDA fees.
The release calls STRIVE-ON a safety trial, and it says the data provide support for improved clinical outcomes in aSAH patients. Those outcome claims go beyond the trial's stated primary endpoint, which was hypotension. The efficacy case for the aSAH indication is still ahead of the FDA review, with the April 23, 2026 target date in view.
The release says orphan designation generally provides seven years of marketing exclusivity after approval, and that the company believes its patents will protect market value beyond that. Neither claim is a result the FDA has reviewed. The warrant window is the nearest financing event in the release, and it is a conditional one.