Grace Therapeutics announces submission to U.S. FDA of NDA for GTx-104

Grace Therapeutics (GRCE) announced the submission to the U.S. Food and Drug Administration, FDA, of the Company’s New Drug Application, NDA, for GTx-104. The application includes a comprehensive data package, including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when compared to orally administered nimodipine. Submission of the NDA has the potential to trigger the exercise of up to $7.6 million in warrants issued as part of a private placement the Company completed in September 2023. Under the terms of the September 2023 private placement, each warrant is exercisable for one share of common stock at an exercise price of $3.003 per share. These warrants will be immediately exercisable and will expire on the earlier of the 60th day after the date of the acceptance by the FDA of a NDA for the Company’s product candidate GTX-104 or September 25, 2028.