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Grace Therapeutics, Inc. develops specialty biopharmaceutical products led by GTx-104, a clinical-stage injectable formulation of nimodipine for intravenous infusion in patients with aneurysmal subarachnoid hemorrhage, or aSAH. The company’s updates center on the GTx-104 New Drug Application, FDA correspondence, chemistry, manufacturing and controls matters, and clinical data from the STRIVE-ON Phase 3 safety trial.
Recurring news also covers medical-conference presentations, intellectual-property developments for nimodipine parenteral administration, quarterly financial results, corporate presentations, and capital actions such as warrant exercises tied to prior private placements.
Grace Therapeutics (NASDAQ: GRCE) has secured a private placement financing of up to $30 million, led by Nantahala Capital and ADAR1 Partners, LP. The deal includes $15 million in upfront gross proceeds and potential additional $15 million through warrant exercises.
The company will issue 4,418,292 shares of common stock (or pre-funded warrants) and accompanying warrants at a combined price of $3.395 per share. The warrants will be exercisable immediately at the same price and will expire on the earlier of 60 days after FDA approval of GTx-104 or September 25, 2028.
The funds will support general corporate purposes and pre-commercial development of GTx-104, a novel injectable nimodipine formulation for aneurysmal Subarachnoid Hemorrhage (aSAH) patients. The private placement is expected to close on February 11, 2025.
Grace Therapeutics (NASDAQ: GRCE) announced positive results from its Phase 3 STRIVE-ON safety trial for GTx-104, an injectable formulation of nimodipine for aneurysmal Subarachnoid Hemorrhage (aSAH) patients. The trial, involving 102 patients, met its primary endpoint with a 19% reduction in clinically significant hypotension compared to oral nimodipine (28% vs 35%).
Key findings include: 54% of GTx-104 patients achieved ≥95% relative dose intensity versus 8% for oral nimodipine; a 29% relative increase in favorable outcomes at 90 days; improved quality of life measures; and fewer ICU readmissions and ventilator days. While safety profiles were comparable, there were eight deaths in the GTx-104 arm versus four in the oral nimodipine arm, all attributed to disease severity.
The company plans to submit a New Drug Application (NDA) in the first half of 2025.
Grace Therapeutics (Nasdaq: GRCE), a late-stage biopharma company, has announced its participation in key investor events for January 2025. The company, which is developing GTx-104, a novel injectable formulation of nimodipine for aneurysmal subarachnoid hemorrhage (aSAH) patients, will be represented by CEO Prashant Kohli at two major events:
- 14th Annual LifeSci Partners Corporate Access Event on January 13, 2025
- BIO One-on-One Partnering™ on January 14, 2025
The company recently hosted a virtual KOL event on November 20, 2024, featuring experts Dr. Abhishek Ray from University Hospitals and Dr. Andrew Webb from Massachusetts General Hospital, who discussed the unmet medical needs and treatment landscape for aSAH patients.
Grace Therapeutics (NASDAQ: GRCE) announced its participation in the American Society of Health-System Pharmacists (ASHP) mid-year clinical meeting from December 8-12, 2024, in New Orleans. The company will focus on educating health-system pharmacists about unmet needs in aneurysmal subarachnoid hemorrhage (aSAH) treatment and their product GTx-104, a novel injectable nimodipine formulation.
The company expects data readout from their Phase 3 STRIVE-ON trial in Q1 2025. The ASHP represents 60,000 pharmacists and healthcare professionals across various patient care settings. Additionally, Grace recently hosted a virtual KOL event on November 20, 2024, featuring experts discussing aSAH treatment needs.
Grace Therapeutics (NASDAQ: GRCE) reported Q2 fiscal 2025 financial results, highlighting completion of patient enrollment in Phase 3 STRIVE-ON safety trial for GTx-104, their injectable nimodipine formulation for aSAH treatment. The company posted a net loss of $3.4 million ($0.30 per share) compared to $3.3 million last year. R&D expenses increased to $3.0 million from $0.5 million, while G&A expenses rose to $1.9 million. With $15.1 million in cash, the company expects runway into Q2 2026. Grace anticipates STRIVE-ON trial data readout in Q1 2025 and NDA submission in 1H 2025.
Grace Therapeutics (Nasdaq: GRCE) announced a virtual Key Opinion Leader (KOL) event scheduled for November 20, 2024, at 2:00 PM ET. The event will focus on GTx-104, their novel injectable formulation of nimodipine developed for aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening condition.
Featured speakers include Dr. Abhishek Ray from University Hospitals and Dr. Andrew Webb from Massachusetts General Hospital. They will discuss the unmet medical needs and current treatment landscape for aSAH patients. The presentation will be followed by a Q&A session.