Welcome to our dedicated page for Grace Therapeutics news (Ticker: GRCE), a resource for investors and traders seeking the latest updates and insights on Grace Therapeutics stock.
Grace Therapeutics, Inc. (Nasdaq: GRCE) is a late-stage biopharma company developing drug candidates for rare and orphan diseases, with a primary focus on GTx-104, a clinical-stage, novel, injectable formulation of nimodipine for intravenous infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients. This news page aggregates company press releases and market-moving updates related to GRCE.
Readers can find coverage of regulatory milestones, including Grace Therapeutics’ submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for GTx-104 and the FDA’s subsequent acceptance of that NDA for formal review with a Prescription Drug User Fee Act (PDUFA) target date. News items also describe the company’s Phase 3 STRIVE-ON safety trial results comparing GTx-104 with oral nimodipine in aSAH patients, highlighting that the trial met its primary endpoint and provided evidence of clinical benefit.
The GRCE news feed further includes updates on intellectual property developments, such as the issuance of a U.S. method-of-use patent titled “Nimodipine Parenteral Administration” that covers the IV dosing regimen for GTx-104 and extends patent protection into the 2040s. Financing and corporate updates, including additional funding obtained through the exercise of common stock warrants tied to regulatory milestones, are also reported in recent releases.
Investors and observers can review announcements about scientific and medical conference presentations, where Grace Therapeutics’ pivotal STRIVE-ON data have been featured at meetings such as the Neurocritical Care Society and the Society of Vascular and Interventional Neurology. The company also issues notices of participation in investor conferences, reflecting its outreach to the institutional investment community.
By following this GRCE news page, users can monitor how Grace Therapeutics communicates progress on GTx-104, updates on its broader asset portfolio (including GTx-102 and GTx-101), and key corporate and governance disclosures that appear in both press releases and related SEC filings.
Grace Therapeutics (NASDAQ:GRCE) has submitted a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal Subarachnoid Hemorrhage (aSAH). The NDA is supported by successful Phase 3 STRIVE-ON safety trial results, which met its primary endpoint and demonstrated clinical benefits compared to oral nimodipine.
For Q1 2026, Grace reported a net loss of $3.4 million ($0.21 per share), compared to $2.6 million loss in Q1 2025. The company's cash position stands at $20.0 million, with potential additional proceeds of $22.6 million from warrant exercises. The company has secured Orphan Drug Designation for GTx-104, providing 7 years of marketing exclusivity upon FDA approval.
Grace Therapeutics (NASDAQ:GRCE) has submitted a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal Subarachnoid Hemorrhage (aSAH). The submission includes positive results from the Phase 3 STRIVE-ON safety trial, where GTx-104 met its primary endpoint and demonstrated clinical benefits compared to oral nimodipine.
The NDA submission could trigger up to $7.6 million in warrant exercises from the company's 2023 financing at $3.003 per share. Grace has secured Orphan Drug Designation for GTx-104, potentially providing 7 years of marketing exclusivity upon FDA approval. The FDA has a 60-day period to determine if the NDA is complete and acceptable for filing.
Grace Therapeutics (NASDAQ: GRCE) has announced positive alignment with the FDA regarding their planned New Drug Application (NDA) submission for GTx-104, a novel injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH) patients.
Following a Type C meeting with the FDA, the company confirmed that their current data and regulatory packages should be sufficient for NDA submission, anticipated in Q2 2025. The STRIVE-ON safety trial demonstrated that GTx-104, administered via IV infusion, showed:
- Fewer patients with clinically significant hypotension
- Higher dose compliance
- Better functional recovery
- Lower pharmacoeconomic burden
This development represents the first potential innovation in aSAH treatment in almost four decades, addressing significant unmet medical needs caused by limitations of enteral administration.
Grace Therapeutics (Nasdaq: GRCE) has announced that CEO Prashant Kohli will participate in the TD Cowen 45th Annual Health Care Conference in Boston, MA, from March 3-5, 2025. Kohli will deliver a presentation on March 4, 2025, at 2:30pm ET, which will be available via webcast, and will also conduct one-on-one investor meetings.
The company, formerly known as Acasti Pharma, is advancing GTx-104, a novel injectable formulation of nimodipine being developed for IV infusion to address unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients.
Additionally, Grace Therapeutics hosted a virtual key opinion leader (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 high unmet medical need and current treatment landscape for aSAH, a rare and life-threatening medical emergency. A replay of this event is available on the company's website.
Grace Therapeutics (NASDAQ: GRCE) reported its Q3 FY2025 financial results and business updates. The company announced that its Phase 3 STRIVE-ON safety trial for GTx-104, an injectable nimodipine formulation for aSAH patients, met its primary endpoint and showed improved clinical outcomes compared to oral administration.
The company secured a private placement financing of $15 million in upfront gross proceeds, with potential for additional $15 million through warrant exercises. The net proceeds from initial funding were $13.8 million. For Q3 FY2025, Grace reported a net loss of $4.2 million ($0.36 per share), compared to $2.4 million loss in Q3 FY2024. R&D expenses increased to $2.2 million from $1.4 million year-over-year. As of December 31, 2024, cash position stood at $11.1 million.
The company plans to submit its New Drug Application (NDA) for GTx-104 by June 2025.
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.