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) 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.