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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) reported first quarter 2027 results for the three months ended June 30, 2026, and provided a business update on lead asset GTx-104 for aneurysmal subarachnoid hemorrhage. The company continues preparing a resubmission of its GTx-104 NDA after an FDA Complete Response Letter that cited only chemistry, manufacturing and controls (CMC) and non-clinical items, with no clinical safety or efficacy deficiencies.
Grace adopted a dual-source manufacturing strategy, advancing remediation at its current contract manufacturer while transferring technology to a second U.S.-based manufacturer, with resubmission timing depending on which becomes ready first. The company closed a $10 million private placement to fund regulatory and manufacturing work. For the quarter, net loss was $15.8 million, or $0.91 per share, versus $3.4 million, or $0.21 per share, a year earlier, primarily reflecting a $13.5 million impairment of in-process R&D for GTx-101 and GTx-102. R&D expenses declined to $0.7 million and G&A to $1.7 million. As of August 11, 2026, cash and equivalents were $22.2 million, which Grace believes can fund planned operations through the end of calendar 2028.
Grace Therapeutics (Nasdaq: GRCE) entered a securities purchase agreement for a private placement of approximately $10 million in gross proceeds, issuing 4,761,904 common shares at $2.10 per share, priced at-the-market under Nasdaq rules. Closing is expected on August 6, 2026, subject to customary conditions.
According to the company, net proceeds, together with existing cash, are expected to extend its cash runway to the end of calendar 2028, primarily funding manufacturing and regulatory work for lead asset GTx-104. Grace is executing a dual-source manufacturing strategy, transferring technology to a second U.S.-based contract manufacturer while its current manufacturer addresses FDA compliance issues. NDA resubmission timing for GTx-104 will depend on which manufacturing pathway becomes ready first, with the company also working on remaining CMC and non-clinical items from the FDA Complete Response Letter.
Grace Therapeutics (Nasdaq: GRCE) received formal Type A meeting minutes from the U.S. FDA regarding the Complete Response Letter (CRL) issued on April 23, 2026 for GTx-104, its IV nimodipine candidate for aneurysmal subarachnoid hemorrhage (aSAH).
The FDA did not identify any clinical safety or efficacy deficiencies for GTx-104 and did not request additional clinical data. Outstanding CRL items focus on cGMP compliance at the current contract manufacturing organization, plus additional leachables data time points and excipient toxicology risk assessments, which the company plans to address with required non-clinical studies.
Grace Therapeutics is advancing a dual-source manufacturing strategy, maintaining its existing manufacturer while transferring technology to a second U.S.-based site to support NDA resubmission. GTx-104’s STRIVE-ON trial met its primary endpoint, showing lower clinically significant hypotension versus oral nimodipine, and has Orphan Drug Designation with potential U.S. market exclusivity.
Grace Therapeutics (Nasdaq: GRCE) reported fiscal 2026 results and regulatory updates for GTx-104 for aSAH.
The FDA issued an April 2026 Complete Response Letter citing CMC, non-clinical and cGMP items, with no clinical deficiencies. A Type A meeting is scheduled. Net loss was $7.8M versus $9.6M in 2025; R&D fell to $2.4M and G&A rose to $8.7M. Cash was $17.0M, and the company believes this funds operations for at least 12 months. Phase 3 STRIVE-ON data were presented at multiple conferences, and new U.S. patent protection extends potential GTx-104 coverage to 2043 alongside Orphan Drug Designation.
Grace Therapeutics (Nasdaq: GRCE) announced the FDA issued a Complete Response Letter (CRL) on April 23, 2026 for the NDA for GTx-104, citing items in Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections.
The FDA did not request additional clinical data. Cited issues include leachables data for packaging, non-clinical toxicology risk assessments, and manufacturing deficiencies at the contract manufacturer. The company intends to request a Type A meeting and resubmit after addressing the items.
Grace Therapeutics (Nasdaq: GRCE) announced that an abstract reporting results from its STRIVE-ON Phase 3 safety trial of GTX-104 (nimodipine IV) was accepted for presentation at the American Academy of Neurology annual meeting, April 18-22, 2026.
The STRIVE-ON results will appear as a poster on April 21, 2026 at 1:00 pm CT in Session S21: Neurocritical Care, titled "Safety and Tolerability of GTX-104 Compared with Oral Nimodipine".
Grace Therapeutics (Nasdaq: GRCE) announced that abstracts on the unmet needs and potential benefits of GTx-104 in aneurysmal subarachnoid hemorrhage (aSAH) were accepted for two March 2026 medical conferences.
The company will discuss Phase 3 STRIVE-ON trial data and present a poster on safety and tolerability versus oral nimodipine.
Grace Therapeutics (Nasdaq: GRCE) announced CEO Prashant Kohli will present at TD Cowen’s 46th Annual Health Care Conference in Boston on March 4, 2026 at 10:30 AM ET. An archived replay will be available for 90 days, and the CEO will also take part in investor meetings.
According to the company, Grace is advancing GTx-104, a clinical-stage injectable nimodipine formulation for IV infusion targeting aneurysmal subarachnoid hemorrhage patients.
Grace Therapeutics (Nasdaq: GRCE) reported Q3 FY2026 results and business updates focused on its NDA for GTx-104 in aneurysmal subarachnoid hemorrhage (aSAH). The FDA set a PDUFA target date of April 23, 2026. Q3 net loss was $2.3M versus $4.2M year-ago; cash was $18.7M at Dec 31, 2025, and potential warrant proceeds total $15.0M. The company completed the STRIVE-ON Phase 3 safety trial and presented results at a 2025 scientific meeting while continuing pre-commercial planning.
Grace Therapeutics (Nasdaq: GRCE) announced that CEO Prashant Kohli will present at the Craig-Hallum 16th Annual Alpha Select Conference on November 18, 2025 in New York.
Grace is a late-stage biopharma advancing GTx-104, an injectable nimodipine formulation for IV infusion to treat aneurysmal subarachnoid hemorrhage (aSAH) patients. The Alpha Select Conference is invitation-only; attending companies are selected for being smaller, underfollowed public companies with potential to scale. Investors seeking a meeting should contact their Craig-Hallum representative.