Grace Therapeutics, Inc.

Grace Therapeutics, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on September 17, 2026, at 8:30 a.m. Eastern Time. Shareholders of record as of July 20, 2026, will vote on the election of five director nominees, an advisory resolution on executive compensation, the ratification of KPMG LLP as the independent auditor, and the frequency of future advisory votes on executive compensation. The Board recommends voting for all proposals and for an annual frequency for executive compensation votes.

Grace Therapeutics, Inc. announced receipt of U.S. Food and Drug Administration (FDA) meeting minutes for its GTx-104 new drug application, following a Complete Response Letter (CRL). The FDA did not identify any clinical safety or efficacy deficiencies, nor did it request additional clinical data. The CRL issues are related to the current good manufacturing practice (cGMP) compliance status of the company's contract manufacturing organization and additional data requirements. Grace Therapeutics is pursuing a dual-source manufacturing strategy and completing non-clinical studies to address these items for NDA resubmission.

Grace Therapeutics received meeting minutes from the FDA regarding the Complete Response Letter (CRL) for its drug candidate, GTx-104. The FDA did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data. The CRL issues primarily concern the current good manufacturing practice (cGMP) compliance status of the company's contract manufacturing organization, along with requests for additional leachables data and excipient toxicology risk assessments. Grace Therapeutics is advancing a dual-source manufacturing strategy, including adding a U.S.-based site, to address these items for NDA resubmission.

Grace Therapeutics, Inc. announced it received a Complete Response Letter (CRL) from the FDA in April 2026 for its New Drug Application (NDA) for GTx-104, an intravenous nimodipine for aneurysmal subarachnoid hemorrhage (aSAH). The CRL cited chemistry, manufacturing, and controls (CMC) and non-clinical information, with no clinical deficiencies identified. The company plans to resubmit the NDA after resolving these items and has scheduled a Type A meeting with the FDA. The updated corporate presentation also highlighted positive Phase 3 STRIVE-ON trial data for GTx-104, showing a 19% reduction in hypotension and a 29% relative increase in good recovery at 90 days compared to oral capsules. As of March 31, 2026, the company reported $17.0 million in cash and cash equivalents.

Grace Therapeutics announced its financial results for the fiscal year ended March 31, 2026, reporting a net loss of $7.8 million, a decrease from $9.6 million in the prior year. The company also provided a business update, including the receipt of a Complete Response Letter (CRL) from the FDA in April 2026 for its GTx-104 NDA, citing Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical issues. A Type A meeting with the FDA is scheduled to clarify the resubmission path, and the company secured a new patent extending protection for GTx-104 to 2043.

Grace Therapeutics announced a Type A meeting with the FDA to clarify the path for GTx-104 NDA resubmission, following a Complete Response Letter in April 2026 that cited CMC and non-clinical issues. The company also reported a net loss of $7.8 million for fiscal year 2026, a decrease from the prior year, and secured a new patent extending GTx-104 protection to 2043. With $17.0 million in cash, Grace Therapeutics believes it has sufficient funds for at least 12 months of operations.

Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.) has filed its Annual Report on Form 10-K for the fiscal year ended March 31, 2026. The company is focusing on developing treatments for rare and orphan diseases, with its lead candidate GTx-104 for aneurysmal subarachnoid hemorrhage (aSAH) being a key priority. While the Phase 3 STRIVE-ON trial for GTx-104 met its primary endpoint, the company received a Complete Response Letter from the FDA in April 2026 due to manufacturing and non-clinical issues, not safety or efficacy concerns. Grace Therapeutics is deferring development of other candidates, GTx-102 and GTx-101, to concentrate resources on GTx-104 and is seeking additional financing.

Grace Therapeutics, Inc. announced that Carrie D Andrea ceased serving as Vice President of Clinical Operations, with her employment ending on June 5, 2026. Ms. D Andrea is expected to execute a separation agreement entitling her to severance benefits consistent with a prior Letter Agreement. Concurrently, she entered into a twelve-month Consulting Agreement with the Company, effective June 5, 2026, to provide services at a rate of $250 per hour. During the consulting term, her stock option awards will continue to vest, and she will have 90 days after the Consulting Agreement's termination to exercise vested options.

Grace Therapeutics, Inc. updated its corporate presentation, revealing it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for GTx-104. The CRL cited deficiencies related to Chemistry, Manufacturing, and Controls (CMC) data package completeness, manufacturing readiness, and nonclinical information, but identified no clinical deficiencies. The company plans to request a Type A meeting with the FDA and intends to resubmit the NDA after resolving the identified issues, which it believes has a clear path to resolution.

Grace Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for GTx-104, developed for aneurysmal subarachnoid hemorrhage (aSAH) patients. The CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections, specifically related to leachables data, toxicology risk assessments, and manufacturing deficiencies. The FDA did not request additional clinical data. The company intends to request a Type A meeting with the FDA to clarify the path forward and plans to resubmit the application after resolving the cited issues.