Grace Therapeutics, Inc.

Grace Therapeutics reported a net loss of $15.8 million, or $0.91 per share, for the three months ended June 30, 2026, significantly higher than the prior year due to a $13.5 million impairment of IPR&D for deprioritized assets. The company announced a $10 million private placement financing and is making progress on its GTx-104 New Drug Application (NDA) resubmission, addressing FDA's Complete Response Letter items with a dual-source manufacturing strategy. The financing extends its cash runway through the end of 2028.

Grace Therapeutics reported a net loss of $(15.79) million for the quarter ended June 30, 2026, significantly wider than the prior year, primarily due to a $(13.53) million impairment charge on intangible assets for GTx-101 and GTx-102. The company is now focused on its lead product candidate, GTx-104, following an FDA Complete Response Letter. Grace Therapeutics recently completed a private placement, raising approximately $9.1 million, and expects its current cash to fund operations for at least 12 months, though additional financing will be required.

Grace Therapeutics, Inc. announced a private placement financing expected to generate approximately $10 million in gross proceeds. The company will issue 4,761,904 shares of common stock at $2.10 per share to new and existing investors. The net proceeds will be used to support manufacturing and regulatory work for GTx-104, extending the company's cash runway to the end of 2028. Additionally, Grace Therapeutics has initiated a dual-source manufacturing strategy for GTx-104 to mitigate potential remediation issues and provide flexibility for its New Drug Application resubmission.

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.