Grace Therapeutics reported a net loss of $15.8 million for the quarter ended June 30, 2026, driven by a $13.5 million impairment of in-process research and development assets related to deprioritized candidates GTx-101 and GTx-102. The company announced a $10 million private placement financing to support manufacturing and regulatory work for its lead asset, GTx-104. Management provided an update on the New Drug Application resubmission strategy following a previous Complete Response Letter from the FDA, outlining a dual-source manufacturing approach involving remediation at the current contract manufacturer and technology transfer to a second U.S.-based facility. Cash and cash equivalents stood at $22.2 million as of August 11, 2026, extending the cash runway through the end of calendar 2028. Grace Therapeutics is a late-stage biopharmaceutical company developing novel drug delivery technologies for rare diseases.

Grace Therapeutics, Inc. announced a private placement of its common stock on August 4, 2026, closing on August 6, 2026. The company sold 4,761,904 shares at $2.10 per share to institutional and accredited investors, generating approximately $10 million in gross proceeds before fees. Craig-Hallum Capital Group LLC acted as the placement agent. Proceeds will support manufacturing and regulatory work for GTx-104, extending the cash runway to the end of calendar 2028. The company initiated a dual-source manufacturing strategy for GTx-104, transferring technology to a second U.S.-based contract manufacturer while remediation efforts continue at the current facility. NDA resubmission timing depends on which manufacturing pathway reaches readiness first. Grace Therapeutics is a late-stage biopharmaceutical company developing novel drug delivery technologies and clinical-stage assets for rare diseases.

Grace Therapeutics, Inc. announced the receipt of FDA meeting minutes from a Type A meeting held on July 28, 2026, regarding the Complete Response Letter issued on April 23, 2026, for its New Drug Application for GTx-104. The FDA did not identify clinical safety or efficacy deficiencies nor request additional clinical data. The CRL items relate to cGMP compliance at the current contract manufacturer's facility, additional leachables data, and excipient toxicology risk assessments. The company plans to address these issues through a dual-source manufacturing strategy, including remediation at the current site and technology transfer to a second-source contract manufacturer in the United States. Grace Therapeutics operates in the biopharmaceutical industry, developing novel drug delivery technologies for rare diseases.

Grace Therapeutics, Inc. updated its corporate presentation on June 18, 2026. The company is a biotechnology company focused on therapeutic solutions.

Grace Therapeutics, Inc. issued a press release on June 18, 2026, announcing its financial results for the fiscal year ended March 31, 2026. The company is in the biotechnology/pharmaceutical industry and develops therapeutic solutions.