Grace Therapeutics Reports Fiscal Year 2026 Results and Provides Update on GTx-104 NDA Status

Grace Therapeutics, Inc. reported financial results for the fiscal year ended March 31, 2026, and provided a regulatory update on its lead asset, GTx-104. The company reported a net loss of $7.8 million ($0.47 per share), a decrease from $9.6 million in the prior year. Research and development expenses significantly dropped to $2.4 million following the completion of the Phase 3 STRIVE-ON safety trial. As of March 31, 2026, the company held $17.0 million in cash, which it believes is sufficient to fund operations for at least 12 months. On the regulatory front, the FDA issued a Complete Response Letter (CRL) on April 23, 2026, regarding the NDA for GTx-104 for aneurysmal Subarachnoid Hemorrhage (aSAH). The CRL cited CMC and non-clinical issues, including leachable data, toxicology risk assessments, and cGMP deficiencies at a contract manufacturer, but no clinical deficiencies. Grace has scheduled a Type A meeting with the FDA to clarify the path for an NDA resubmission. Additionally, the company secured a new method-of-use patent extending intellectual property protection for GTx-104 to 2043.