Grace Therapeutics reports fiscal 2026 results
- Grace Therapeutics (NASDAQ:GRCE) reported a net loss of $7.8 million for fiscal 2026, an improvement from the $9.6 million loss recorded in 2025.
- The company is scheduling a Type A meeting with the FDA to address a Complete Response Letter received in April 2026 for its drug candidate, GTx-104.
- With $17 million in cash as of March 31, 2026, Grace Therapeutics expects its current funding to support operations for at least 12 months.
Grace Therapeutics (NASDAQ:GRCE) announced its financial results for the fiscal year ended March 31, 2026, alongside a regulatory update regarding its lead candidate, GTx-104.
The company narrowed its annual net loss to $7.8 million, compared to $9.6 million in the prior fiscal year, as research and development expenses decreased to $2.4 million following the conclusion of the STRIVE-ON trial.
The April 2026 regulatory letter cited deficiencies related to chemistry, manufacturing, and controls (CMC), non-clinical information, and cGMP inspections, while noting no clinical or efficacy deficiencies.
Grace Therapeutics maintains Orphan Drug Designation for GTx-104 and stated that its current patent estate provides intellectual property coverage extending to 2043.
Following the announcement, the Grace Therapeutics share price was $2.22.
The company focuses on developing novel, injectable formulations of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage, a rare type of stroke.
Grace Therapeutics continues to progress its pre-commercial planning efforts while preparing for its upcoming Type A meeting with the FDA to finalize the path for its New Drug Application resubmission.
