Grace Therapeutics announced its third quarter fiscal 2026 financial results for the period ended December 31, 2025, reporting a net loss of $2.3 million. The company also provided a business update, highlighting the FDA's PDUFA target date of April 23, 2026, for its NDA for GTx-104 in the treatment of aneurysmal subarachnoid hemorrhage.
Key takeaways
The FDA established a PDUFA target date of April 23, 2026, for its review of the NDA submission for GTx-104 for the treatment of aSAH.
The company reported a net loss of $2.3 million, or $0.14 per share, for the three months ended December 31, 2025, a decrease from a net loss of $4.2 million for the same period in 2024.
As of December 31, 2025, cash and cash equivalents were $18.7 million, which the company believes is sufficient to sustain planned operations for at least 12 months from February 12, 2026.
The Phase 3 STRIVE-ON safety trial for GTx-104 met its primary endpoint, showing a 19% reduction in clinically significant hypotension compared to oral nimodipine.
On October 23, 2025, the company secured approximately $4.0 million in additional funding through the exercise of common warrants.