Grace Therapeutics Narrows 2026 Net Loss, Schedules FDA Type A Meeting for GTx-104
GRCE•Grace Therapeutics posted a fiscal 2026 net loss of $7.8 million, down from $9.6 million in 2025, and held $17.0 million cash, funding 12 months of operations. It scheduled a Type A meeting with the FDA to resolve CMC and non-clinical issues in the GTx-104 NDA Complete Response Letter.
1. Fiscal 2026 Financial Results
Grace Therapeutics reported a net loss of $7.8 million (-$0.47/share) for the fiscal year ended March 31, 2026, versus a $9.6 million (-$0.79/share) loss a year earlier. Research and development expenses declined to $2.4 million from $9.5 million due to the Phase 3 STRIVE-ON closeout, while general and administrative costs increased to $8.7 million driven by legal, consulting and pre-commercial planning; cash and cash equivalents totaled $17.0 million, sufficient for at least 12 months of operations.
2. FDA Complete Response Letter and Next Steps
On April 23, 2026, the FDA issued a Complete Response Letter for the GTx-104 NDA, citing Chemistry, Manufacturing and Controls (CMC) and non-clinical items but no clinical deficiencies. Grace Therapeutics has scheduled a Type A meeting to address additional leachable data requirements, non-clinical toxicology risk assessments and cGMP deficiencies and will issue a regulatory update after receiving official meeting minutes.
3. Intellectual Property and Pre-Commercial Planning
Grace secured U.S. Patent No. 12,414,943 for intravenous nimodipine dosing, extending GTx-104 patent protection to 2043; its formulation patents run through 2037. The injectable nimodipine holds Orphan Drug Designation, offering seven years of U.S. marketing exclusivity upon approval, and the company continues disciplined pre-commercial activities in anticipation of potential FDA approval.
