earnings
confidence high
sentiment negative
materiality 0.75
Grace Therapeutics FY2026 net loss $7.8M; FDA CRL for GTx-104; Type A meeting set
Grace Therapeutics, Inc.
- Net loss of $7.8M ($0.47 loss per share) for FY2026, improved from $9.6M loss in FY2025.
- Cash and equivalents $17.0M at March 31, 2026; expected to fund operations at least 12 months.
- FDA issued Complete Response Letter for GTx-104 NDA in April 2026; no clinical deficiencies cited; Type A meeting scheduled.
- Phase 3 STRIVE-ON trial met primary endpoint; 19% reduction in clinically significant hypotension vs oral nimodipine.
- New U.S. patent (No. 12,414,943) for IV dosing regimen extends GTx-104 IP protection to 2043.