RegulatoryJun 18, 2026, 08:01 AM
Grace Therapeutics Schedules FDA Meeting for GTx-104 NDA Resubmission
AI Summary
Grace Therapeutics announced a Type A meeting with the FDA to clarify the path for GTx-104 NDA resubmission, following a Complete Response Letter in April 2026 that cited CMC and non-clinical issues. The company also reported a net loss of $7.8 million for fiscal year 2026, a decrease from the prior year, and secured a new patent extending GTx-104 protection to 2043. With $17.0 million in cash, Grace Therapeutics believes it has sufficient funds for at least 12 months of operations.
Key Highlights
- FDA Type A meeting scheduled to clarify GTx-104 NDA resubmission path after April 2026 CRL.
- New U.S. Patent No. 12,414,943 issued, extending GTx-104 IV dosing regimen protection to 2043.
- Fiscal Year 2026 net loss was $7.8 million, a $1.8 million decrease from prior year.
- R&D expenses decreased by $7.1 million to $2.4 million in FY2026.
- G&A expenses increased by $1.5 million to $8.7 million in FY2026.
- Cash and cash equivalents were $17.0 million as of March 31, 2026, providing 12+ months of runway.
- Phase 3 STRIVE-ON trial showed GTx-104 reduced hypotension by 19% vs. oral nimodipine.
Price Impact
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