Quarterly ResultJun 18, 2026, 08:07 AM
Grace Therapeutics FY26 Net Loss $7.8M; FDA CRL for GTx-104 NDA
AI Summary
Grace Therapeutics announced its financial results for the fiscal year ended March 31, 2026, reporting a net loss of $7.8 million, a decrease from $9.6 million in the prior year. The company also provided a business update, including the receipt of a Complete Response Letter (CRL) from the FDA in April 2026 for its GTx-104 NDA, citing Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical issues. A Type A meeting with the FDA is scheduled to clarify the resubmission path, and the company secured a new patent extending protection for GTx-104 to 2043.
Key Highlights
- FDA issued a Complete Response Letter (CRL) for GTx-104 NDA in April 2026, citing CMC and Non-Clinical issues.
- A Type A meeting with the FDA is scheduled to clarify the path for GTx-104 NDA resubmission.
- Net loss for fiscal year 2026 was $7.8 million, a $1.8 million decrease from $9.6 million in fiscal year 2025.
- Research and development expenses decreased by $7.1 million to $2.4 million in fiscal year 2026.
- General and administrative expenses increased by $1.5 million to $8.7 million in fiscal year 2026.
- Cash and cash equivalents were $17.0 million at March 31, 2026, down from $22.1 million.
- New U.S. Patent No. 12,414,943 for GTx-104 extends protection to 2043.
- Company believes existing cash will sustain operations for at least 12 months.
Price Impact
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