RegulatoryApr 27, 2026, 07:12 AM
GRCE Receives FDA CRL for GTx-104; Plans NDA Resubmission
AI Summary
Grace Therapeutics, Inc. updated its corporate presentation, revealing it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for GTx-104. The CRL cited deficiencies related to Chemistry, Manufacturing, and Controls (CMC) data package completeness, manufacturing readiness, and nonclinical information, but identified no clinical deficiencies. The company plans to request a Type A meeting with the FDA and intends to resubmit the NDA after resolving the identified issues, which it believes has a clear path to resolution.
Key Highlights
- GRCE received an FDA Complete Response Letter (CRL) for its GTx-104 New Drug Application.
- CRL cited deficiencies in Chemistry, Manufacturing, and Controls (CMC) data package completeness and manufacturing readiness.
- No clinical deficiencies were identified for GTx-104 in the CRL.
- Company plans to request a Type A meeting with FDA to clarify the path forward.
- GRCE intends to resubmit the NDA for GTx-104 after resolving the cited issues.
- CRL noted cGMP inspection deficiencies at the contract manufacturing organization (CDMO).
- GTx-104 holds Orphan Drug Status, providing seven-year market exclusivity.
Price Impact
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