Grace Therapeutics said the FDA has issued a complete response letter for its GTx-104 NDA, delaying its effort to update the standard of care in aneurysmal subarachnoid hemorrhage. Grace characterized the CRL as tied to manufacturing and nonclinical deficiencies rather than concerns about efficacy or safety. According to the company, the FDA’s feedback included product-packaging leachables issues, nonclinical product toxicology risk-assessment concerns, and manufacturing deficiencies at its contract manufacturing organization. Grace said it will request a type A meeting with the FDA to clarify the path forward and determine next steps. For Grace, the CRL resets timelines for any potential re-submission, while also shifting near-term focus toward CMC remediation and additional nonclinical work. The setback is notable because subarachnoid hemorrhage is a high-acuity indication where companies often face narrow windows to establish regulatory readiness. The outcome reinforces that even when clinical signals are positive, FDA reviews for new therapeutics can be driven decisively by quality-system execution and the completeness of nonclinical evidence packages.