Grace Therapeutics faced a regulatory setback for its aneurysmal subarachnoid hemorrhage program despite earlier positive trial results. The FDA issued a complete response letter (CRL) for the company’s GTx-104 NDA, pointing to manufacturing and nonclinical deficiencies rather than efficacy or safety concerns. The CRL cited issues including leachables for product packaging, nonclinical product toxicology risk assessments, and manufacturing deficiencies at the company’s 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 a development-stage company pursuing a potentially practice-changing update in an area with limited modern therapeutic options, the CRL shifts attention from clinical efficacy to quality systems and evidence packaging. Execution risk now centers on resolving CMC and nonclinical documentation to re-enter a review timeline acceptable to regulators.