Grace Therapeutics’ lead aneurysmal subarachnoid hemorrhage program hit a regulatory roadblock as the FDA issued a complete response letter for GTx-104. The CRL cited manufacturing and nonclinical deficiencies rather than problems with efficacy or safety. Specifically, the FDA pointed to leachables for product packaging, nonclinical product toxicology risk assessments, and product 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. The company’s setback delays hopes of updating the standard of care in the condition after a positive trial signal. For investors and development teams, the decision underscores how CMC and toxicology packages can become gating items even when clinical data are supportive.