Grace Therapeutics’ bid to update the standard of care in aneurysmal subarachnoid hemorrhage hit a regulatory roadblock after the FDA issued a complete response letter for GTx-104. The agency cited manufacturing and nonclinical deficiencies rather than efficacy or safety concerns, delaying the program’s path forward. According to Grace, the CRL raised issues related to leachables for product packaging, nonclinical product toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturing organization. The company said it plans to request a type A meeting with the FDA to clarify a path forward and determine next steps. For investors and clinicians tracking treatments in SAH, the setback highlights how CMC and toxicology packages can become decisive—even when clinical results are positive.