Grace Therapeutics received an FDA complete response letter for its GTx-104 NDA, pausing plans to update the standard of care in aneurysmal subarachnoid hemorrhage. The agency cited manufacturing and nonclinical deficiencies rather than concerns about efficacy or safety. Grace pointed to issues including leachables for product packaging, nonclinical product toxicology risk assessments, and manufacturing deficiencies at its contract manufacturing organization. The company said it will request a type A meeting to clarify the regulatory path and determine next steps. The setback highlights how CMC and toxicology documentation can become the primary gating items for NDA progress even when clinical signals are viewed positively by developers.