Grace Therapeutics received a US FDA complete response letter for its GTx-104 NDA for aneurysmal subarachnoid hemorrhage, delaying the company’s push to update the standard of care. The FDA cited manufacturing and nonclinical deficiencies rather than concerns about efficacy or safety. In particular, the CRL flagged leachables for product packaging, gaps in nonclinical product toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturing organization. Grace said it plans to request a type A meeting with the FDA to clarify a path forward. For investors and clinicians, the key takeaway is that a drug’s clinical momentum can be stalled by CMC and toxicology completeness—underscoring the scrutiny placed on late-stage readiness for difficult, time-sensitive neurologic indications.