Grace Therapeutics said the FDA issued a complete response letter for its GTx-104 NDA, delaying the company’s attempt to update the standard of care for aneurysmal subarachnoid hemorrhage. Grace reported that the CRL cited manufacturing and nonclinical deficiencies rather than efficacy or safety concerns. The agency pointed to issues including leachables for product packaging, nonclinical product toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturing organization. Grace plans to request a Type A meeting with the FDA to clarify the path forward. Industry impact: the setback underscores how CMC and toxicology documentation can become gating items even when clinical data are positive, forcing teams to re-plan timelines, rework submission components, and adjust investor expectations for rare-neurology indications.