GRCE · Grace Therapeutics, Inc.

Grace Therapeutics announced that the FDA issued a Complete Response Letter for its New Drug Application for GTx-104, an IV formulation of nimodipine for aneurysmal subarachnoid hemorrhage patients. The CRL specifically references issues in Chemistry, Manufacturing, and Controls (leachables data for packaging, manufacturing deficiencies at contract manufacturing organization) and non-clinical sections (product toxicology risk assessments), but notably does not require additional clinical data. This positions the company to address these technical deficiencies and resubmit, with intentions to request a Type A meeting for clarification. The underlying STRIVE-ON trial data remains a strength, demonstrating superiority over oral nimodipine in reducing clinically significant hypotension (28% vs 35% incidence), achieving higher relative dose intensity (54% of patients at 95%+ vs 8%), and favorable 90-day functional outcomes (29% more patients). Secondary benefits included fewer ICU readmissions, ICU days, and ventilator days, with comparable adverse events and no drug-related deaths. For investors, this CRL represents a regulatory setback but one focused on manufacturability rather than efficacy or safety, preserving the potential for GTx-104 to become the first innovation in aSAH treatment in over 40 years if resubmission succeeds. The Orphan Drug Designation adds market exclusivity value upon approval.