Scholar Rock Holding Corporation issued a clarification regarding post-marketing requirements for its newly FDA-approved spinal muscular atrophy (SMA) drug, ISEMBYLD™ (apitegromab-mstn). This filing corrects a misstatement made during a September 14, 2026 investor call, where management indicated no such requirements were requested by the FDA.
Key Details
- Corrected Statement: The company is now disclosing that the FDA has outlined post-marketing safety requirements in connection with the approval of ISEMBYLD™.
- FDA Requirements: The FDA requires the company to establish a pregnancy safety study and has also requested the submission of all domestic and foreign fracture cases as 15-day "alert reports."
- Background: The clarification follows the recent announcement of FDA approval for ISEMBYLD™ for the treatment of SMA in adults and children 2 years of age and older.