2026-03-31 11:15:28
Scholar Rock Resubmits Biologics License Application for Apitegromab to FDA
Expected Stock impact: Very Positive
On March 31, 2026, Scholar Rock Holding Corporation announced the resubmission of its biologics license application (BLA) for apitegromab, a treatment aimed at children and adults with spinal muscular atrophy (SMA). This significant step follows a complete response letter received from the FDA in September 2025, which was related to observations made during a routine inspection of the Catalent Indiana facility. The resubmission includes plans for a second U.S.-based fill-finish facility, which aligns with FDA guidance from a recent Type C meeting. Scholar Rock anticipates FDA acceptance of the BLA within 30 days and a review period of up to six months, with a Prescription Drug User Fee Act (PDUFA) action date expected in late September 2026. The company is optimistic about the FDA's engagement and is committed to advancing its mission for the SMA community. A conference call is scheduled for today at 8:00 AM ET to discuss this update further.
