Scholar Rock Holding Corporation (SRRK), Tuesday announced the resubmission of Biologics License Application for apitegromab to the U.S. Food and Drug Administration for the treatment of children and adults with spinal muscular atrophy.
The resubmission also includes a second U.S.-based fill-finish facility to strengthen the apitegromab supply chain and support future growing demand across the planned global commercial footprint. This is in line with FDA guidance from the March 3, 2026, Type C meeting.
The company expects the acceptance of BLA resubmission by FDA within 30 days and a review period of up to six months from the date of resubmission. Further, the PDUFA action date is expected in late September 2026.
Meanwhile, the decision from the European Medicines Agency review of the Marketing Authorisation Application for apitegromab is expected in mid-2026.
In the pre-market hours, SRRK is moving up 12.35 percent, to $48.40 on the Nasdaq.
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