CAMBRIDGE, Mass. — Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today provided an update on the anticipated timing of a Committee for Medicinal Products for Human Use (CHMP) opinion for the apitegromab marketing authorisation application (MAA) for children and adults with spinal muscular atrophy (SMA). The European Medicines Agency (EMA) is reviewing the apitegromab MAA, which includes the Catalent Indiana LLC (part of Novo Nordisk) fill-finish facility, and is awaiting an update on the inspection classification of Catalent Indiana from the FDA following an April 2026 general site inspection.
Should the FDA reclassify Catalent Indiana, a CHMP opinion would be expected later in 2026. In the event that Catalent Indiana is not reclassified, Scholar Rock will work with the EMA to advance the apitegromab MAA with the Company’s second fill-finish facility, which is included in the apitegromab Biologics License Application (BLA) under FDA review in the U.S. with a September 30, 2026 Prescription Drug User Fee Act (PDUFA) action date. The Company will provide an update during its second quarter earnings call on Thursday, August 6, 2026.
“We are very pleased with the EMA’s review of the apitegromab MAA and with the level of engagement we have from the Agency,” said David L. Hallal, Board Chair and Chief Executive Officer of Scholar Rock. “We expect clarity from the FDA on the inspection classification of Catalent Indiana in the near term, and we remain confident in our ability to advance our MAA through the EMA review process either with Catalent Indiana or by taking the necessary steps to include our second fill-finish facility.”
Scholar Rock’s second fill-finish facility for apitegromab is a U.S.-based facility producing numerous commercial products and is in good standing with both the FDA and EMA.
About Scholar Rock
Scholar Rock is a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Scholar Rock® is a registered trademark of Scholar Rock, Inc.
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Scholar Rock Contacts
Investors
Laura Ekas, Ph.D.
[email protected]
917-439-0374
Media
Jeff Smith
682-401-8428
Molly MacLeod, Ph.D.
802-579-5995
[email protected]