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Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA)

SRRK
  • The July 2026 CHMP meeting commenced today to review the apitegromab marketing authorisation application (MAA) for Scholar Rock.
  • The expected CHMP opinion for apitegromab depends on the FDA's inspection classification status for the Catalent Indiana LLC fill-finish facility.
  • If the FDA reclassifies the Catalent Indiana facility, a CHMP opinion is anticipated later in 2026.
  • Should the Catalent Indiana facility not be reclassified, Scholar Rock plans to work with the EMA to include its second U.S.-based fill-finish facility in the MAA.
  • The second fill-finish facility is included in the U.S. Biologics License Application (BLA) with a September 30, 2026 PDUFA action date.
  • Scholar Rock will provide a regulatory update during its second quarter earnings call on Thursday, August 6, 2026.
  • Scholar Rock's second facility is currently in good standing with both the FDA and EMA.