newsfilter
← Latest News
Business Wire·

Scholar Rock Reports Third Quarter 2026 Financial Results and Recent Business Highlights

SRRK
  • Scholar Rock received FDA approval for ISEMBYLD (apitegromab-mstn) on September 11, 2026, marking the first muscle-targeted therapy for spinal muscular atrophy (SMA) in children and adults.
  • The U.S. commercial launch of ISEMBYLD began in October 2026 with strong early demand from patients and physicians, generating $0.6 million in Q3 2026 revenue.
  • The company resubmitted its Marketing Authorisation Application (MAA) for apitegromab to the European Medicines Agency (EMA) in October 2026, targeting a CHMP opinion in the first half of 2027.
  • A Japanese New Drug Application (JNDA) for apitegromab was accepted by the PMDA under priority review, with a typical nine-month review cycle expected.
  • Scholar Rock entered a definitive agreement in November to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $205 million, with closing subject to HSR Act waiting period expiration.
  • Cash, cash equivalents, and marketable securities totaled $413.6 million as of September 30, 2026.
  • The company reported a net loss of $107.2 million for the quarter ended September 30, 2026, compared to $102.2 million in the prior year quarter.
  • The Phase 3 SAPPHIRE study demonstrated that ISEMBYLD provided robust motor function improvement at one year when combined with SMN2-targeted therapy.
  • Ongoing development includes the Phase 2 OPAL trial for infants under two years, the Phase 2 FORGE trial for facioscapulohumeral muscular dystrophy (FSHD), and the Phase 1 SRK-439 subcutaneous program.
  • A J-code application for ISEMBYLD was submitted to CMS in September, with a potential effective date of April 1, 2027.