Scholar Rock resubmits EMA marketing authorisation for apitegromab with new fill‑finish site
Scholar Rock filed a revised Marketing Authorisation Application for its SMA therapy apitegromab with the European Medicines Agency, replacing the previously cited Catalent Indiana fill‑finish facility with an alternate U.S. site. The company withdrew the earlier EU filing in August 2026 after a GMP compliance issue and now expects a CHMP opinion in the first half of 2027. The therapy, approved in the United States as ISEMBYLD in September 2026, is the first muscle‑targeted treatment to show motor‑function improvement in SMA patients on SMN2‑targeted therapy.
Why it matters
The company says it expects the EMA’s CHMP to issue an opinion in H1 2027, which could open a European market of roughly 35,000 SMA patients currently on SMN‑targeted treatments. Approval would broaden revenue beyond the U.S. launch.
Key facts
- 1Scholar Rock withdrew its previous European application in August 2026 due to lack of GMP compliance at the Catalent Indiana fill‑finish facility. investing.com
- 2The resubmitted MAA includes an alternate U.S.-based fill‑finish facility that supported the U.S. FDA approval of ISEMBYLD on September 11 2026. biospace.com
- 3The company anticipates a CHMP opinion in the first half of 2027. tradingview.com
- 4SRRK shares were trading at $41.48, down 1.71%, after the filing announcement. rttnews.com
- 5SRRK shares were down 0.47% in pre‑market trading following the news. rttnews.com
Summary written by AlphAI from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.