Scholar Rock Resubmits Apitegromab MAA to EMA, Eyes CHMP Opinion in H1 2027
SRRK sits 56% above its 52-week low of $27.07.
Summary
Scholar Rock resubmitted its Marketing Authorisation Application for apitegromab to the EMA, swapping in the alternate fill-finish facility that supported the U.S. FDA approval of Isembyld in September. The original MAA was withdrawn in August due to GMP compliance issues at the Catalent Indiana site. The company now expects a CHMP opinion in the first half of 2027. This is a concrete step toward European approval for the first muscle-targeted SMA therapy, with U.S. launch already underway.
At the time of this announcement, SRRK was trading at $42.21 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.1B. The 52-week trading range was $27.07 to $61.76. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.