India, June 16 -- Shares of Sarepta Therapeutics Inc. (SRPT) are down over 37% at $22 in premarket trading Monday, following a second fatal case linked to its Duchenne gene therapy ELEVIDYS.
ELEVIDYS is an adeno-associated virus vector-based gene therapy that is approved for the treatment of patients at least 4 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene, regardless of ambulation. Use in non-ambulatory people was approved by the FDA under accelerated approval.
The company initially reported the first patient death tied to ELEVIDYS in March 2024, which was also attributed to acute liver failure. Both fatalities have occurred in non-ambulatory DMD patients, raising significant safety concern...