Street View: Sarepta's Elevidys label update in line with expectations

Sarepta Therapeutics

17/11/2025 13:46

** The U.S. FDA on Friday approved new prescribing information for Sarepta Therapeutics' SRPT.O muscle disorder gene therapy, Elevidys, adding its most serious boxed warning for the risk of acute serious liver injury and liver failure and restricting its use to walking patients with Duchenne muscular dystrophy

** Nine of 29 brokerages rate the stock "buy" or higher, 15 "hold" and 5 "sell" or lower; their median PT is $18 - data compiled by LSEG

NO SURPRISES

** TD Cowen ("hold", PT: $17) says the label update is in line with expectations and includes guidelines that will not be onerous to treatment

** "We believe the label's recommendations... will provide physicians with strategies to more comfortably and safely dose Elevidys and further reduce the risk of liver and immune serious adverse events" - TD Cowen

** Uncertainty remains on whether FDA has formally revoked accelerated approval for non-ambulatory DMD or if the indication could be reinstated at the agency's discretion, brokerage says

** Jefferies ("buy", PT: $30) says the label update came with "no surprises" and expects stock to "climb higher if quarterly sales re-accelerate, instilling investor confidence uptake will remain durable"

** H.C. Wainwright ("sell", PT: $5) says FDA’s sweeping label changes shrink Elevidys’s addressable market and add heavy monitoring burden that will slow uptake

** New contraindications and post-marketing study will further deplete patient pool, reinforcing negative regulatory trajectory, brokerage says

(Reporting by Sahil Pandey in Bengaluru)

((Sahil.Pandey@thomsonreuters.com))