Sarepta's Elevidys Gene Therapy Approved by FDA Despite Staff Opposition; BofA Raises Price Objective to $213

Jun 20, 2024, 09:49 PM

Sarepta Therapeutics (SRPT) has received full approval from the FDA for its gene therapy, Elevidys, despite opposition from the review staff. The decision was made by CBER Director Peter Marks, who overruled the recommendations for a complete response letter (CRL) from the FDA's Office of Tissues and Advanced Therapies (OTP) directors Lola Fashoyin-Aje and Nicole Verdun. This approval is seen as a significant boost for Sarepta, with BofA raising its price objective from $166 to $213. The decision has sparked discussions about the FDA's regulatory approach, particularly in the context of recent challenges in the Duchenne muscular dystrophy (DMD) space. Sarepta also saw early buyers of 500 June 28th $120/$155 call spreads for $14.60.