Sarepta Therapeutics, Inc. (NASDAQ: SRPT) shares closed at $160.72, up by $37.22 (30.14%) at 4:00 PM EDT. In after-hours trading, the stock increased by $1.74 (1.08%), reaching $162.46 as of 7:59 PM EDT. The day’s trading range was between $157.25 and $173.25, while the 52-week range was $55.25 to $173.25. The trading volume was 14,343,793 shares, significantly higher than the average volume of 1,353,370 shares. Sarepta’s market capitalization during intraday trading stood at $15.192 billion. The stock has a beta of 0.95 over a five-year monthly period, a PE ratio of 373.77, and earnings per share (EPS) of 0.43.
Shares of Sarepta Therapeutics surged by approximately 37% on Friday following the U.S. Food and Drug Administration’s (FDA) expanded approval for its gene therapy, Elevidys, designed for patients with Duchenne muscular dystrophy (DMD). This new approval extends the therapy’s use to patients aged four and older who can walk and grants accelerated approval for those who cannot.
William Blair analyst Tim Lugo projects Elevidys could generate sales of $3 billion in 2025, peaking at $5 billion in 2027 due to this broader approval. Lugo noted that many patients under the age of four, who are not yet diagnosed, will eventually qualify for treatment, significantly expanding the market for Elevidys.
In 2023, Elevidys achieved sales of $200.4 million, with expectations to rise to $991.91 million this year, according to LSEG data. Duchenne muscular dystrophy, a genetic disorder causing progressive muscle degeneration, affects roughly one in every 3,500 male births globally.
Despite the promising demand and acceptable safety profile of Elevidys, analysts have raised concerns about potential manufacturing and supply chain issues that could limit its availability. According to BMO Capital analyst Kostas Biliouris, the addressable patient population in the U.S. is now approximately 13,000, representing nearly 90% of all DMD patients. Biliouris anticipates Elevidys will dominate the DMD gene therapy market, with no significant competition expected until after 2027.
While RegenxBio is in early to mid-stage trials for a competing gene therapy, Pfizer’s recent late-stage study for a DMD treatment failed. Research firm ResearchandMarkets projects that the global DMD treatment market, including gene therapies and other drugs, will grow to $11.47 billion by 2034.
Sarepta will hold an investor call at 8:30 am ET to discuss the expanded approval. Currently, Elevidys is among the world’s most expensive treatments, listed at $3.2 million. On Friday, Sarepta’s price-to-tangible-book-value ratio stood at 12.52, compared to 1.49 for RegenxBio.
