Shares of Sarepta Therapeutics SRPT fell nearly 10% over the past week. This decline likely reflects growing investor concerns about the company’s position in the Duchenne muscular dystrophy (DMD) landscape following a key regulatory milestone for rival Dyne Therapeutics DYN.
On Monday, DYN announced that the FDA accepted its regulatory filing seeking approval for the DMD therapy zeleciment rostudirsen (z-rostudirsen, or DYNE-251). The application was granted priority review, with the agency expected to make a final decision by Jan. 21, 2027. If approved, the Dyne Therapeutics drug could emerge as a competitive threat to Sarepta’s Exondys 51, as both therapies target DMD patients amenable to exon 51 skipping.
Exondys 51, approved in 2016, was the first FDA-approved treatment for DMD patients amenable to exon 51 skipping and remains the standard of care for this patient population. However, z-rostudirsen could challenge its market position if approved. Unlike Sarepta’s drug, which requires once-weekly infusions, Dyne’s drug is administered once every four weeks, potentially offering greater convenience for patients and caregivers. Analysts also point to cross-study comparisons suggesting that z-rostudirsen achieved higher dystrophin expression than Exondys 51, further strengthening its competitive profile.
The latest development comes as Sarepta shares were beginning to stabilize following a steep selloff triggered by safety concerns surrounding the company's DMD gene therapy, Elevidys. Investor sentiment deteriorated after two patient deaths following treatment with Elevidys prompted the FDA to significantly restrict the therapy's label to ambulatory DMD patients and add a boxed warning for acute liver injury. With Elevidys representing a key growth driver for Sarepta, the regulatory setback had already raised concerns about the company's growth outlook. Against this backdrop, Dyne's regulatory progress has added to investor concerns about Sarepta's competitive position in DMD.
Growing Competition in the DMD Space
Apart from Dyne Therapeutics, Sarepta faces competition from several other emerging players. These include Regenxbio RGNX, Wave Life Sciences WVE and Solid Biosciences, which are developing next-generation RNA or gene therapy approaches for the treatment of DMD.
SRPT’s Price Performance, Valuation & Estimates
Shares of Sarepta have underperformed the industry year to date, as seen in the chart below.
Image Source: Zacks Investment Research
From a valuation standpoint, Sarepta is at a discount to the industry. Based on the price/book (P/B) ratio, the company’s shares currently trade at 1.14 times trailing book value, lower than the industry’s average of 3.44.
Image Source: Zacks Investment Research
Over the past 30 days, the Zacks Consensus Estimate for 2026 EPS has declined from $4.84 to $4.77, while that for 2027 has fallen from $3.02 to $2.90.
Image Source: Zacks Investment Research
Sarepta currently has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Sarepta Therapeutics, Inc. (SRPT): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).