Sarepta Therapeutics, Inc.
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- Sarepta Therapeutics, Inc. (SRPT) is a commercial-stage biopharmaceutical company focused on precision genetic medicines for rare neuromuscular and central nervous system disorders, primarily Duchenne muscular dystrophy (DMD); its core products include FDA-approved RNA-targeted exon-skipping therapies EXONDYS 51 (eteplirsen) for exon 51 skipping, VYONDYS 53 (golodirsen) for exon 53 skipping, and AMONDYS 45 (casimersen) for exon 45 skipping, alongside the gene therapy ELEVIDYS (delandistrogene moxeparvovec-rokl) for DMD patients aged four and older with confirmed DMD gene mutations. The company advances a pipeline of over 40 programs across gene therapy, RNA technology including Morpholino oligomers and siRNA, and gene editing platforms, targeting DMD, limb-girdle muscular dystrophies (LGMDs), myotonic dystrophy type 1 (DM1), facioscapulohumeral muscular dystrophy (FSHD), Huntington's disease, and other rare diseases; it serves patients, healthcare providers, and partners globally through manufacturing facilities and commercialization efforts. Founded in 1980 and headquartered in Cambridge, Massachusetts, with operations including a Genetic Therapies Center of Excellence in Columbus, Ohio, Sarepta targets pediatric and adult patients in the U.S. and select international markets via collaborations such as ex-U.S. rights with Roche. Recent developments include a November 2024 global licensing and collaboration agreement with Arrowhead Pharmaceuticals, providing Sarepta four clinical-stage siRNA programs for DM1, FSHD, and other neuromuscular indications plus three preclinical assets for $500 million upfront, $325 million in Arrowhead equity, and $50 million annual payments over five years, which closed in February 2025 and advanced with a $100 million milestone for the SRP-1003 DM1 program in August 2025. In June 2024, the FDA expanded ELEVIDYS approval to ambulatory and non-ambulatory DMD patients aged four and older, granting traditional approval for non-ambulatory use and accelerated approval for ambulatory; confirmatory ESSENCE study data for additional exon-skipping therapies was completed in Q3 2025, supporting planned supplemental NDA filings. Amid challenges including patient deaths linked to ELEVIDYS prompting a July 2025 restructuring with 36% workforce layoffs for $400 million in 2026 cost savings, and FDA clearance in November 2025 for a study mitigating liver injury risks, Sarepta reported Q3 2025 revenues boosted by $166.9 million in collaboration income from Roche-related milestones and Japanese approvals.
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