Sarepta Therapeutics Settles Patent Litigation with REGENXBIO/UPenn

What Happened

• On September 23, 2026, Sarepta Therapeutics (with Sarepta Three) entered a Settlement Agreement with REGENXBIO, the Trustees of the University of Pennsylvania (UPenn) and Catalent to resolve pending patent infringement litigation and an appeal related to U.S. Patents No. 11,680,274, 10,526,617 and 9,198,984 (the “UPenn Patents”) concerning the AAVrh74 capsid.
• Under the agreement, Sarepta will pay REGENXBIO a $39.0 million lump sum within ten days of the effective date. REGENXBIO and UPenn released Sarepta, Catalent and affiliates from infringement claims relating to any Sarepta gene therapy product using the AAVrh74 capsid (including ELEVIDYS) arising up to and including the effective date and agreed not to sue on such claims going forward. REGENXBIO also agreed not to sue over REGENXBIO-owned/controlled patents that cover the existing form of ELEVIDYS or the AAVrh74 capsid sequence. The litigations will be dismissed, withdrawn or otherwise disposed of with prejudice. Each party will bear its own costs; no admission of liability was made.

Key Details

• Effective date: September 23, 2026; lump-sum payment: $39.0 million (due within 10 days).
• Patents involved: U.S. Patent Nos. 11,680,274; 10,526,617; 9,198,984 and certain related patents.
• Release/covenant: Covers Sarepta gene therapy products using the AAVrh74 capsid, including ELEVIDYS; REGENXBIO/UPenn agreed not to sue Sarepta, Catalent, licensees or permitted assigns on those claims.
• Financials: Sarepta previously recorded a $39.0 million litigation contingency charge in its 10-Q for the quarter ended June 30, 2026 related to this anticipated settlement.

Why It Matters

• The settlement removes a major legal overhang tied to the AAVrh74 capsid and ELEVIDYS, reducing the risk of injunctions or additional damages from these specific UPenn/REGENXBIO claims.
• The $39.0M payment matches the charge Sarepta already recorded, so the settlement is unlikely to create a new one-time earnings surprise beyond that reserve.
• Investors should watch Sarepta’s upcoming Form 10-Q for the quarter ending September 30, 2026, where the full Settlement Agreement will be filed as an exhibit for complete terms.