Sarepta Therapeutics, Inc. filed an 8-K on September 23, 2026, disclosing that it entered into a settlement agreement with REGENXBIO Inc., the Trustees of the University of Pennsylvania, and Catalent, Inc. to resolve pending patent infringement litigations related to two U.S. patents.

Key Highlights

  • Settlement payment: Sarepta will pay REGENXBIO a lump sum of $39.0 million within ten days of the September 23, 2026 effective date.
  • Prior charge recorded: Sarepta had already recorded a litigation contingency charge of $39.0 million in the three and six months ended June 30, 2026, related to the anticipated settlement.
  • Patents at issue: The litigations involved U.S. Patent No. 11,680,274 and U.S. Patent No. 10,526,617, plus related inter partes review proceedings.
  • Release of claims: REGENXBIO and UPenn released Sarepta, Catalent, and their affiliates from infringement claims under the UPenn Patents for any Sarepta gene therapy product using the AAVrh74-based capsid, including ELEVIDYS, arising up to and including the effective date.
  • Future covenant not to sue: REGENXBIO and UPenn agreed not to sue Sarepta or specified affiliates regarding the UPenn Patents as they relate to any AAVrh74-based capsid Sarepta gene therapy product, including ELEVIDYS.
  • No admission of liability: According to the filing, "The Settlement Agreement does not include any admission of liability or wrongdoing by any party."
  • Dismissal of litigations: The settlement provides for dismissal, withdrawal, or other disposal of the litigations with prejudice, with each party bearing its own costs and attorneys' fees.

Sarepta Resolves AAVrh74 Patent Litigations with REGENXBIO, UPenn, and Catalent

On September 23, 2026, Sarepta Therapeutics, Inc. (NASDAQ:SRPT), through itself and its subsidiary Sarepta Therapeutics Three, LLC, entered into a settlement agreement with REGENXBIO Inc., the Trustees of the University of Pennsylvania, and Catalent, Inc., according to the 8-K filed that same day. The settlement resolves pending patent infringement litigations and an appeal from inter partes review proceedings concerning U.S. Patent No. 11,680,274 and U.S. Patent No. 10,526,617.

The company disclosed that the $39.0 million lump-sum payment to REGENXBIO had been anticipated: Sarepta had already recorded a litigation contingency charge of that amount in the three and six months ended June 30, 2026, as disclosed in its Quarterly Report on Form 10-Q for the period then ended. The payment is due within ten days of the September 23, 2026 effective date. In exchange, REGENXBIO and UPenn released Sarepta, Catalent, and their affiliates from claims of infringement of the UPenn Patents, which include the two litigated patents as well as U.S. Patent No. 9,198,984 and certain related patents, for any Sarepta gene therapy product using an AAVrh74-based capsid, including ELEVIDYS, for claims arising at any time up to and including the effective date.

The settlement also includes a forward-looking covenant: REGENXBIO and UPenn agreed not to sue Sarepta, Catalent, or their current affiliates, licensees, commercial partners, successors, and permitted assigns for patent infringement of the UPenn Patents to the extent infringement arises from an AAVrh74-based capsid Sarepta gene therapy product, including ELEVIDYS. REGENXBIO separately agreed not to sue Sarepta or its licensees, commercial partners, successors, and permitted assigns regarding any REGENXBIO-controlled or owned patents or patent applications covering the existing form of ELEVIDYS or the AAVrh74 capsid sequence. The company stated the full settlement agreement will be filed as an exhibit to its Form 10-Q for the quarter ending September 30, 2026.

What Was Disclosed

Sarepta Therapeutics disclosed a $39.0 million patent settlement with REGENXBIO, UPenn, and Catalent, resolving litigations over two U.S. patents related to its AAVrh74-based gene therapy products, including ELEVIDYS, with no admission of liability by any party.