Sarepta settles patent litigation with REGENXBIO, UPenn, Catalent over gene therapy capsid

Sarepta Therapeutics, Sarepta Therapeutics Three, REGENXBIO, the Trustees of the University of Pennsylvania and Catalent entered a settlement agreement on September 23, 2026, resolving pending patent infringement litigations and an appeal from inter partes review proceedings relating to U.S. Patent No. 11,680,274 and U.S. Patent No. 10,526,617¹.

The financial terms match what Sarepta had already flagged. The company had disclosed in its Form 10-Q for the quarter ended June 30, 2026 that it recorded a litigation contingency charge of $39.0 million related to the anticipated settlement.¹ Under the settlement, Sarepta will pay REGENXBIO a lump sum of $39.0 million within ten days of the September 23, 2026 effective date.¹

In exchange, REGENXBIO and UPenn released Sarepta, Catalent and their affiliates from any claims relating to any Sarepta gene therapy product that uses the AAVrh74-based capsid, including ELEVIDYS, covering infringement claims on the two patents plus U.S. Patent No. 9,198,984 and certain related patents, arising up to the effective date.¹ Going forward, REGENXBIO and UPenn agreed not to sue Sarepta, Catalent or their current affiliates, licensees, commercial partners, successors and permitted assigns over infringement of those patents tied to any Sarepta gene therapy product using an AAVrh74-based capsid, including ELEVIDYS.¹ REGENXBIO also agreed not to sue Sarepta or its licensees, commercial partners, successors and permitted assigns over any REGENXBIO-controlled or owned patents covering the existing form of ELEVIDYS or the AAVrh74 capsid sequence.¹

The agreement provides for dismissal of the litigations with prejudice, with each party bearing its own costs and fees, and includes no admission of liability or wrongdoing by any party.¹ Sarepta said it intends to file the complete settlement agreement as an exhibit to its Form 10-Q for the quarter ending September 30, 2026.¹