REGENXBIO, UPenn settle patent suit with Sarepta over ELEVIDYS

REGENXBIO Inc. disclosed in an 8-K filing that on September 23, 2026, the company and The Trustees of the University of Pennsylvania reached a settlement with Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc. The agreement resolves all patent infringement litigation alleging infringement of U.S. Patent No. 10,526,617 and U.S. Patent No. 11,680,274, tied to Sarepta's manufacture, use, offer to sell and sale of SRP-9001, also known as ELEVIDYS in the U.S.¹

Under the deal, Sarepta agreed to pay REGENXBIO $39.0 million within 10 days of the settlement's effective date¹. Following that payment, the parties will terminate with prejudice all ongoing patent litigation over the two patents named in the suit¹.

The settlement also sets terms for future claims. REGENXBIO and UPenn are releasing all current infringement claims and agreeing not to sue over future claims tied to any Sarepta gene therapy that relies on an AAVrh74-based capsid, which covers ELEVIDYS, in relation to the two patents at issue, a related patent (U.S. Patent No. 9,198,984), and other related patents and applications.¹ In return, REGENXBIO agreed not to pursue Sarepta or its affiliates, licensees, or commercial partners over its own patents or patent applications covering the current version of ELEVIDYS or the AAVrh74 capsid sequence, though this carve-out does not reach other gene therapy patents REGENXBIO holds¹.

REGENXBIO said it plans to attach the full settlement agreement to its quarterly report for the period ending September 30, 2026¹, which will provide the complete contract terms beyond this summary.