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REGENXBIO settles Sarepta patent dispute for $39M

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

On September 23, 2026, REGENXBIO Inc. entered into a settlement agreement with The Trustees of the University of Pennsylvania, Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., concerning patent litigation related to Sarepta’s SRP-9001, also known as ELEVIDYS in the U.S. Sarepta will pay REGENXBIO $39.0 million within 10 days of the agreement’s effective date. Thereafter, the parties will terminate with prejudice all ongoing patent litigation regarding the patents in suit.

REGENXBIO and UPenn agreed to release current claims and not pursue specified future claims relating to Sarepta gene therapy products using an AAVrh74-based capsid, including ELEVIDYS. REGENXBIO also agreed not to sue over its patents covering ELEVIDYS in its existing form or the capsid sequence; that commitment does not extend to patents covering other aspects of gene therapy products.

Positive

  • None.

Negative

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Filing Explained

The 8-K says its description of the agreement is incomplete; REGENXBIO intends to file the full settlement agreement with its Form 10-Q for the quarter ending September 30, 2026, so this filing does not provide the complete contract terms.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Settlement payment $39.0 million Sarepta payment to REGENXBIO under the Settlement Agreement
Payment timing 10 days Within 10 days of the Settlement Agreement’s effective date
terminate with prejudice regulatory
"terminate with prejudice all ongoing patent litigation"
covenant not to sue regulatory
"a covenant not to sue for future claims"
A covenant not to sue is a legal agreement in which one party promises not to bring a lawsuit against another party over specified claims or actions. It matters to investors because such covenants can limit future legal exposure, settle disputes without admitting liability, and affect a company’s risk profile and potential costs—similar to signing a truce that removes a particular legal threat but does not necessarily resolve all underlying issues.
AAVrh74-based capsid technical
"gene therapy product that uses an AAVrh74-based capsid"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much will Sarepta pay REGENXBIO (RGNX) under the settlement?

Sarepta will pay REGENXBIO $39.0 million within 10 days of the Settlement Agreement’s effective date.

Which patents does the RGNX settlement address?

The settlement addresses U.S. Patent Nos. 10,526,617 and 11,680,274. The future-claims covenant also references U.S. Patent No. 9,198,984 and related patents and patent applications.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Learn about SEC filing dates
false000159087700015908772026-09-232026-09-23

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 23, 2026

 

 

REGENXBIO Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-37553

47-1851754

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

9804 Medical Center Drive

 

Rockville, Maryland

 

20850

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (240) 552-8181

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

RGNX

 

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 1.01. Entry into a Material Definitive Agreement.

On September 23, 2026, REGENXBIO Inc. (the “Company”) and The Trustees of the University of Pennsylvania (“UPenn”) entered into a Settlement Agreement (the “Settlement Agreement”) with Sarepta Therapeutics, Inc. and Sarepta Therapeutics Three, LLC (together with Sarepta Therapeutics, Inc., “Sarepta”) and Catalent, Inc. to resolve all patent infringement litigation alleging infringement of U.S. Patent No. 10,526,617 (the “617 patent”) and U.S. Patent No. 11,680,274 (the ”274 patent”) (together with the 617 patent, “the Patents-in-Suit”) related to Sarepta's manufacture, use, offer to sell and sale of SRP-9001 (also known as ELEVIDYS® in the U.S.).

Pursuant to the terms of the Settlement Agreement, Sarepta will make a payment of $39.0 million to the Company within 10 days of the effective date of the Settlement Agreement. Thereafter, the parties will terminate with prejudice all ongoing patent litigation regarding the Patents-in-Suit. The Settlement Agreement includes the release by the Company and UPenn of all current claims of infringement and a covenant not to sue for future claims relating to any Sarepta gene therapy product that uses an AAVrh74-based capsid, including ELEVIDYS, relating to the Patents-in-Suit, U.S. Patent No. 9,198,984, and related patents and patent applications. In addition, the Company agreed not to sue Sarepta or its affiliates, licensees or commercial partners over any Company patents or patent applications that cover the existing form of ELEVIDYS or the AAVrh74-based capsid sequence; but does not extend to patents or patent applications that cover other aspects of gene therapy products.

The foregoing description of the terms of the Settlement Agreement does not purport to be complete and is qualified in its entirety by the full text of such agreement. The Company intends to file a copy of the Settlement Agreement with its Quarterly Report on Form 10-Q for the quarter ending September 30, 2026.

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

REGENXBIO INC.

 

 

 

 

Date:

September 23, 2026

By:

/s/ Patrick J. Christmas II

 

 

 

Patrick J. Christmas II
Executive Vice President, Chief Strategy & Legal Officer

 


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