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Madrigal (NASDAQ: MDGL) gains control of Rezdiffra patent extensions

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Madrigal Pharmaceuticals amended its long-standing collaboration with Roche covering Rezdiffra. Effective January 29, 2026, Madrigal gains full and exclusive control over all patent term adjustments and patent term extensions applicable to Rezdiffra, including patents owned by Roche and those jointly owned.

In exchange for this expanded control of Rezdiffra’s patent life, the royalty that Madrigal pays Roche on net sales of Rezdiffra will not be reduced until certain patent term extensions that have been, or could have been, filed have expired. The amendment is documented in a First Amendment agreement filed as an exhibit.

Positive

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Negative

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Insights

Madrigal gains control of Rezdiffra patent extensions while keeping Roche royalties unchanged for longer.

The amendment gives Madrigal exclusive discretion over patent term adjustments and patent term extensions for Rezdiffra, even on patents owned or co-owned with Roche. This concentrates decision-making about Rezdiffra’s patent life within Madrigal, which can simplify long-term protection strategy.

In return, the royalty Roche earns on net sales of Rezdiffra will not be reduced until certain patent term extensions have expired or would have been expected to expire. That means Roche’s economic participation per unit of sales is preserved for a longer period than before this amendment.

The overall economic impact for Madrigal depends on Rezdiffra sales levels and the duration of the relevant patent term extensions described in the amendment. Future company disclosures may provide more detail on how this structure affects Rezdiffra’s long-term revenue profile.

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.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
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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): January 29, 2026

 

 

 

MADRIGAL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-33277   04-3508648

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

Four Tower Bridge

200 Barr Harbor Drive, Suite 200

West Conshohocken, Pennsylvania

  19428
(Address of principal executive offices)   (Zip Code)

 

(267) 824-2827

Registrant’s telephone number, including area code 

 

(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, $0.0001 Par Value Per Share   MDGL   The NASDAQ Stock Market LLC

 

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  1.01Entry into a Material Definitive Agreement.

 

On January 29, 2026 (the “Effective Date”), Madrigal Pharmaceuticals, Inc. (the “Company”), F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (together, “Roche”) entered into the First Amendment (the “Amendment”) to the Research, Development, and Commercialization Agreement dated as of December 18, 2008 between the Company and Roche. Pursuant to the terms of the Amendment, effective as of the Effective Date, the Company will have the full and exclusive right and discretion to control all patent term adjustments and patent term extensions applicable to Rezdiffra, including patents owned by Roche and jointly owned between the parties. In consideration of the foregoing, the royalty payable to Roche based on net sales of Rezdiffra will not be reduced until the expiration of certain patent term extensions that have been, or could have been, filed. The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which is filed with this Current Report on Form 8-K as Exhibit 10.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number   Description
   
10.1*   First Amendment to the Research, Development, and Commercialization Agreement, dated as of January 29, 2026, by and between the Company and Roche.
   
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).
     

 

* Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K

 

2

 

 

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.

 

  MADRIGAL PHARMACEUTICALS, INC.
     
  By: /s/ Mardi Dier
    Name: Mardi Dier
    Title: Executive Vice President and Chief Financial Officer
     
Date: January 30, 2026    

 

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FAQ

What change did Madrigal Pharmaceuticals (MDGL) make to its Roche agreement?

Madrigal and Roche signed a First Amendment giving Madrigal full and exclusive control over patent term adjustments and patent term extensions for Rezdiffra. In return, Roche’s royalty rate on Rezdiffra net sales will not be reduced until specified patent term extensions have expired.

How does the amended Roche agreement affect Rezdiffra patents for MDGL?

The amendment grants Madrigal exclusive discretion to control all patent term adjustments and patent term extensions for Rezdiffra, including patents owned by Roche and those jointly owned. This centralizes key patent life decisions at Madrigal for the Rezdiffra franchise.

What happens to Roche’s royalties on Rezdiffra under the new amendment?

Under the amendment, the royalty payable to Roche based on net sales of Rezdiffra will not be reduced until certain patent term extensions that have been, or could have been, filed have expired. This preserves Roche’s royalty economics during that extension period.

When did Madrigal’s amended agreement with Roche on Rezdiffra become effective?

The First Amendment to the Research, Development, and Commercialization Agreement between Madrigal and Roche became effective on January 29, 2026. That effective date governs when Madrigal’s expanded control over Rezdiffra patent term adjustments and extensions, and the revised royalty treatment, take effect.

Which Rezdiffra patents are covered by Madrigal’s new control rights with Roche?

Madrigal’s new rights apply to all patent term adjustments and patent term extensions applicable to Rezdiffra, including patents owned by Roche and those jointly owned by Madrigal and Roche. The specifics are detailed in the First Amendment filed as Exhibit 10.1.

Where can investors see the full text of Madrigal’s Rezdiffra amendment with Roche?

The full text is contained in the First Amendment to the Research, Development, and Commercialization Agreement, dated January 29, 2026, between Madrigal and Roche. It is filed as Exhibit 10.1, with certain portions omitted under Regulation S‑K Item 601(b)(10)(iv).