Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 140

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 140
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and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with Tvardi’s assessment
of whether such extensions are available, and may refuse to grant extensions to its patents, or may grant more limited extensions than
Tvardi requests. If this occurs, Tvardi’s competitors may be able to obtain approval of competing products following the patent
expiration by referencing Tvardi’s clinical and preclinical data and launch their product earlier than might otherwise be the case.
If this were to occur, it could have a material adverse effect on Tvardi’s ability to generate revenue.

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In the context of the European Union, the Court
of Justice of the European Union has recently restricted grant of supplementary protection certificate (SPC), for new medical uses of
existing products, thus narrowing the availability of patent term extension for second medical uses. Therefore, any development of Tvardi’s
product candidates with respect to second medical uses may be adversely affected in the European Union. In addition, within the European
Union, regulatory protections afforded to medicinal products such as data exclusivity, marketing protection, market exclusivity for orphan
indications and pediatric extensions are currently under review and may likely be curtailed in future years. On April 26, 2023, the European
Commission adopted a proposal for a new Regulation set to replace Regulation (EC) No 726/​2004 and a new Directive replacing Directive
2001/83 on

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the Community Code relating to medicinal products for human use. If
made into law, this proposal will revise and replace the existing general pharmaceutical legislation and will affect the existing period
of regulatory protection afforded to medicinal products in the European Union and Northern Ireland. If Tvardi is unable to obtain patent
term extension or the term of any such extension is less than it requests, or if data exclusivity or other regulatory protections are
reduced, Tvardi’s competitors may obtain approval of competing products following Tvardi’s patent expiration, and its business,
financial condition, results of operations and prospects could be materially harmed.

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Changes in the interpretation of patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing Tvardi’s ability to protect its products.

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The United States Congress is responsible for passing
laws establishing patentability standards. As with any laws, implementation is left to federal agencies and the federal courts based