Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 119

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 119
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 healthcare reforms may adversely
affect Tvardi’s operations and prevent it from being able to generate revenue, attain profitability, or commercialize Tvardi’s
product candidates.

​

Tvardi’s ability to develop and market new
drug products may be impacted if litigation challenging the FDA’s approval of another company’s drug continues. In April 2023,
the U.S. District Court for the Northern District of Texas invalidated the approval by the FDA of mifepristone, a drug product, which
was originally approved in 2000, and whose distribution is governed by various measures adopted under a REMS. The Court of Appeals for
the Fifth Circuit declined to order the removal of mifepristone from the market but did hold that plaintiffs were

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likely to prevail in their claim that changes allowing for expanded
access of mifepristone, which the FDA authorized in 2016 and 2021, were arbitrary and capricious. In June 2024, the Supreme Court reversed
and remanded that decision after unanimously finding that the plaintiffs did not have standing to bring this legal action against the
FDA. Depending on the outcome of this litigation, if it continues, Tvardi’s ability to develop TTI-101, TTI-109 or future product
candidates Tvardi may develop may be at risk and could be delayed, undermined or subject to protracted litigation. Finally, Tvardi could
be adversely affected by several significant administrative law cases decided by the U.S. Supreme Court in 2024. In Loper Bright Enterprises v. Raimondo, for example, the court overruled Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which for 40
years required federal courts to defer to permissible agency interpretations of statutes that are silent or ambiguous on a particular
topic. The Supreme Court stripped federal agencies of this presumptive deference and held that courts must exercise their independent
judgment when deciding whether an agency such as FDA acted within its statutory authority under the Administrative Procedure Act (the
APA). Additionally, in Corner Post, Inc. v. Board of Governors of the Federal Reserve System, the court held that actions to challenge
a federal regulation under the APA can be initiated within six years of the date of injury to the plaintiff, rather than the date the
rule is finalized. The decision appears to give prospective plaintiffs a personal statute of limitations to challenge longstanding agency