Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 112

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 112
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 of the product candidate.

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In addition, if the FDA, the European Medicines
Agency (EMA), or a comparable foreign regulatory authority approves Tvardi’s product candidates, the manufacturing processes, labeling,
packaging, distribution, post-

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approval monitoring and AE reporting, storage, import, export, advertising,
promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. The FDA has significant
post-market authority, including the authority to require labeling changes based on new safety information and to require post-market
studies or clinical trials to evaluate safety risks related to the use of a product or to require withdrawal of the product from the market.
The FDA also has the authority to require a REMS plan after approval, which may impose further requirements or restrictions on the distribution
or use of an approved drug. The manufacturing facilities Tvardi uses to make a future product, if any, will also be subject to periodic
review and inspection by the FDA and other regulatory agencies, including for continued compliance with cGMPs requirements. The discovery
of any new or previously unknown problems with Tvardi’s third-party manufacturers, manufacturing processes or facilities may result
in restrictions on the product, manufacturer or facility, including withdrawal of the product from the market. As Tvardi expects to rely
on third-party manufacturers, it will not have control over compliance with applicable rules and regulations by such manufacturers.

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Any product promotion and advertising will also
be subject to regulatory requirements and continuing regulatory review. The FDA strictly regulates marketing, labeling, advertising and
promotion of prescription drugs. These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored
scientific and educational activities, promotional activities involving the internet and off-label promotion. Any regulatory approval
that the FDA grants is limited to those specific diseases and indications for which a product is deemed to be safe and effective by FDA.
Although clinicians may prescribe products for off-label uses as the FDA and other regulatory agencies do not regulate a physician’s
choice of drug treatment made in the physician’s independent medical judgment, Tvardi’s ability to promote any products will
be narrowly limited to those indications that are specifically approved by the FDA. In addition, as Tvardi does not intend to conduct
head-to-head comparative clinical trials for its product candidates, it will be unable to make comparative claims regarding any other
products in the promotional materials for its product candidates.

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If Tvardi promotes its approved products in