Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 111

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 111
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 de-prioritization
of preclinical studies or clinical trials or delay in regulatory review resulting from such disruptions could adversely affect the development
and clinical testing of TTI-101, TTI-109 or other current or future product candidates.

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Further, the FDA and its foreign counterparts may
respond to any NDA that Tvardi may file by defining requirements that Tvardi does not anticipate. Such responses could delay clinical
development of TTI-101, TTI-109 or any other current or future product candidates.

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Any delay or failure in obtaining required approvals
could adversely affect Tvardi’s ability to generate revenue from the particular product candidate for which Tvardi is seeking approval.
Furthermore, any regulatory approval to market a product may be subject to limitations on the approved uses for which Tvardi may market
the product or on the labeling or other restrictions.

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Tvardi is also subject to or may in the future become
subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing
authorization, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries and may include all
of the risks associated with the FDA approval process described above, as well as risks attributable to the satisfaction of local regulations
in foreign jurisdictions. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval. FDA approval
does not ensure approval by regulatory authorities outside the United States and vice versa. Any delay or failure to obtain U.S. or foreign
regulatory approval for a product candidate could have a material and adverse effect on Tvardi’s business, financial condition,
results of operations and prospects.

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Even if Tvardi receives regulatory approval for its product candidates, it will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, Tvardi’s product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Tvardi may be subject to penalties if it fails to comply with regulatory requirements or experience unanticipated problems with its product candidates.

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Any regulatory approvals that Tvardi or its future
collaborators obtain for its product candidates may also be subject to limitations on the approved indicated uses for which a product
may be marketed or to the conditions of approval or contain requirements for potentially costly post-marketing testing and surveillance
to monitor the safety and efficacy