Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 105

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 105
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 regulatory authorities from approving another marketing application
for a product that constitutes a similar medicinal product treating the same indication for that marketing exclusivity period, except
in limited circumstances. The applicable period is seven years in the United States. Orphan drug exclusivity may be revoked if any regulatory
agency determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity
of the product to meet the needs of patients with the rare disease or condition.

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Although Tvardi received orphan drug designation
for TTI-101 for IPF and HCC, that exclusivity may not effectively protect the product candidate from competition because different drugs
with different active moieties can be approved for the same condition in the United States. Even after an orphan drug is approved, the
FDA may subsequently approve another drug with the same active moiety for the same condition if the FDA concludes that the latter drug
is not a similar medicinal product or is clinically superior in that it is shown to be safer, more effective or makes a major contribution
to patient care. Any legislative changes to the orphan drug provisions could change Tvardi’s opportunities for, or likelihood of
success in obtaining, orphan drug exclusivity and would materially adversely affect Tvardi’s business, results of operations, financial
condition and prospects.

​

Although Tvardi has received a Fast Track designation from the FDA for TTI-101 for HCC, it may not benefit from a faster development or regulatory review or approval process, and a Fast Track designation does not increase the likelihood that its product candidates will receive marketing approval.

​

If a drug product is intended for the treatment
of a serious or life-threatening disease or condition and it demonstrates the potential to address unmet medical needs for such a disease
or condition, the drug sponsor may apply for FDA Fast Track designation for a particular indication. Tvardi has received Fast Track designation
for TTI-101 for the treatment of relapsed/refractory locally advanced, unresectable or metastatic HCC but may never receive Fast Track
designation for its pipeline programs. Marketing applications submitted by sponsors of products

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in Fast Track development may qualify for priority review under the
policies and procedures offered by the FDA, but the Fast Track designation does not assure any such qualification or ultimate marketing
licensure by the FDA. Although Tvardi received Fast Track designation for TTI-101, it may not experience a faster development process,
review or licens