Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 102

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 102
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 or adequate efficacy and
safety to obtain marketing approval to market its product candidates.

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Further, the FDA and comparable foreign regulatory
authorities have substantial discretion in the approval process and in determining when or whether marketing approval will be obtained
for any of Tvardi’s product candidates. Tvardi’s product candidates may not be approved even if they achieve their primary
endpoints in future Phase 3 clinical trials or registrational trials. The FDA or comparable foreign regulatory authorities may disagree
with Tvardi’s clinical trial designs and its interpretation of data from preclinical studies or clinical trials. Further, requirements
regarding clinical trial data may evolve. Changes to data requirements may cause the FDA or comparable foreign regulatory authorities
to disagree with data from preclinical studies or clinical trials and may require further studies.

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In addition, any of these regulatory authorities
may change requirements for the approval of a product candidate even after reviewing and providing comments or advice on a protocol for
a pivotal Phase 3 or registrational clinical trial. In addition, any of these regulatory authorities may also approve a product candidate
for fewer or more limited indications than Tvardi requests or may grant approval contingent on the performance of costly post-marketing
clinical trials. The FDA or comparable foreign regulatory authorities may not approve the labeling claims that Tvardi believes would be
necessary or desirable for the successful commercialization of its product candidates, if approved.

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Tvardi may not be successful in its efforts to identify or discover additional product candidates in the future.

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Tvardi’s research programs may initially show
promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for a number of reasons,
including:

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| ● | Tvardi’s inability to design such product candidates with the pharmacological properties that it desires or attractive PK; or |

| ● | potential product candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be medicines that will receive marketing approval and achieve market acceptance. |

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Research programs to identify new product candidates
require substantial technical, financial, and human resources. If Tvardi is unable to identify suitable compounds for preclinical and
clinical development, it will not be able to obtain product revenue in future periods, which likely would result in significant harm to
its financial position and adversely impact its stock price.

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Due to Tvardi’s limited resources and access to capital, it must