Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 120

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 120
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regulations. These decisions could introduce additional uncertainty into the regulatory process and may result in additional legal challenges
to actions taken by federal regulatory agencies, including the FDA and the Centers for Medicare & Medicaid Services that Tvardi relies
on. In addition to potential changes to regulations as a result of legal challenges, these decisions may result in increased regulatory
uncertainty and delays and other impacts, any of which could adversely impact Tvardi’s business and operations.

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At the state level, legislatures have increasingly
passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement
constraints. Tvardi expects that the ACA, the IRA, and any other healthcare reform measures that may be adopted in the future may result
in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional
downward pressure on the price that Tvardi receives for any approved product. Any reduction in reimbursement from Medicare or other government
programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare
reforms may prevent Tvardi from being able to generate revenue, attain profitability or commercialize its product candidates, if approved.

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Tvardi’s operations and relationships with healthcare providers, healthcare organizations, customers and third-party payors will be subject to applicable anti-bribery, anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose Tvardi to, among other things, enforcement actions, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

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Tvardi’s future arrangements with healthcare
providers, healthcare organizations, third-party payors and customers will expose Tvardi to broadly applicable anti-bribery, fraud and
abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which
Tvardi researches, markets, sells and distributes its products, if approved. Restrictions under applicable federal and state anti-bribery
and healthcare laws and regulations, include the following:

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| ● | the federal Anti-Kickback Statute, which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for