Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 114

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 114
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 FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review submissions
or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.

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Coverage and reimbursement may be limited or unavailable or pricing unfavorable in certain market segments for Tvardi’s product candidates, if approved, which could make it difficult for Tvardi to sell any product candidates profitably.

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Significant uncertainty exists as to the coverage
and reimbursement status of any products for which Tvardi may obtain regulatory approval. In the United States, sales of any products
for which Tvardi may receive regulatory marketing approval will depend, in part, on the availability of coverage and adequacy of reimbursement
from third-party payors. Third-party payors include government authorities such as Medicare, Medicaid, TRICARE and the Veterans Administration,
managed care providers, private health insurers, and other organizations. Patients who are provided medical treatment for their conditions
generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Coverage and adequate reimbursement
from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. Patients
are unlikely to use Tvardi’s product candidates unless coverage is provided, and reimbursement is adequate to cover a significant
portion of the cost. Tvardi cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential
revenue from, its product candidates or assure that coverage and adequate reimbursement will be available for any product that Tvardi
may develop and, if reimbursement is available, what the level of reimbursement will be.

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Government authorities and other third-party payors
decide which drugs and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third-party payor may
depend upon a number of factors, including the third-party payor’s determination that use of a product is:

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| ● | a covered benefit under its health plan; |

| ● | safe, effective and medically necessary; |

| ● | appropriate for the specific patient; |

| ● | cost-effective; and |

| ● | neither experimental nor investigational. |

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In the United States, as well as foreign jurisdictions,
no uniform policy of coverage and reimbursement for products exists among third-party payors.

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Coverage and reimbursement for products may vary
depending on the payor, the insurance plan and other factors. As a result, obtaining coverage and reimbursement approval of a product