Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 116

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 116
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 financial condition.

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Changes to current healthcare laws and state and
federal healthcare reform measures that may be adopted in the future that impact coverage and reimbursement for drug or biologic products
may result in additional payment reductions in Medicare and other healthcare funding and otherwise affect the prices Tvardi may obtain
for any product candidates for which it may obtain regulatory approval or the frequency with which any such product candidate is prescribed
or used.

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Recently enacted legislation, future legislation and other healthcare reform measures may increase the difficulty and cost for Tvardi to obtain marketing approval for and commercialize product candidates and may affect the prices Tvardi may set.

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In the United States and some foreign jurisdictions,
there have been, and Tvardi expects there will continue to be, a number of legislative and regulatory changes to the healthcare system,
including cost-containment measures that may reduce or limit coverage and reimbursement for newly approved drugs and affect Tvardi’s
ability to profitably sell any product candidates for which it obtains marketing approval. In particular, there have been and continue
to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare.

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For example, in March 2010, the Patient Protection
and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the ACA), was enacted in the United
States, which resulted in delays in the implementation of, and action taken to repeal or replace, certain aspects of the ACA. On June
17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because
the “individual mandate” was repealed by Congress. In addition, there have been a number of health reform initiatives by the
Biden administration that have impacted the ACA. For example, on August 16, 2022, President Biden signed the Inflation Reduction Act of
2022 (IRA), into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA
marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning
in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program.
It is possible that the ACA will be subject to judicial or congressional challenges in the future. Additionally, on July 4, 2025, the
annual reconciliation bill, the One Big Beautiful