Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 118

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 118
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 Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use
when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue
under the new framework.

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The current Trump administration is pursuing policies
to reduce regulations and expenditures across government including at HHS, the FDA, the Centers for Medicare & Medicaid Services (CMS)
and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may
propose policy changes that create additional uncertainty for our business. These actions, for example, include (1) directives to reduce
agency workforce; (2) rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation (CMMI)
to consider new payment and healthcare models to limit drug spending; (3) eliminating the Biden administration’s executive order
that directed HHS in establishing an AI task force and developing a strategic plan; (4) directing HHS and other agencies to lower prescription
drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing
Most-Favored-Nation pricing for pharmaceutical products; (5) imposing tariffs on imported pharmaceutical products; (6) directing certain
federal agencies to enforce existing law regarding hospital and plan price transparency and by standardizing prices across hospitals and
health plans; and (7) as part of the Make America Healthy Again (MAHA) Commission’s recent Strategy Report, working across government
agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, in its June 2024 decision in Loper Bright
Enterprises v. Raimondo (Loper Bright), the U.S. Supreme Court overturned the longstanding Chevron doctrine, under which courts were required
to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper Bright decision could
result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including
those issued by the FDA. Congress may introduce and ultimately pass health care related legislation that could, among others, impact the
drug approval process, modify the Medicare Drug Price Negotiation Program, expand the orphan drug exclusion in the IRA, and reduce Medicaid
enrollment and funding. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction
in payments from private payors. The implementation of current and future cost containment measures or other