Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 117

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 117
---
 Bill Act (OBBBA), was signed into law which is expected to reduce Medicaid spending
and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and
limiting provider taxes used to fund the program. OBBBA also narrows access to ACA marketplace exchange enrollment and declines to extend
the ACA enhanced advanced premium tax credits, set to expire in 2025, which, among other provisions in the law, are anticipated to reduce
the number of Americans with health insurance. Moreover, the American Taxpayer Relief Act of 2021, effective January 1, 2024, eliminated
the

<div align='center'>70</div>

Table of Contents

statutory cap on rebate amounts owed by drug manufacturers under the
MDRP, previously capped at 100% of the Average Manufacturer Price for a covered outpatient drug.

​

Further, there has been heightened governmental
scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs. Such scrutiny has
resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things,
bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government
program reimbursement methodologies for products. For example, the IRA, among other things, (1) directs the Department of Health &
Human Services (HHS), to negotiate the price of certain single-source drugs and biologics covered under Medicare and (2) imposes rebates
under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions began to take effect progressively
starting in fiscal year 2023. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation for
the initial years. HHS has and will continue to issue and update guidance as these programs are implemented. On August 15, 2024, HHS announced
the agreed-upon reimbursement prices of the first ten drugs that were subject to price negotiations, although the Medicare drug price
negotiation program is currently subject to legal challenges. On January 17, 2025, HHS selected 15 additional products covered under Part
D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation
Program. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework
for