Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 104

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 104
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. Additionally,
the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many
foreign regulatory authorities have similar approval requirements. In addition, such foreign clinical trials would be subject to the applicable
local laws of the foreign jurisdictions where the clinical trials are conducted. There can be no assurance that the FDA or any comparable
foreign regulatory authority will accept data from clinical trials conducted outside of the United States or the applicable jurisdiction.
If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional clinical
trials, which could be costly and time-consuming, and which may result in current or future product candidates that Tvardi may develop
not receiving approval for commercialization in the applicable jurisdiction.

​

Although Tvardi has received U.S. orphan drug designation for TTI-101 for IPF and HCC, it may be unable to obtain and maintain orphan drug designation for other product candidates and, even if Tvardi obtains such designation, it may not be able to realize the benefits of such designation, including potential marketing exclusivity of its product candidates, if approved.

​

Regulatory authorities in some jurisdictions, including
the United States and other major markets, may designate drugs intended to treat conditions or diseases affecting relatively small patient
populations as orphan drugs. Under the Orphan Drug Act of 1983, the FDA, may designate a product candidate as an orphan drug if it is
intended to treat a rare disease or condition, which is generally defined as having a patient population of fewer than 200,000 individuals
in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that
the cost of developing the drug will be recovered from sales in the United States. Although Tvardi has received U.S. orphan drug designation
for TTI-101 for IPF and HCC, the designation of any of its product candidates as an orphan drug does not mean that any regulatory agency
will accelerate regulatory review of, or ultimately approve, that product candidate, nor does it limit the ability of any regulatory agency
to grant orphan drug designation to product candidates of other companies that treat the same indications as Tvardi’s product candidates.

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Generally, if a product candidate with an orphan
drug designation receives the first marketing approval for the indication for which it has such designation, the product is entitled to
a period of marketing exclusivity, which precludes the FDA or foreign