Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 106

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 106
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ure compared to conventional FDA procedures or pathways, and receiving a Fast Track designation does not provide assurance
of ultimate FDA licensure. In addition, the FDA may withdraw any Fast Track designation granted to Tvardi if it believes that the designation
is no longer supported by data from Tvardi’s clinical development program. The FDA may also withdraw any Fast Track designation
at any time.

​

Even if a product candidate Tvardi develops receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

​

Even if TTI-101, TTI-109 or any other product candidate
Tvardi develops receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party
payors, such as Medicare and Medicaid programs and managed care organizations, and others in the medical community. In addition, the availability
of coverage by third-party payors may be affected by existing and future healthcare reform measures designed to reduce the cost of health
care. If the product candidates Tvardi develops do not achieve an adequate level of acceptance, Tvardi may not generate significant product
revenues and Tvardi may not become profitable.

​

The degree of market acceptance of any product candidate,
if approved for commercial sale, will depend on a number of factors, including:

​

| ● | efficacy and potential advantages compared to alternative treatments; |

| ● | the ability to offer Tvardi’s products, if approved, for sale at competitive prices; |

| ● | convenience and ease of administration compared to alternative treatments; |

| ● | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |

| ● | the recommendations with respect to Tvardi’s product candidates in guidelines published by various scientific organizations applicable to Tvardi and its product candidates; |

| ● | the strength of marketing and distribution support; |

| ● | the ability to obtain sufficient third-party coverage and adequate reimbursement; and |

| ● | the prevalence and severity of any side effects. |

​

If government and other third-party payors do not
provide coverage and adequate reimbursement levels for any products Tvardi commercializes, market acceptance and commercial success would
be reduced.

​

Tvardi faces substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than Tvardi.

​

The development and commercialization of new drug
products is highly competitive.