Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 428

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 428
---
 sales reported by CSL Vifor for the second quarter of 2024 primarily due to higher rebates and

<div align='center'>247</div>

TABLE OF CONTENTS

chargebacks due to price decreases on KORSUVA injection related to the expiration of TDAPA in April 2024. For the nine months ended September 30, 2023, CSL Vifor recorded net sales of KORSUVA injection in the United States of approximately $21.5 million.

•

Shipments of KORSUVA injection vials from wholesalers in the United States to the dialysis clinics. 56,976 and 90,828 KORSUVA injection vials were shipped from wholesalers to the dialysis clinics for the three months ended September 30, 2024 and 2023, respectively, and 245,568 and 203,400 KORSUVA injection vials were shipped from wholesalers to the dialysis clinics for the nine months ended September 30, 2024 and 2023, respectively. Of the vials shipped to the FMC dialysis centers for the three and nine months ended September 30, 2024, a portion was reallocated product by FMC within its network of clinics.

#### Difelikefalin Development in Pruritus
Difelikefalin, Cara’s selective, predominantly peripherally acting, non-scheduled Kappa opioid receptor agonist, acts on the peripheral neurons responsible for sensing pruritus. Given this unique mechanism of action, difelikefalin is thought to work broadly independent of the origin of itch. To date, Cara has studied difelikefalin for pruritus associated with systemic, inflammatory, and neuropathic diseases. The IV formulation is approved in the United States, EU and other countries around the world for the treatment of advanced CKD-aP in adults undergoing hemodialysis. Cara studied the oral formulation at multiple dosage strengths in moderate-to-severe pruritus associated with NP with positive efficacy signals across all completed mono therapy studies. In Cara’s NP program, oral difelikefalin was generally well tolerated with all adverse events in difelikefalin-treated patients reported as mild or moderate in severity.

On June 12, 2024, Cara announced its decision to discontinue the clinical program in NP following the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-se