Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 423

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 423
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 (difelikefalin) injection/Kapruvia | ​ | ​ | Pruritus CKD – Hemodialysis | ​ | ​ | Approved in the U.S. (08/2021)                                                                
 Approved in EU incl. UK (04/2022)                                                             
 Approved in Japan (09/2023)                                                                   
 Other approvals: Switzerland, Canada, Singapore, Australia, Kuwait, Israel, UAE, Saudi Arabia | ​ | ​ | ​              | ​ | ​ | CSL Vifor (Worldwide excl. Japan and South Korea)* 
 Maruishi (Japan)                                   
 CKDP (South Korea)                                 | ​ |

* Cara is party to two collaborations for the commercialization of KORSUVA (difelikefalin) injection/ Kapruvia with a joint venture between CSL Vifor and Fresenius Medical Care. In this section, unless the context otherwise requires, “CSL Vifor” refers to CSL Vifor and its affiliated entities, including, where applicable, the joint venture. KORSUVA (difelikefalin) injection — Cara’s Commercial Stage Product Overview Cara has out-licensed to CSL Vifor the commercialization of KORSUVA injection/Kapruvia in dialysis patients with moderate-to-severe pruritus associated with chronic kidney disease, or advanced CKD-aP, worldwide, excluding Japan (licensed to Maruishi/sub-licensee Kissei), and South Korea (licensed to CKDP). On August 23, 2021, KORSUVA injection was approved by the FDA for the treatment of moderate-to-severe pruritus associated with advanced CKD in adults undergoing hemodialysis. In December 2021, CMS granted Transition Drug Add-on Payment Adjustment (TDAPA), to KORSUVA injection in the anti-pruritic functional category. TDAPA went into effect on April 1, 2022 for two years. The commercial launch

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of KORSUVA injection commenced in April 2022 and Cara began recording the associated profit-sharing revenues in the second quarter of 2022. On October 27, 2023, CMS published the final CY 2024 rule, which finalized the post-TDAPA add-on payment as proposed in the draft CY 2024 rule. Under the final rule, TDAPA drugs in existing functional categories will receive a post-TDAPA add-on payment set at 65