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ProKidney Halts 1 Phase 3 Trial of Rilparencel, Says Not Essential for Securing FDA Approval
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ProKidney Halts 1 Phase 3 Trial of Rilparencel, Says Not Essential for Securing FDA Approval
Sep 3, 2024 6:49 AM

09:20 AM EDT, 09/03/2024 (MT Newswires) -- ProKidney ( PROK ) said Tuesday it will discontinue its PROACT 2 phase 3 trial of rilparencel that focused on enrollment outside the US, believing it is not required for initial US registration.

The company said rilparencel, a potential treatment for the preservation of kidney function in type 2 diabetes and advanced chronic kidney disease patients, is eligible for the US Food and Drug Administration's initial approval under an expedited approval path based on successful completion of the ongoing PROACT 1 phase 3 trial.

ProKidney ( PROK ) said that with PROACT 2 discontinued, it now expects current cash to support operating plans into Q1 of 2027.

The company said the updated phase 3 program for rilparencel helps it focus its resources on PROACT 1 to expedite enrollment, accelerate estimated topline data results to Q3 of 2027, and cut expenses by about $150 million to $175 million.

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