ProKidney Corp. (PROK) Tuesday announced strategic updates to its Phase 3 program for rilparencel, the company's drug candidate to preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease (CKD).
After conducting a comprehensive review, the company concluded that rilparencel is eligible for initial FDA approval under the provisions of the Regenerative Medicine Advanced Therapy (RMAT) designation after successfully completing the ongoing Phase 3 REGEN-006 (PROACT 1) study.
Following this, the company intends to discontinue ex-U.S. based Phase 3 REGEN-016 (PROACT 2) study as this is not required for initial U.S. registration.
Topline data from the PROACT 1 study is expected by the third quarter of 2027.
Additionally, ProKidney now expects current cash to support operating plans into the first quarter of 2027.
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