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.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.