ProKidney Corp., a clinical-stage biotech company at the forefront of regenerative medicine, has announced strategic updates to its Phase 3 program for rilparencel, a pioneering cell therapy aimed at treating type 2 diabetes and advanced chronic kidney disease (CKD). After extensive consultation with regulatory experts, ProKidney has chosen to focus on the ongoing Phase 3 REGEN-006 (PROACT 1) trial, believing it will allow for expedited FDA approval under the RMAT designation.
This decision not only accelerates the timeline for bringing rilparencel to the U.S. market, addressing a critical need, but also aligns with the goals of the NSF Engine’s regenerative medicine initiative. By streamlining its approach, ProKidney is reducing costs, extending its financial runway, and reinforcing the regenerative medicine ecosystem that NSF Engine is fostering—ultimately contributing to the commercialization and accessibility of groundbreaking therapies.
Read more at prokidney.com.