ProKidney, LLC

537 million people globally live with diabetes, with 50% undiagnosed and 75% in low-income or middle-income nations. Cell and gene therapies are emerging as new frontiers for diabetes management. ProKidney focuses on US trial for T2D and CKD cell therapy rilparencel, discontinuing a Spanish trial. Amarna Therapeutics secures FDA guidance for diabetes gene therapy AM510. Vertex's VX-880 cell therapy shows potential to eliminate insulin use in T1D. First patient screened for SkinTE phase 3 trial for diabetic foot ulcers.

ProKidney focuses on REGEN-006 trial, Oncternal discontinues ONCT-808-101, Vironexis receives FDA clearance for VNX-101, BridgeBio halts BBP-631, HAYA and BridgeBio collaborate on RNA therapeutics, eGenesis raises funds for EGEN-2784, Neurocrine licenses capsid from Voyager, Atsena's ATSN-201 gets orphan drug designation.

ProKidney is focusing on its phase 3 REGEN-006 (PROACT 1) trial for rilparencel in US patients with T2D and CKD, discontinuing PROACT 2 in Spain. The company anticipates expedited US approval via RMAT designation, with topline findings expected in Q3 2027. PROACT 1, modified to focus on stage 4 CKD and late stage 3b CKD with albuminuria, aims to accelerate US registration and commercial launch. Positive interim REGEN-007 data supports rilparencel's potential to preserve kidney function.

ProKidney is discontinuing its ex-US Phase III study for CKD cell therapy rilparencel to focus on the US market, saving $150m-$175m. The decision follows regulatory discussions and aims to expedite market entry in the US, where the therapy has RMAT designation.