Optimized PROACT 1 Design, Preserved Statistical Power, and Clear Regulatory Path Support Buy Rating on ProKidney

Analyst Joseph Pantginis of H.C. Wainwright maintained a Buy rating on ProKidney, retaining the price target of $12.00.

Joseph Pantginis has given his Buy rating due to a combination of factors tied to the progress and design of the PROACT 1 trial of rilparencel in chronic kidney disease with type 2 diabetes. He views the decision to lower the target enrollment to roughly 470 patients as a positive optimization that maintains robust statistical power—around 80% by relying on current and projected follow-up, and potentially near 90% with continued enrollment into mid-2026—while reducing cost and execution risk. He also highlights that the overall trial timelines remain intact, with enrollment completion and key surrogate endpoint data (eGFR slope) expected in 2Q27 to support a potential accelerated BLA submission in the second half of 2027, and final time‑to‑event outcome data anticipated in 2H29.

Pantginis underscores that the pivotal design is closely aligned with encouraging Phase 2 results, which he believes increases the likelihood of a favorable readout on both surrogate and confirmatory endpoints. He is further encouraged by unusually strong patient participation for a cell therapy study, with approximately 470 patients expected in the confirmatory dataset, which should enhance the robustness of the efficacy and safety assessment. Importantly, he emphasizes that the trial’s statistical powering assumptions for both the accelerated and full‑approval endpoints are unchanged despite the lower enrollment target, supporting confidence in the integrity of the program. Overall, Pantginis concludes that the combination of strong enrollment momentum, preserved statistical power, and a clear regulatory path underpins his positive view of rilparencel’s first‑in‑class regenerative potential and supports his Buy rating on ProKidney.