ProKidney Stock Price, News & Analysis

ProKidney (Nasdaq: PROK) presented full Phase 2 REGEN-007 results at ASN Kidney Week 2025 showing rilparencel slowed CKD progression in patients with advanced CKD and type 2 diabetes. Group 1 (n=24) bilateral kidney injections improved annual eGFR slope by 4.6 mL/min/1.73m2 (78%) versus pre-injection (p<0.001). A subgroup meeting Phase 3 criteria (15/24) improved by 5.5 mL/min/1.73m2 (85%) (p=0.005). Group 2 (n=25) showed a 1.7 mL/min/1.73m2 (50%) improvement that was not statistically significant (p=0.085).

No rilparencel-related serious adverse events were observed and safety was consistent with prior reports. FDA previously accepted eGFR slope as a surrogate endpoint; >50% of ~360 patients for accelerated-approval analysis were enrolled as of Aug 2025, with topline results anticipated in Q2 2027.

ProKidney (Nasdaq: PROK) said senior management will participate in two healthcare conferences in November 2025: a fireside chat at the Guggenheim Healthcare Innovation Conference in Boston on Wednesday, November 12, 2025 at 10:00 AM ET, and one‑on‑one meetings at the Jefferies Global Healthcare Conference in London on November 17–20, 2025.

The Guggenheim fireside chat will be webcast live and the replay will be available in the Events section of ProKidney’s Investor Relations website at www.prokidney.com. Investors seeking one‑on‑one meetings at Jefferies should contact their banking representatives.

ProKidney (Nasdaq: PROK) will present two posters at the American Society of Nephrology Kidney Week 2025 in Houston, Nov 6–9, 2025. One is a late‑breaking poster reporting Phase 2 REGEN‑007 study results: "Renal Autologous Cell Therapy in Diabetes and CKD" (Session: Late‑Breaking Science Posters, Nov 6, 10:00 AM–12:00 PM CST, Board #TH‑PO1203). The second poster covers the inflammatory profile of the cell therapy candidate rilparencel (Session: Development, Stem Cells, and Regenerative Medicine, Nov 6, 10:00 AM–12:00 PM CST, Board #TH‑PO0575).

Copies of both posters will be available on the company website after the event and abstracts are listed on the ASN Kidney Week program site.

ProKidney (Nasdaq: PROK), a late clinical-stage cellular therapeutics company specializing in chronic kidney disease (CKD), has announced its participation in two major healthcare conferences in September 2025.

The company will present at the Citi Biopharma Back to School Conference in Boston on September 3 at 10:30am ET, and the Morgan Stanley Global Healthcare Conference in New York on September 8 at 7:00am ET. Both presentations will be in a fireside chat format and available via webcast through ProKidney's investor relations website.

ProKidney (NASDAQ: PROK) reported significant regulatory and clinical milestones in Q2 2025. The FDA confirmed eGFR slope as an acceptable surrogate endpoint for rilparencel's accelerated approval in type 2 diabetes and advanced CKD patients. The Phase 2 REGEN-007 study showed promising results with a 78% improvement in eGFR slope in Group 1 patients.

The company's Phase 3 PROACT 1 study has enrolled over 50% of required patients, with topline data expected in Q2 2027. ProKidney ended Q2 with $294.7 million in cash, supporting operations into mid-2027. Q2 financial results showed R&D expenses of $25.9 million (down from $29.4M in Q2 2024) and a net loss of $37.0 million.

ProKidney (Nasdaq: PROK) has achieved a significant regulatory milestone by securing FDA alignment on the accelerated approval pathway for rilparencel, its autologous cellular therapy for chronic kidney disease (CKD) patients with type 2 diabetes. The FDA confirmed that eGFR slope from the ongoing Phase 3 PROACT 1 trial can serve as the surrogate endpoint for accelerated approval.

The FDA agreed that a rilparencel effect size of at least 1.5 mL/min/1.73m2/year improvement versus controls would demonstrate acceptable efficacy. Nearly half of the required patients for accelerated approval analysis have been enrolled, with topline data expected in Q2 2027. The PROACT 1 study will also serve as the confirmatory study for full approval.

ProKidney (Nasdaq: PROK), a late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), has announced its participation in the H.C. Wainwright 4th Annual Kidney Virtual Conference. The company's management team will engage in a fireside chat on Monday, July 14, 2025, at 1:30 PM ET.

Investors can access the live webcast through the Events section of ProKidney's Investor Relations webpage at www.prokidney.com. One-on-one meetings are available through H.C. Wainwright representatives.

ProKidney (NASDAQ: PROK) announced significant positive topline results from its Phase 2 REGEN-007 trial evaluating rilparencel for chronic kidney disease (CKD) and diabetes. In Group 1 (n=24), patients receiving two rilparencel injections showed a 78% improvement in annual eGFR slope decline, from -5.8 to -1.3 mL/min/1.73m2 (p<0.001). Group 2 (n=25), testing a conditional second-dose approach, demonstrated a 50% improvement in kidney function decline.

The therapy demonstrated a favorable safety profile with no rilparencel-related serious adverse events. ProKidney plans to present complete results at ASN's 2025 Kidney Week and has an upcoming FDA Type B meeting to confirm using eGFR slope as a surrogate endpoint for accelerated approval of their ongoing Phase 3 PROACT 1 study.

ProKidney Corp. (Nasdaq: PROK), a late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), has completed its domestication from the Cayman Islands to Delaware, effective July 1, 2025. The change was approved by shareholders at the Annual General Meeting on May 29, 2025.

As part of the transition, Class A and B ordinary shares have automatically converted into corresponding Class A and B common stock of the Delaware corporation. Trading under the new structure will commence on July 2, 2025, maintaining the "PROK" symbol on Nasdaq, with a new CUSIP number of 74291D 104. The company has stated that the domestication will not affect its day-to-day business operations.