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ProKidney Corp. develops rilparencel, also described as REACT or Renal Autologous Cell Therapy, as an autologous cell therapy candidate for patients with advanced chronic kidney disease and diabetes. News about PROK centers on clinical data from REGEN-007, Phase 3 PROACT 1/REGEN-006 development, regulatory interactions with the FDA on the use of eGFR slope in an accelerated approval pathway, and scientific presentations in nephrology forums.
Company updates also cover quarterly and annual financial results, cash runway commentary, investor conference participation, and leadership additions tied to commercial planning for rilparencel.
ProKidney (Nasdaq: PROK) reported Q1 2026 results and CKD program progress. The company remains on track to complete enrollment for the Phase 3 PROACT 1 surrogate eGFR endpoint in mid-2026, with pivotal topline data expected in Q2 2027.
ProKidney ended Q1 2026 with $224.9 million in cash, cash equivalents and marketable securities, which it expects will fund operations into mid-2027. Phase 2 REGEN-007 results, including a 4.6 mL/min/1.73m² eGFR slope improvement in Group 1, were published in CJASN.
ProKidney (Nasdaq: PROK) appointed Greg Madison as Chief Commercial Officer on March 25, 2026. Mr. Madison brings more than two decades of commercial and executive biopharma experience, with prior CEO roles and deep nephrology expertise.
He will lead commercial strategy as ProKidney advances rilparencel toward potential commercialization, leveraging prior product launches and business development experience.
ProKidney (Nasdaq: PROK) reported full-year 2025 results and business highlights on March 18, 2026. Key points: $270.0M cash and marketable securities at year-end; positive Phase 2 REGEN-007 data; FDA alignment on an accelerated approval pathway using eGFR slope; Phase 3 PROACT 1 enrollment accelerating with pivotal readout expected Q2 2027.
Management expects existing cash to fund operations into mid-2027 and plans BLA submission in Q4 2027 with potential approval and commercial launch in 2H 2028.
ProKidney (Nasdaq: PROK) announced that CEO Bruce Culleton, M.D. will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 8:15am PST.
The management team will host one-on-one meetings during the event. A live webcast will be available via the company’s Investor Relations "Events" page and at www.prokidney.com. A replay will be accessible for 30 days after the presentation.
ProKidney (NASDAQ: PROK) reported Q3 2025 results and clinical updates on Nov 10, 2025. The company ended Q3 with $271.7M in cash and marketable securities, which management says funds operations into mid-2027. Full Phase 2 REGEN-007 results presented at ASN Kidney Week 2025 showed Group 1 bilateral rilparencel injections improved annual eGFR slope by 4.6 mL/min/1.73m2 (78%, p<0.001); a Phase 3–eligible subgroup (63% of Group 1) showed a 5.5 mL/min/1.73m2 improvement (85%, p=0.005). The FDA agreed eGFR slope can serve as a surrogate endpoint for accelerated approval; >50% of ~360 patients required for the accelerated analysis were enrolled as of Aug 2025 with topline data expected in Q2 2027.
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.