Welcome to our dedicated page for ProKidney news (Ticker: PROK), a resource for investors and traders seeking the latest updates and insights on ProKidney stock.
ProKidney Corp. (Nasdaq: PROK) generates frequent news flow as a late clinical-stage biotechnology company focused on chronic kidney disease (CKD) and autologous cellular therapy. News coverage for ProKidney often centers on clinical trial milestones for its lead product candidate, rilparencel (also known as REACT®), regulatory interactions with the U.S. Food and Drug Administration (FDA), and financial and corporate updates relevant to investors following PROK stock.
Readers can expect updates on Phase 2 and Phase 3 studies, including the REGEN-007 and REGEN-006 (PROACT 1) trials in patients with advanced CKD and diabetes. Press releases have highlighted statistically significant and clinically meaningful changes in estimated glomerular filtration rate (eGFR) slope, safety findings such as the absence of rilparencel-related serious adverse events in reported analyses, and FDA confirmation that eGFR slope can serve as a surrogate endpoint for an accelerated approval pathway. These items help investors and observers track the progress of rilparencel through late-stage development.
ProKidney news also includes quarterly financial results, cash runway commentary, and disclosures about research and development and general and administrative expenses. SEC-related announcements, such as at-the-market equity offering arrangements and changes in jurisdiction of incorporation, are commonly reported through press releases and associated Form 8-K filings. In addition, the company regularly announces participation in scientific and investor conferences, including American Society of Nephrology Kidney Week presentations and healthcare investment conferences where senior management discusses clinical data and corporate strategy.
For anyone monitoring PROK news, this stream of clinical, regulatory, financial, and conference-related updates provides insight into ProKidney’s efforts to advance rilparencel as a potential new treatment option for patients with advanced CKD and diabetes and to manage the company’s capital and public market presence.
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.
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.
FAQ
What is the current stock price of ProKidney (PROK)?
What is the market cap of ProKidney (PROK)?
