Full data from Group 1 in the Phase 2 REGEN-007 study expected in Q2 2025FDA previously confirmed in a Q4 2024 Type B meeting that the accelerated approval pathway is available for rilparencel; additional details on the accelerated pathway are expected in mid-2025 after our planned Type B meeting with the FDAEnded the first quarter with $328.5 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027 WINSTON-SALEM, N.C., May 12, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported financial results

Significant progress was made in 2024, including refining the Phase 3 program to accelerate rilparencel's path to market in the U.S., the release of positive Phase 2 data, restarting manufacturing, and securing $140 million of equity to extend cash runway into mid-2027In Q4 2024, the FDA confirmed in a Type B meeting that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, which may include eGFR slope, is used; additional details expected in mid-2025Full data from Group 1 in the Phase 2 REGEN-007 study expected in Q2 2025; interim data from June 2024 showed kidney function stabilization for 18 months in patients with advanced CKD and diabetesEnd

WINSTON-SALEM, N.C., Jan. 07, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced that ProKidney's CEO, Bruce Culleton, M.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference. The ProKidney management team will also host one-on-one meetings throughout the event. 43rd Annual J.P. Morgan Healthcare ConferenceDate:January 15, 2025Time:7:30am PSTFormat:PresentationWebcast:Link   The live webcast will also be accessible through the "Events" section of the Investor Relations tab within ProKidney's website

WINSTON-SALEM, N.C., Nov. 26, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the following two upcoming healthcare conferences in December: Evercore HealthCONx ConferenceDate:December 3, 2024Time:8:45am ETFormat:Fireside ChatWebcast:Link  Citi Global Healthcare ConferenceDate:December 4, 2024Format:One-on-one meetings   The live webcast for the Evercore fireside chat will be accessible through the "Events" section of the Investor Relations tab w

FDA confirmed in a recent FDA Type B meeting under RMAT designation that the PROACT 1 Phase 3 study could be sufficient to support a full U.S. regulatory approval of rilparencelFDA also confirmed in that Type B meeting that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, which may include eGFR slope, is used Presented five posters at the ASN Kidney Week, including one late-breaking clinical trial and four posters on rilparencel's product characterization and MOAEnded the third quarter with $406.8 million in cash and cash equivalents and marketable securities, supporting operations into 2027 WINSTON-SALEM, N.C

WINSTON-SALEM, N.C., Nov. 05, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced that senior members of the management team will be participating in two upcoming healthcare conferences in November. Guggenheim Inaugural Healthcare Innovation Conference (Boston)Date:Wed, November 13, 2024Time:10:30am ETFormat:Fireside ChatWebcast:Link  Jefferies London Healthcare ConferenceDate:Wed, November 20, 2024Time:10:00am GMTFormat:Fireside ChatWebcast:Link   The live webcasts will also be accessible through the "Events" sectio

WINSTON-SALEM, N.C., Oct. 14, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that the Company will present five posters, including one late-breaking clinical trial, at the upcoming American Society of Nephrology's (ASN) Kidney Week being held on October 23-27, 2024, in San Diego, CA. The titles for the accepted abstracts are provided below and accessible online at: https://www.asn-online.org/education/kidneyweek/2024/program-search-abstract.aspx Late-Breaking Poster Presentation Rilparencel Autologous Cell Therapy in Patients with D

WINSTON-SALEM, N.C., Oct. 09, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the UBS Virtual Organ Restoration Day, which will be taking place on October 15, 2024. UBS Virtual Organ Restoration DayDate: Tuesday, October 15, 2024Time: 9:00am ETFormat:  Fireside ChatWebcast Link: https://kvgo.com/ubs/prokidney-oct-2024     The live webcast will also be accessible through the "Events" section of the Investor Relations tab within ProKidney's websi

Refined the focus of the Phase 3 program to accelerate path to potential U.S. approval and commercial launch in the Company's highest priority marketDiscontinued the ex-U.S.-based PROACT 2 trial and focused Company resources on PROACT 1 to expedite enrollment and accelerate estimated topline data readout to Q3 2027 WINSTON-SALEM, N.C., Sept. 03, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced strategic updates to its Phase 3 program for rilparencel, an investigational treatment to potentiall

WINSTON-SALEM, N.C., Aug. 27, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a leading late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Morgan Stanley 22nd Annual Global Healthcare Conference, being held in New York, NY on September 4-6, 2024. Morgan Stanley 22nd Annual Global Healthcare ConferenceDate:Thursday, September 5, 2024Time:7:00 a.m. ETFormat:Fireside ChatWebcast Link:https://cc.webcasts.com/morg007/090424a_js/?entity=120_8TXT47O   The live webcast will also be accessible through t

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JP Morgan initiated coverage of ProKidney Corp. with a rating of Neutral

Guggenheim initiated coverage of ProKidney Corp. with a rating of Buy and set a new price target of $6.00

Morgan Stanley resumed coverage of ProKidney Corp. with a rating of Equal-Weight and set a new price target of $3.00

BofA Securities downgraded ProKidney Corp. from Buy to Neutral

BTIG Research initiated coverage of ProKidney Corp. with a rating of Buy and set a new price target of $16.00

Jefferies initiated coverage of ProKidney Corp. with a rating of Buy and set a new price target of $15.00

Morgan Stanley initiated coverage of ProKidney Corp. with a rating of Equal-Weight and set a new price target of $13.00

UBS initiated coverage of ProKidney Corp. with a rating of Buy and set a new price target of $18.00

Citigroup initiated coverage of ProKidney Corp. with a rating of Buy and set a new price target of $16.00

BofA Securities initiated coverage of ProKidney Corp. with a rating of Buy and set a new price target of $14.00

Interim results of REGEN-007 Phase 2 trial show stabilization of kidney function for 18 monthsSafety profile consistent with prior studies and comparable to kidney biopsyResumed manufacturing and both PROACT 1 and PROACT 2 Phase 3 trialsManagement to host live webcast today at 8:00 a.m. ET WINSTON-SALEM, N.C., June 10, 2024 (GLOBE NEWSWIRE) --  ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced positive interim results from the Phase 2 REGEN-007 trial evaluating the Company's renal autologous cell therapy, rilparencel, in patients with CKD caused by diabetes and provided clinical

WINSTON-SALEM, N.C., Nov. 14, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the third quarter ended September 30, 2023. "Building off of our positive corporate update, and with nearly $400 million in cash, cash equivalents and marketable securities as of September 30th of this year, ProKidney continues to be well capitalized to continue executing on both of our Phase 2 and Phase 3 trials in high-risk CKD patients in need," said James Coulston, Chief Financial Officer at ProKidney. "With cash expected to fund operations into the

Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients Focusing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy Dr. Bruce Culleton appointed ProKidney CEO following Dr. Tim Bertram's transition to advisory role Sufficient capital to fund operations into fourth quarter 2025 ProKidney to host conference call and webcast tomorrow at 8:00 a.m. ET WINSTON-SALEM, N.C., Nov. 13, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a leading late clinical-stage cellu

Refined the focus of the Phase 3 program to accelerate path to potential U.S. approval and commercial launch in the Company's highest priority marketDiscontinued the ex-U.S.-based PROACT 2 trial and focused Company resources on PROACT 1 to expedite enrollment and accelerate estimated topline data readout to Q3 2027 WINSTON-SALEM, N.C., Sept. 03, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced strategic updates to its Phase 3 program for rilparencel, an investigational treatment to potentiall

Final results from RMCL-002 Phase 2 trial to be presented in the Late Breaking Clinical Trials session at the European Renal Association (ERA) Congress on May 25, 2024. An investor call to provide a perspective on CKD with Dr. Arnold Silva and Dr. Steven Coca and a recap of the RMCL-002 data is planned for May 28, 2024On schedule to resume manufacturing and PROACT 1 Phase 3 trial, commence PROACT 2 Phase 3 trial, and readout interim results from the ongoing REGEN-007 Phase 2 trial in mid-2024Strengthened leadership team with appointment of two key hires across Clinical and Technical OperationsEnded the first quarter with $329 million in cash and cash equivalents and marketable securities, su

WINSTON-SALEM, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the year ended December 31, 2023. "We are very excited about the future of ProKidney. Building on the positive interim Phase 2 data that we released last Fall for rilparencel (which we sometimes refer to as REACT®) demonstrating the potential to preserve kidney function in patients with type 2 diabetes mellitus and advanced kidney disease, we look forward to the REGEN-007 Phase 2 interim data readout mid-year," said Bruce Culleton, Ch

WINSTON-SALEM, N.C., Nov. 30, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced the appointment of Nikhil Pereira-Kamath, MBA, Vice President of Business Development & Innovative Solutions, to Chief Business Officer (CBO). As CBO, Nikhil will have global responsibility for commercial strategy, defining the Company's growth and partnering activities, business development, and investor relations. "Nik's broad experience in new business development and strategic partnerships will be an invaluable asset as the Company moves through late-stage clinical develo

- Brings more than 20 years of academic and industry experience with extensive expertise in kidney disease - WINSTON-SALEM, N.C., July 17, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced the appointment of Bruce Culleton, MD, as Executive Vice President, Clinical Development and Commercialization. Dr. Culleton, who will report to Chief Executive Officer Tim Bertram, joins ProKidney after more than two decades in industry and academia with a primary focus on kidney health. Tim Bertram, Chief Executive Officer of ProKidney, said: "I am

Brings nearly 20 years of investor relations and corporate communications experience to ProKidney WINSTON-SALEM, N. C., Aug. 31, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced the appointment of Glenn Schulman, PharmD, MPH, as Senior Vice President of Investor Relations. Dr. Schulman, who will report to Chief Financial Officer James Coulston, joins ProKidney after leading investor relations and corporate communication efforts at a number of early and late-stage Nasdaq-listed biopharmaceutical companies focused on the development of therapies to treat

Maraganore brings more than 35 years of scientific, research and development, capital markets and managerial leadership expertise to ProKidney Fox joins Board with more than 25 years of healthcare investment banking, finance and capital markets experience WINSTON-SALEM, N.C., Aug. 11, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (NASDAQ:PROK) ("ProKidney" or the "Company"), a leading clinical-stage cellular therapeutics company focused on therapies for chronic kidney disease ("CKD"), today announced the appointments of John M. Maraganore, Ph.D. and Jennifer Fox to its Board of Directors. "We are thrilled to welcome John and Jen to the ProKidney Board. They each have a wealth of experience t