News & Videos - PROKIDNEY

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-2027 In 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...

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 43 rd Annual J.P. Morgan Healthcare Conference. The ProKidney management team will also host one-on-one meetings throughout the event. 43 rd Annual J.P. Morgan Healthcare...

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 Conference Date: December 3, 2024 Time: 8:45am ET Format: Fireside Chat Webcast: Link...

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 rilparencel FDA 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...

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, 2024 Time: 10:30am ET Format:...

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...

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 Day Date: Tuesday, October 15, 2024 Time: 9:00am ET...

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 market Discontinued 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...

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 22 nd Annual Global Healthcare Conference, being held in New York, NY on September 4-6, 2024. Morgan Stanley 22 nd Annual Global Healthcare...

Reported interim REGEN-007 data that demonstrate rilparencel’s potential to preserve kidney function in patients with diabetes and advanced CKD Restarted manufacturing and resumed PROACT 1 and PROACT 2 Phase 3 trials Closed $140 million upsized underwritten public offering and concurrent registered direct offering Ended the second quarter with $431.5 million in cash and cash equivalents and marketable securities, supporting operations through projected Phase 3 enrollment completion in mid-2026...

WINSTON-SALEM, N.C., June 17, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease, today announced that it has closed its SEC-registered underwritten public offering and concurrent registered direct offering. ProKidney sold 46,886,452 Class A ordinary shares to the public in the public offering, which includes 4,142,232 Class A ordinary shares pursuant to the...

WINSTON-SALEM, N.C., June 11, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease, today announced the pricing of an underwritten public offering and a concurrent registered direct offering of 53,719,009 shares of its Class A ordinary shares at a price of $2.42 per share, before applicable underwriting discounts and commissions. In addition, the underwriters...

WINSTON-SALEM, N.C., June 10, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease, today announced that it has commenced an underwritten public offering and a concurrent registered direct offering of up to an aggregate of $125 million of its Class A ordinary shares, before deducting underwriting discounts and commissions and other offering expenses. ProKidney...

Interim results of REGEN-007 Phase 2 trial show stabilization of kidney function for 18 months Safety profile consistent with prior studies and comparable to kidney biopsy Resumed manufacturing and both PROACT 1 and PROACT 2 Phase 3 trials Management 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),...

WINSTON-SALEM, N.C., May 29, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Jefferies Global Healthcare Conference taking place from June 4 – 6, 2024 in New York, NY. The ProKidney management team will host one-on-one meetings during the event. Interested investors should contact...

WINSTON-SALEM, N.C., May 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), will host a virtual KOL event on Tuesday, May 28, 2024 at 8:00 AM ET, featuring Steven G. Coca, DO, MS (Icahn School of Medicine at Mount Sinai) and Arnold L. Silva, MD, PhD (University of Arizona) who will discuss the unmet medical need and current treatment landscape for...

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, 2024 On 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-2024...

Dr. Ulrich Ernst joins as Executive Vice President of Technical Operations with a deep background and expertise in process development and manufacturing of cell therapies Mr. Lucio Tozzi joined in January of 2024 as Senior Vice President of Global Clinical Operations having over 30 years of experience in clinical trial execution WINSTON-SALEM, N.C., March 25, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a leading late clinical-stage cellular...

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...

WINSTON-SALEM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Jefferies Biotech on the Bay Summit being held in Miami on March 12 – 13, 2024. The ProKidney management team will host one-on-one meetings during the event. Interested investors should contact their...