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 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.
ProKidney (NASDAQ: PROK) has reported its Q1 2025 financial results and business updates. The company ended Q1 with $328.5 million in cash and equivalents, providing runway into mid-2027. Key upcoming milestones include full data from Group 1 of Phase 2 REGEN-007 study in Q2 2025, comprising ~20 patients with two rilparencel injections and 18-month follow-up.
The FDA confirmed in Q4 2024 that an accelerated approval pathway is available for rilparencel, with additional details expected mid-2025. Q1 financial results showed R&D expenses at $27.3 million, relatively flat year-over-year, while G&A expenses increased to $14.4 million from $12.8 million. Net loss widened to $38.0 million from $35.3 million in the prior year.
ProKidney (PROK) reported its full year 2024 financial results, highlighting significant progress in its clinical programs for rilparencel, a treatment for chronic kidney disease (CKD). The FDA confirmed in Q4 2024 that an accelerated approval pathway is available using eGFR slope as a potential surrogate endpoint.
Key financial metrics include:
- Cash position of $358.3 million as of December 31, 2024, expected to fund operations into mid-2027
- R&D expenses increased to $127.7 million from $106.7 million in 2023
- G&A expenses rose to $56.1 million from $44.8 million in 2023
- Net loss widened to $163.3 million from $135.4 million in 2023
The company secured $140 million in equity funding and expects full data from Phase 2 REGEN-007 study Group 1 in Q2 2025. Interim results from June 2024 showed kidney function stabilization for 18 months in patients with advanced CKD and diabetes.
ProKidney Corp (Nasdaq: PROK), a late clinical-stage biotech company specializing in cell therapy for chronic kidney disease (CKD), has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. CEO Bruce Culleton, M.D., will deliver a presentation on January 15, 2025, at 7:30am PST.
The company's management team will be available for one-on-one meetings during the event. Interested parties can access the live webcast through the 'Events' section of ProKidney's Investor Relations webpage at www.prokidney.com. A replay of the presentation will remain available for 90 days following the event.
ProKidney Corp (Nasdaq: PROK), a late clinical-stage biotech company developing cell therapy for chronic kidney disease (CKD), has announced its participation in two major healthcare conferences this December. The company will join the Evercore HealthCONx Conference on December 3, 2024, featuring a fireside chat at 8:45am ET with a live webcast available. Additionally, ProKidney will participate in the Citi Global Healthcare Conference on December 4, 2024, conducting one-on-one meetings.
The Evercore fireside chat webcast will be accessible through ProKidney's website investor relations section. Interested investors can arrange meetings through their Evercore and Citi representatives.
ProKidney (PROK) reported Q3 2024 financial results and regulatory updates. The FDA confirmed in a Type B meeting that the PROACT 1 Phase 3 study could support full U.S. regulatory approval of rilparencel, and that accelerated approval pathway is available using eGFR slope as a surrogate endpoint. The company ended Q3 with $406.8 million in cash and equivalents, supporting operations into 2027. R&D expenses decreased to $31.3 million from $32.2 million year-over-year, while G&A expenses increased to $17.7 million from $14.4 million. Net loss was $41.1 million, slightly improved from $42.0 million in Q3 2023.
ProKidney Corp (Nasdaq: PROK), a late clinical-stage biotech company developing cell therapy for chronic kidney disease (CKD), announced its participation in two major healthcare conferences this November. The company will present at the Guggenheim Inaugural Healthcare Innovation Conference in Boston on November 13, 2024, at 10:30am ET, and the Jefferies London Healthcare Conference on November 20, 2024, at 10:00am GMT.
Both presentations will be in a fireside chat format, with live webcasts available through ProKidney's website. Replays will be accessible for 90 days after the events. The management team will also conduct one-on-one meetings with investors during both conferences.
ProKidney Corp. (Nasdaq: PROK), a late clinical-stage biotech company focusing on developing a first-in-class cell therapy for chronic kidney disease (CKD), has announced its participation in the UBS Virtual Organ Restoration Day on October 15, 2024. Senior management team members will engage in a fireside chat at 9:00am ET.
The event will be accessible via a live webcast, with a link provided for public viewing. Additionally, the webcast will be available through ProKidney's website in the 'Events' section of the Investor Relations tab. A replay will remain accessible for 90 days following the event.
ProKidney's management team will also conduct one-on-one meetings with investors during the event. Interested parties are advised to contact their UBS representative to arrange these meetings.
ProKidney Corp. (Nasdaq: PROK) has announced strategic updates to its Phase 3 program for rilparencel, a potential treatment for chronic kidney disease (CKD) in patients with type 2 diabetes. The company has decided to discontinue the ex-U.S.-based PROACT 2 trial and focus resources on PROACT 1 to accelerate enrollment and data readout, now estimated for Q3 2027. This decision follows a comprehensive review and engagement with regulatory experts.
ProKidney believes rilparencel is eligible for initial FDA approval under an expedited pathway based on the PROACT 1 trial, leveraging its Regenerative Medicine Advanced Therapy (RMAT) designation. This strategic shift is expected to reduce expenses by $150-$175 million and extend the company's cash runway into Q1 2027. The company aims to prioritize the U.S. market, where there is high unmet clinical and economic need for advanced CKD treatments.
ProKidney Corp. (Nasdaq: PROK), a leading late clinical-stage biotech company focused on developing a first-in-class cell therapy for chronic kidney disease (CKD), has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will take place in New York, NY from September 4-6, 2024.
Key details:
- Date: Thursday, September 5, 2024
- Time: 7:00 a.m. ET
- Format: Fireside Chat
A live webcast will be available through the company's website, with a 90-day replay option after the event. ProKidney's management team will also host one-on-one meetings with interested investors during the conference.
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