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) is a leading clinical-stage biotechnology company revolutionizing the treatment of chronic kidney disease (CKD) through its innovative cellular therapy platform. Founded in 2015 after a decade of comprehensive research, ProKidney remains at the forefront of medical advancements aimed at tackling CKD.
The company's flagship product, REACT™ (Renal Autologous Cell Therapy), is a groundbreaking, patented autologous cellular therapy designed to modify the progression of CKD. By utilizing a patient’s own renal cells, REACT™ not only aims to slow and stabilize the disease but also has the potential to significantly improve kidney function in cases reaching stages 3b to 4. This innovative approach has garnered significant attention, earning REACT™ the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and support from both the FDA and EMA for its ongoing Phase 3 clinical trials, which commenced in January 2022.
ProKidney's financial resilience is notable, with nearly $400 million in cash, cash equivalents, and marketable securities as of September 30, 2023. This solid financial foundation is expected to support the company's operations and clinical development initiatives through the fourth quarter of 2025.
Recent milestones include the successful initiation of Phase 3 clinical trials and promising interim data from the Phase 2 REGEN-007 trial, which highlighted REACT™’s potential to preserve kidney function in patients with diabetes-induced CKD. These advancements underscore ProKidney’s commitment to addressing the unmet needs of high-risk CKD patients who face limited treatment options beyond dialysis or transplantation.
The company’s robust pipeline also includes developmental programs targeting severe diabetic kidney disease, reinforcing its leadership position in the biotechnology sector. ProKidney’s strategic partnerships and collaborations, coupled with a dedicated team of experts, continue to drive its mission of bringing life-changing therapies to those affected by chronic kidney disease.
For more information, visit www.prokidney.com.
ProKidney Corp. (Nasdaq: PROK) announced the publication of early data analysis from its Phase 2 clinical trial, REGEN-003, in the Journal of Blood Purification. The study evaluates the effectiveness of Renal Autologous Cell Therapy (REACT) in patients with late-stage diabetic kidney disease. Participants demonstrated a mean dialysis delay of 16 months, with 20% preserving their kidney function after 15 months. The trial focuses on patients unlikely to qualify for transplants, marking a significant step in CKD treatment. ProKidney emphasizes the potential of REACT to improve quality of life for patients.
ProKidney Corp. (Nasdaq: PROK), a leader in cellular therapeutics for chronic kidney disease (CKD), will have its CEO, Dr. Tim Bertram, present at the J.P. Morgan 41st Annual Healthcare Conference on January 11, 2023, at 3:45 PM PT in San Francisco. The webcast will be accessible via their investor relations website. ProKidney is known for its innovative REACT® therapy aimed at preserving kidney function in late-stage CKD, having received FDA's Regenerative Medicine Advanced Therapy designation. CKD affects over 75 million people in the U.S. and Europe.
ProKidney Corp. (Nasdaq: PROK) announced its Q3 2022 financial results, reporting a net loss of $33.9 million, up from $17.1 million in Q3 2021. The company ended the quarter with $506.3 million in cash, following a successful Nasdaq listing that raised $512 million. ProKidney is advancing its REACT® clinical program, with ongoing Phase 3 studies, proact 1 and proact 2, aimed at chronic kidney disease (CKD) treatment. The company anticipates initial data from its Phase 2 study (REGEN-007) by mid-2023. Significant corporate developments include favorable advice from the EMA and the commencement of patient recruitment in the UK.
ProKidney Corp. (Nasdaq: PROK) announced that CEO Dr. Tim Bertram will participate in upcoming investor conferences, including the Jefferies London Healthcare Conference on November 16, 2022, and the Evercore ISI 5th Annual HEALTHCONx Virtual Conference on December 1, 2022. Both events will feature fireside chats available via webcast on ProKidney’s investor relations website. ProKidney specializes in chronic kidney disease (CKD) treatments, focusing on its groundbreaking REACT® therapy, which has received regulatory designations supporting its Phase 3 clinical program.
ProKidney Corp. (Nasdaq: PROK) announced the approval of its Phase 3 proact 1 study protocol for the REACT® candidate by the UK’s MHRA, following FDA approval in the US. The UK sites will start patient recruitment, expanding the clinical trial beyond North America. ProKidney also received positive feedback from the EMA for its Phase 3 development program, critical for a future MAA. The proact program aims to enroll 600 patients and proactively prevent chronic kidney disease progression. Interim results are expected in late 2024 for proact 1.
ProKidney Corp. (Nasdaq: PROK) announced it will present five posters on chronic kidney disease (CKD) during the ASN Annual Meeting in Orlando, FL, from November 3-6, 2022. Topics include CKD prevalence, gender differences in progression, and the effects of SGLT2 inhibitors. The company will hold an investor briefing on November 3. The lead product candidate, REACT™, aims to slow CKD progression and has received RMAT designation. CKD affects approximately 75 million people in the U.S. and Europe, with significant healthcare costs associated.
ProKidney Corp. (Nasdaq: PROK) announced that CEO Dr. Tim Bertram will present a corporate overview at the Jefferies Cell and Genetic Medicine Summit on September 29, 2022, at 1:30 p.m. ET in New York, NY. Investors can access the live webcast via ProKidney's investor relations website. The company focuses on cellular therapeutics for chronic kidney disease (CKD), particularly their lead product REACT™, which has received RMAT designation and supports ongoing Phase 3 clinical trials. CKD affects approximately 75 million people in the U.S. and Europe, posing significant health risks.
ProKidney Corp. (Nasdaq: PROK) announced that CEO Dr. Tim Bertram will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 14, 2022, in New York, NY. The discussion will cover commercialization strategies, cost reduction, and manufacturing scalability for their lead product REACT™, a novel therapy for chronic kidney disease (CKD). A live webcast will be available on their investor relations site. ProKidney aims to slow CKD progression and improve kidney function through innovative cellular therapies.
ProKidney Corp. (Nasdaq: PROK) has appointed Glenn Schulman as Senior Vice President of Investor Relations, effective immediately. With nearly 20 years of experience in investor relations and corporate communications, Schulman aims to enhance ProKidney's visibility and shareholder value as it advances its lead product, REACT™, through clinical development. REACT™ is a patented cellular therapy for chronic kidney disease, currently in Phase 3 trials. CFO James Coulston expressed confidence in Schulman's expertise to foster long-term success for the company.
ProKidney Corp. (Nasdaq: PROK) reported financial results for Q2 2022 following its business combination with Social Capital Suvretta Holdings. The company secured $596.5 million in gross proceeds to support its Phase 3 program for REACT™, aimed at treating chronic kidney disease (CKD). As of June 30, 2022, ProKidney's cash and equivalents were $21.9 million, up from $20.6 million at the end of 2021. R&D expenses rose to $11.6 million, while G&A expenses surged to $9.2 million. The diluted net loss per share stood at $(0.12), compared to $(0.09) in Q2 2021.
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