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ProKidney Corp. - PROK STOCK NEWS

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.

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ProKidney Corp. (Nasdaq: PROK) announced updated positive interim diabetic CKD data from its RMCL-002 Phase 2 study, demonstrating the potential efficacy of REACT® to preserve kidney function in diabetic CKD patients. The company plans to focus its Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure. Dr. Bruce Culleton appointed as ProKidney CEO and the company has sufficient capital to fund operations into fourth quarter 2025.
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ProKidney Corp. will present four posters at the upcoming American Society of Nephrology's Kidney Week. The posters will discuss investigations into the mechanism of action and clinical outcomes observed with REACT®. ProKidney booth will also provide additional information on REACT®.
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ProKidney Corp. CEO to participate in fireside chat at Morgan Stanley Global Healthcare Conference
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ProKidney Corp. announces financial results for Q2 2023, advances REACT development programs, and purchases facility in Greensboro. Cash and marketable securities total $446.1 million. R&D expenses increase to $26.4 million. G&A expenses increase to $13.5 million. Net loss before noncontrolling interest is $34.8 million.
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ProKidney Corp. has appointed Bruce Culleton, MD, as Executive Vice President, Clinical Development and Commercialization. Dr. Culleton brings over 20 years of experience in kidney health and will play a crucial role in the development of REACT® for chronic kidney disease (CKD) patients. Phase 3 clinical development is underway, with initial interim data expected in late 2024.
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ProKidney Corp. has announced its agreement to purchase a facility and land in Greensboro, N.C., for $25.5 million to support the future manufacturing needs of its proprietary REnal Autologous Cell Therapy. The company plans to invest in the facility through 2028 in preparation for potential commercial-scale manufacturing. ProKidney aims to submit a Biological Licensing Agreement for FDA approval of REACT in 2026, with a possible commercial launch in the U.S. later that year. The city of Greensboro and the state of North Carolina have approved an incentive package for ProKidney.
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ProKidney Corp. to present at BofA Securities Health Care Conference 2023
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FAQ

What is the current stock price of ProKidney (PROK)?

The current stock price of ProKidney (PROK) is $1.51 as of December 20, 2024.

What is the market cap of ProKidney (PROK)?

The market cap of ProKidney (PROK) is approximately 185.6M.

What is ProKidney Corp?

ProKidney Corp is a clinical-stage biotechnology company focused on treating chronic kidney disease (CKD) through innovative cellular therapies.

What is REACT™?

REACT™ (Renal Autologous Cell Therapy) is ProKidney's lead product candidate, a patented autologous cellular therapy aimed at modifying the progression of CKD.

What designation has REACT™ received?

REACT™ has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.

What stages of CKD is REACT™ targeting?

REACT™ targets patients with late-stage CKD, specifically stages 3b to 4.

When did ProKidney's Phase 3 trials start?

ProKidney's Phase 3 clinical trials for REACT™ commenced in January 2022.

What recent financial milestone did ProKidney achieve?

As of September 30, 2023, ProKidney reported nearly $400 million in cash, cash equivalents, and marketable securities.

What is the expected cash runway for ProKidney?

ProKidney's existing financial resources are expected to fund operations into the fourth quarter of 2025.

What is the focus of the REGEN-007 trial?

The REGEN-007 trial evaluates the efficacy and safety of REACT™ in patients with diabetes-induced CKD.

Where can I find more information about ProKidney?

For more information, please visit ProKidney's official website at www.prokidney.com.

How can investors contact ProKidney?

Investors can contact ProKidney through Glenn Schulman, SVP Investor Relations, at Glenn.Schulman@prokidney.com or Daniel Ferry at LifeSci Advisors, LLC, via Daniel@lifesciadvisors.com.

ProKidney Corp.

Nasdaq:PROK

PROK Rankings

PROK Stock Data

185.55M
92.75M
27.44%
43.59%
8.36%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
WINSTON-SALEM