ProKidney Announces Alignment with the FDA on the Accelerated Approval Pathway for Rilparencel
FDA Approval for Rilparencel: The FDA has confirmed that the eGFR slope can be used as a surrogate endpoint for the accelerated approval of rilparencel in patients with chronic kidney disease (CKD) and type 2 diabetes, with topline data expected by Q2 2027.
Ongoing Clinical Trials: ProKidney Corp. is currently enrolling patients in the Phase 3 PROACT 1 study, which may also serve as a confirmatory study for full approval of rilparencel, addressing significant unmet needs in CKD treatment.
Trade with 70% Backtested Accuracy
Analyst Views on PROK
About PROK
About the author
Avant Technologies Drives 67.5% Market Share in Cell Therapy Manufacturing
- Market Transformation: The cell therapy manufacturing sector reached a pivotal inflection point in late 2025, with contract development and manufacturing organizations (CDMOs) capturing 67.5% market share, indicating a shift from boutique R&D to scalable bioprocessing infrastructure, which is driving rapid industry growth.
- Surging Demand: The demand for gene and CAR-T therapies has led to CDMO partnerships rapidly expanding viral vector production and GMP-compliant facilities, overcoming previous bottlenecks that constrained commercial access, significantly enhancing market entry capabilities.
- Investment Opportunity: The regenerative medicine market is projected to surge from $48.45 billion in 2024 to $403.86 billion by 2032, with cell-based therapies representing the fastest-growing segment, creating an urgent investment window, especially as most emerging biotechs trade at steep discounts.
- Technological Innovation: Avant Technologies is advancing cell encapsulation technology through its joint venture Insulinova with SG Austria, aiming to provide efficient long-term treatment solutions for diabetes patients globally, addressing the immune rejection of implanted cells, thereby laying the groundwork for safe and scalable diabetes therapies.
Avant Technologies Drives 67.5% Market Share in Cell Therapy Manufacturing
- Market Transformation: The cell therapy manufacturing sector reached a pivotal inflection point in late 2025, with contract development and manufacturing organizations (CDMOs) capturing 67.5% market share, marking a transition from boutique R&D to scalable bioprocessing infrastructure that accelerates industry growth.
- Surging Demand: The demand for gene and CAR-T therapies has driven CDMO partnerships to rapidly expand viral vector production and GMP-compliant facilities, overcoming previous bottlenecks that constrained commercial access, significantly enhancing market entry speed.
- Investment Opportunity: The regenerative medicine market is projected to surge from $48.45 billion in 2024 to $403.86 billion by 2032, with cell-based therapies representing the fastest-growing segment, creating an urgent investment window, especially as emerging biotechs trade at steep discounts.
- Technological Innovation: Avant Technologies is advancing cell encapsulation technology through its joint venture Insulinova with SGAustria, aiming to provide effective long-term treatments for diabetes patients globally, addressing the immune rejection of implanted cells, thereby significantly improving patients' quality of life.
PROKIDNEY CORP. Reports Smaller Q3 Loss, Surpassing Expectations
Earnings Report: PROKIDNEY CORP. reported a loss of $16.47 million for the third quarter, an improvement from a loss of $17.91 million in the same period last year.
Earnings Per Share: The company's earnings per share (EPS) were -$0.12, compared to -$0.14 in the previous year, beating analysts' expectations of -$0.14 per share.
ProKidney Announces Financial Results for Q3 2025 Along with Regulatory and Clinical Updates
Phase 2 Study Results: ProKidney Corp. presented full results from the Phase 2 REGEN-007 study at ASN Kidney Week 2025, showing that rilparencel significantly improved kidney function in patients with advanced chronic kidney disease (CKD) and diabetes, with 63% of patients meeting key inclusion criteria for the ongoing Phase 3 PROACT 1 study.
Phase 3 PROACT 1 Update: The FDA has confirmed that the eGFR slope can be used as a surrogate endpoint for the accelerated approval of rilparencel, with more than half of the required patients enrolled and topline results expected in Q2 2027.
Financial Position: As of September 30, 2025, ProKidney reported $272 million in cash and equivalents, sufficient to fund operations into mid-2027, while also noting a decrease in research and development expenses compared to the previous year.
Chronic Kidney Disease Context: CKD affects approximately 37 million adults in the U.S., with diabetes being the leading cause; ProKidney aims to address the unmet need for effective treatments in patients with advanced CKD and diabetes through its innovative cell therapy, rilparencel.
ProKidney Unveils Comprehensive Findings from Phase 2 REGEN-007 Trial of Rilparencel at the 2025 American Society of Nephrology Kidney Week
Rilparencel's Efficacy: In a Phase 2 trial, rilparencel significantly slowed the progression of chronic kidney disease (CKD) in patients with diabetes, showing a 78% improvement in the annual decline of estimated glomerular filtration rate (eGFR) in one treatment group.
Safety Profile: The treatment was well tolerated with no serious adverse events related to rilparencel, maintaining a safety profile consistent with previous studies.
Phase 3 Study Update: ProKidney's ongoing Phase 3 PROACT 1 study has enrolled over half of the required patients, with topline results expected in Q2 2027, as the FDA has confirmed eGFR slope as an acceptable endpoint for accelerated approval.
Significance of Rilparencel: Rilparencel is the only cell therapy currently in a Phase 3 clinical study for CKD and type 2 diabetes, representing a potential novel treatment option for patients facing limited therapeutic alternatives.
ProKidney Reveals Two Abstracts Chosen for Presentation at the 2025 Kidney Week of the American Society of Nephrology
ProKidney's Presentation at ASN Kidney Week: ProKidney Corp. will present two posters, including a late-breaking poster on the Phase 2 REGEN-007 study results, at the American Society of Nephrology's Kidney Week from November 6-9, 2025, in Houston, TX.
Focus on Chronic Kidney Disease: The company specializes in cellular therapeutics for chronic kidney disease, with its lead product candidate, rilparencel, currently being evaluated in a Phase 3 study aimed at preserving kidney function in patients with advanced CKD and type 2 diabetes.
Avant Technologies Drives 67.5% Market Share in Cell Therapy Manufacturing
- Market Transformation: The cell therapy manufacturing sector reached a pivotal inflection point in late 2025, with contract development and manufacturing organizations (CDMOs) capturing 67.5% market share, indicating a shift from boutique R&D to scalable bioprocessing infrastructure, which is driving rapid industry growth.
- Surging Demand: The demand for gene and CAR-T therapies has led to CDMO partnerships rapidly expanding viral vector production and GMP-compliant facilities, overcoming previous bottlenecks that constrained commercial access, significantly enhancing market entry capabilities.
- Investment Opportunity: The regenerative medicine market is projected to surge from $48.45 billion in 2024 to $403.86 billion by 2032, with cell-based therapies representing the fastest-growing segment, creating an urgent investment window, especially as most emerging biotechs trade at steep discounts.
- Technological Innovation: Avant Technologies is advancing cell encapsulation technology through its joint venture Insulinova with SG Austria, aiming to provide efficient long-term treatment solutions for diabetes patients globally, addressing the immune rejection of implanted cells, thereby laying the groundwork for safe and scalable diabetes therapies.
Avant Technologies Drives 67.5% Market Share in Cell Therapy Manufacturing
- Market Transformation: The cell therapy manufacturing sector reached a pivotal inflection point in late 2025, with contract development and manufacturing organizations (CDMOs) capturing 67.5% market share, marking a transition from boutique R&D to scalable bioprocessing infrastructure that accelerates industry growth.
- Surging Demand: The demand for gene and CAR-T therapies has driven CDMO partnerships to rapidly expand viral vector production and GMP-compliant facilities, overcoming previous bottlenecks that constrained commercial access, significantly enhancing market entry speed.
- Investment Opportunity: The regenerative medicine market is projected to surge from $48.45 billion in 2024 to $403.86 billion by 2032, with cell-based therapies representing the fastest-growing segment, creating an urgent investment window, especially as emerging biotechs trade at steep discounts.
- Technological Innovation: Avant Technologies is advancing cell encapsulation technology through its joint venture Insulinova with SGAustria, aiming to provide effective long-term treatments for diabetes patients globally, addressing the immune rejection of implanted cells, thereby significantly improving patients' quality of life.
PROKIDNEY CORP. Reports Smaller Q3 Loss, Surpassing Expectations
Earnings Report: PROKIDNEY CORP. reported a loss of $16.47 million for the third quarter, an improvement from a loss of $17.91 million in the same period last year.
Earnings Per Share: The company's earnings per share (EPS) were -$0.12, compared to -$0.14 in the previous year, beating analysts' expectations of -$0.14 per share.
ProKidney Announces Financial Results for Q3 2025 Along with Regulatory and Clinical Updates
Phase 2 Study Results: ProKidney Corp. presented full results from the Phase 2 REGEN-007 study at ASN Kidney Week 2025, showing that rilparencel significantly improved kidney function in patients with advanced chronic kidney disease (CKD) and diabetes, with 63% of patients meeting key inclusion criteria for the ongoing Phase 3 PROACT 1 study.
Phase 3 PROACT 1 Update: The FDA has confirmed that the eGFR slope can be used as a surrogate endpoint for the accelerated approval of rilparencel, with more than half of the required patients enrolled and topline results expected in Q2 2027.
Financial Position: As of September 30, 2025, ProKidney reported $272 million in cash and equivalents, sufficient to fund operations into mid-2027, while also noting a decrease in research and development expenses compared to the previous year.
Chronic Kidney Disease Context: CKD affects approximately 37 million adults in the U.S., with diabetes being the leading cause; ProKidney aims to address the unmet need for effective treatments in patients with advanced CKD and diabetes through its innovative cell therapy, rilparencel.
ProKidney Unveils Comprehensive Findings from Phase 2 REGEN-007 Trial of Rilparencel at the 2025 American Society of Nephrology Kidney Week
Rilparencel's Efficacy: In a Phase 2 trial, rilparencel significantly slowed the progression of chronic kidney disease (CKD) in patients with diabetes, showing a 78% improvement in the annual decline of estimated glomerular filtration rate (eGFR) in one treatment group.
Safety Profile: The treatment was well tolerated with no serious adverse events related to rilparencel, maintaining a safety profile consistent with previous studies.
Phase 3 Study Update: ProKidney's ongoing Phase 3 PROACT 1 study has enrolled over half of the required patients, with topline results expected in Q2 2027, as the FDA has confirmed eGFR slope as an acceptable endpoint for accelerated approval.
Significance of Rilparencel: Rilparencel is the only cell therapy currently in a Phase 3 clinical study for CKD and type 2 diabetes, representing a potential novel treatment option for patients facing limited therapeutic alternatives.
ProKidney Reveals Two Abstracts Chosen for Presentation at the 2025 Kidney Week of the American Society of Nephrology
ProKidney's Presentation at ASN Kidney Week: ProKidney Corp. will present two posters, including a late-breaking poster on the Phase 2 REGEN-007 study results, at the American Society of Nephrology's Kidney Week from November 6-9, 2025, in Houston, TX.
Focus on Chronic Kidney Disease: The company specializes in cellular therapeutics for chronic kidney disease, with its lead product candidate, rilparencel, currently being evaluated in a Phase 3 study aimed at preserving kidney function in patients with advanced CKD and type 2 diabetes.
