FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetesFDA also confirmed that the ongoing Phase 3 PROACT 1 study can be used for both accelerated approval and for full approvalNearly half of the patients required for the accelerated approval analysis using eGFR slope have been enrolledTopline data to support an application for accelerated approval is anticipated in Q2 2027 WINSTON-SALEM, N.C., July 15, 2025 (GLOBE NE ...

Core Viewpoint - ProKidney Corp. is actively engaging with investors through participation in the H.C. Wainwright 4 Annual Kidney Virtual Conference, highlighting its focus on chronic kidney disease and its innovative cellular therapy approach [1]. Company Overview - ProKidney Corp. is a pioneer in chronic kidney disease treatment through cellular therapy innovations, founded in 2015 after a decade of research [2]. - The company's lead product candidate, rilparencel (REACT), is a first-in-class autologous cellular therapy currently in Phase 2 and Phase 3 studies aimed at preserving kidney function in diabetic patients at high risk of kidney failure [2]. - Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, indicating its potential significance in the treatment landscape [2].

Core Insights - ProKidney Corp. reported positive topline results from the Phase 2 REGEN-007 trial of rilparencel, showing significant improvement in kidney function for patients with chronic kidney disease (CKD) and diabetes [1][3][4] Group 1: Trial Results - In Group 1 (n=24), the annual decline in estimated glomerular filtration rate (eGFR) improved by 78%, from -5.8 mL/min/1.73m² to -1.3 mL/min/1.73m² after rilparencel injections, with a statistically significant difference of 4.6 mL/min/1.73m² per year (p<0.001) [3] - Of the 24 patients in Group 1, 15 (63%) met the key Phase 3 PROACT 1 inclusion criteria, showing similar efficacy results to the full Group 1 [4] Group 2: Additional Findings - In Group 2 (n=25), the eGFR slope improved by 50%, from -3.4 mL/min/1.73m² to -1.7 mL/min/1.73m², with a 1.7 mL/min/1.73m² per year difference that was not statistically significant (p=0.085) [5] - Of the 25 patients in Group 2, 15 (60%) received a second rilparencel injection after approximately 11 months, with no serious adverse events reported [6] Regulatory and Market Response - An FDA Type B meeting is scheduled for this summer to discuss the use of eGFR slope as a surrogate endpoint in the ongoing Phase 3 PROACT 1 study, aiming for accelerated approval [7] - Following the announcement, PROK stock rose by 56.6% to $0.95 during the premarket session [7]

PolTREG Establishes U.S. Subsidiary Immuthera to Advance International Development Strategy PolTREG established Immuthera (https://immuthera.bio/) in Delaware to expand its presence in the U.S. market. A Pre-IND application was submitted to the FDA.The Paediatric Committee (PDCO) of the European Medicines Agency issued a positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1). Gdańsk, Poland – 13 JUNE 2025 – PolTREG S.A. (Warsaw Stock Exch ...

Core Insights - ProKidney Corp. reported financial results for Q1 2025, highlighting its focus on chronic kidney disease (CKD) and upcoming milestones in clinical trials [1][2] Financial Highlights - As of March 31, 2025, ProKidney had cash, cash equivalents, and marketable securities totaling $328.5 million, down from $358.3 million at the end of 2024, which is expected to fund operations into mid-2027 [4][8] - Research and development expenses were $27.3 million for Q1 2025, slightly up from $27.2 million in Q1 2024, with increases in cash compensation and facility costs offset by a decrease in clinical trial costs [5] - General and administrative expenses rose to $14.4 million in Q1 2025 from $12.8 million in Q1 2024, primarily due to higher cash compensation and professional fees [6] - The net loss before noncontrolling interest was $38.0 million for Q1 2025, compared to $35.3 million for the same period in 2024 [7] Clinical Development - The company is approaching key milestones, including the release of full Group 1 data from the Phase 2 REGEN-007 study and a regulatory update on the accelerated approval pathway for rilparencel following a Type B meeting with the FDA [2][8] - Full data from Group 1 of the Phase 2 REGEN-007 study is expected in Q2 2025, involving approximately 20 patients with an average follow-up of 18 months [9] - The Phase 3 REGEN-006 (PROACT 1) clinical trial is ongoing, focusing on patients with type 2 diabetes and advanced CKD, with a total planned enrollment of approximately 685 subjects [10] Company Overview - ProKidney Corp. specializes in cellular therapeutics for chronic kidney disease, with its lead product candidate, rilparencel, being evaluated in late-stage clinical trials [12]

Increased survival and reduced major adverse cardiac and cerebrovascular events (MACCE) observed study-wide, despite primary composite efficacy endpoint not reaching statistical significance Statistically significant improvement in composite outcome measure comprised of survival, MACCE, and quality of life seen in patients suffering from active heart stress (those with elevated NTproBNP and BNP biomarkers) treated with CardiAMP Cell Therapy Patient improvements through two years suggest single dose of Cardi ...

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q4 2024 Earnings Conference Call March 19, 2025 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marban - Chief Executive Officer Conference Call Participants Edward Tenthoff - Piper Sandler Leland Gershell - Oppenheimer Joseph Pantginis - H.C. Wainwright Kristen Kluska - Cantor Fitzgerald Catherine Novack - JonesTrading Aydin Huseynov - Ladenburg Madison El-Saadi - B. Riley Securities Operator Good afternoon, ladies and gentlemen, and w ...