ProKidney Corp
NASDAQ:PROK
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ProKidney Corp
ProKidney Corp is a US-based company operating in Biotechnology industry. The company is headquartered in Winston-Salem, North Carolina and currently employs 0 full-time employees. The company went IPO on 2021-06-30. ProKidney Corp., formerly Social Capital Suvretta Holdings Corp. III, is a clinical-stage biotechnology company. The firm is focused on developing a cell therapy platform capable of treating multiple chronic kidney diseases (CKD) using a patient’s own cells isolated from the patient intended for treatment. Its lead product candidate, Renal Autologous Cell Therapy (REACT), is designed to stabilize or improve kidney function in a CKD patient's diseased kidneys. REACT is a product that includes selected renal cells (SRCs) prepared from a patient’s own, autologous, renal cells. The firm is focused on conducting a Phase III development program and multiple Phase II clinical trials for REACT in subjects with moderate to severe diabetic kidney disease.
ProKidney Corp is a US-based company operating in Biotechnology industry. The company is headquartered in Winston-Salem, North Carolina and currently employs 0 full-time employees. The company went IPO on 2021-06-30. ProKidney Corp., formerly Social Capital Suvretta Holdings Corp. III, is a clinical-stage biotechnology company. The firm is focused on developing a cell therapy platform capable of treating multiple chronic kidney diseases (CKD) using a patient’s own cells isolated from the patient intended for treatment. Its lead product candidate, Renal Autologous Cell Therapy (REACT), is designed to stabilize or improve kidney function in a CKD patient's diseased kidneys. REACT is a product that includes selected renal cells (SRCs) prepared from a patient’s own, autologous, renal cells. The firm is focused on conducting a Phase III development program and multiple Phase II clinical trials for REACT in subjects with moderate to severe diabetic kidney disease.
Phase II Data: ProKidney reported promising interim results from its RMCL-002 Phase II trial, showing REACT cell therapy may help preserve kidney function, especially in high-risk stage 4 CKD patients.
Phase III Protocol Change: The company is modifying its proact 1 Phase III trial to focus on sicker CKD patients (eGFR 20–35 ml/min), based on Phase II findings, and increasing enrollment by 600 patients.
Enrollment & Manufacturing Delays: Enrollment in proact 1 and manufacturing are paused to update protocols and address EU regulatory audit issues, with both expected to resume in the first half of 2024.
Safety Profile: REACT therapy continues to show a safety profile similar to kidney biopsy, with no significant treatment-related serious adverse events reported.
Upcoming Catalysts: Final Phase II (002) results and interim data from the 007 trial are expected in the first half and mid-2024, respectively, providing near-term data catalysts.
Financial Position: Management stated the company is well-capitalized into 2025, with several potential financing catalysts ahead.