Prokidney Corp. PROK
Prokidney Corp. (Nasdaq: PROK) is a cardio-renal-metabolic drug developer. Its lead program, rilparencel (autologous Selected Renal Cells), is in Phase 3 for advanced chronic kidney disease with type 2 diabetes. Its next catalyst on record is rilparencel: PROACT 1 topline readout of surrogate endpoint (eGFR slope) supporting potential accelerated approval (Q2 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: rilparencel — PROACT 1 topline readout of surrogate endpoint (eGFR slope) supporting potential accelerated approval (Q2 2027). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| rilparencel, REGEN-006 (PROACT 1) | advanced CKD (Stage 4 and late Stage 3b) with type 2 diabetes; Phase 3, ~470 patients, RMAT designation | cell therapy | Phase 3 |
| rilparencel, REGEN-007 | CKD with diabetes (Phase 2 completed May 2025) | cell therapy | Phase 2 |
Recent results and decisions
- Aug 10, 2026completed enrollment Completed enrollment of the ~320 patients contributing to the PROACT 1 accelerated-approval eGFR slope analysis; full ~470-patient enrollment on track for 2H 2026.
Completed enrollment of patients contributing to the accelerated approval efficacy analysis, which is expected to include approximately 320 patients
Filing - Nov 6, 2025positive Full Phase 2 REGEN-007 results at ASN: Group 1 (n=24) eGFR slope improved by 4.6 mL/min/1.73m2 per year (78%, p<0.001); 63% of Group 1 met PROACT 1 criteria with 5.5 mL/min/1.73m2 improvement (p=0.005).
In Group 1 (n=24), bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 improvement in the annual decline in eGFR slope; this 78% improvement was statistically significant and clinically meaningful (p<0.001)
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.