ProKidney reports statistically significant Phase 2 REGEN-007 results for rilparencel; FDA Type B meeting set

PROKIDNEY CORP.

eGFR slope improved 78% from -5.8 to -1.3 mL/min/1.73m² per year (p<0.001) in Group 1 (n=24).
Group 2 showed 50% improvement but not statistically significant (p=0.085); evidence of dose response.
No rilparencel-related serious adverse events observed; safety consistent with prior studies and kidney biopsy.
FDA Type B meeting set for summer 2025 to confirm eGFR slope as surrogate endpoint for accelerated approval.
Full results submitted to ASN 2025 Kidney Week as late-breaking clinical trial.

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