ProKidney posts FY2024 net loss of $163.3M; FDA confirms accelerated approval path for rilparencel

PROKIDNEY CORP.

Net loss before noncontrolling interest $163.3M in 2024 vs $135.4M in 2023; R&D expenses rose 20% to $127.7M.
Cash and equivalents $358.3M at year-end; secured $140M equity to fund operations into mid-2027.
FDA confirmed accelerated approval pathway for rilparencel using eGFR slope as potential surrogate endpoint; PROACT 2 discontinued.
Full Phase 2 REGEN-007 Group 1 data expected Q2 2025; interim June 2024 showed 18-month kidney function stabilization.
Phase 3 PROACT 1 single study may support BLA; additional FDA meeting details expected mid-2025.

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