ProKidney reports Q3 EPS (14c), consensus (15c)
The Fly

ProKidney reports Q3 EPS (14c), consensus (15c)

“Following a successful FDA Type B meeting, we are pleased to announce that the FDA agrees that the Phase 3 PROACT 1 study could be sufficient to support a potential BLA submission and full regulatory approval, validating our recent decision to focus on expediting PROACT 1,” stated Bruce Culleton, M.D., Chief Executive Officer. “Notably, the FDA also confirmed that ProKidney (PROK) could consider using eGFR slope as a surrogate endpoint on an accelerated approval pathway for rilparencel. We look forward to continuing our dialogue with the FDA, under RMAT designation, to accelerate rilparencel’s path to market and address the high unmet need in patients with advanced CKD and diabetes.”

Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App