MarketPulse

FDA accelerated approval

3 articles
The Motley FoolThe Motley Fool··James Brumley

Agios Pharma Soars 21% on FDA Fast-Track Win for Sickle Cell Drug

Agios Pharmaceuticals surges on FDA accelerated approval for mitapivat sickle cell treatment, enabling faster path to full approval despite company's ongoing losses.
AGIObiotechpharmaceutical
GlobeNewswire Inc.GlobeNewswire Inc.··Prokidney Corp.

ProKidney Secures $270M Cash Position, Eyes Mid-2027 Approval for Kidney Disease Treatment

ProKidney reports $270M cash reserves extending operations to mid-2027, achieves FDA alignment on accelerated approval pathway for rilparencel with Phase 3 enrollment progressing ahead of schedule.
PROKclinical trialchronic kidney disease
GlobeNewswire Inc.GlobeNewswire Inc.··Levi & Korsinsky, Llp

Inovio Hit With Securities Lawsuit Over FDA Approval Claims

Levi & Korsinsky files class action against Inovio Pharmaceuticals alleging management misrepresented FDA accelerated approval eligibility for lead candidate, causing stock decline.
INOsecurities class actionBiologics License Application