MarketPulse

FDA Breakthrough Therapy Designation

3 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Oculis Holding Ag

Oculis to Present Pivotal Optic Neuritis Data as Privosegtor Advances Toward FDA Review

Oculis presents Phase 2 data for Privosegtor, an FDA Breakthrough-designated optic neuritis therapy showing improved visual acuity and reduced nerve damage, advancing toward Phase 3 registration trial.
OCSOCSAWFDA Breakthrough Therapy DesignationPrivosegtor
BenzingaBenzinga··Prnewswire

Psychedelic Drug Developers Entering Final Testing Phase for Mental Health Treatments

Five biotech firms advance psychedelic therapies to Phase 3 trials for depression and anxiety, with multiple readouts expected in 2026, marking progress toward regulatory approval.
ATAIDFTXGHRSLBRXpsychedelic biotechnologyPhase 3 trials
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Relay Therapeutics to Report 2025 Results Ahead of Phase 3 Pipeline Milestones

Relay Therapeutics reports 2025 results February 26, highlighting progress on lead drug zovegalisib advancing through Phase 3 trials with FDA Breakthrough Therapy Designation.
RLAYPhase 3 clinical trialFDA Breakthrough Therapy Designation