MarketPulse

FDA Breakthrough Therapy Designation

5 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Ataibeckley Inc.

AtaiBeckley CEO to Present at Needham Conferences as Psychedelic Drug Advances

AtaiBeckley will showcase its FDA-designated breakthrough therapy BPL-003 at Needham conferences in April, advancing toward Phase 3 trials in 2026.
ATAItreatment-resistant depressionFDA Breakthrough Therapy Designation
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Biogen's Lupus Drug Shows Promise Again, Edges Closer to Historic FDA Approval

Biogen announces second positive Phase 2 trial of litifilimab for cutaneous lupus, showing 11.8% greater disease reduction than placebo, advancing toward potential first targeted CLE therapy in 70 years.
BIIBFDA Breakthrough Therapy Designationclinical trial results
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