MarketPulse

Breakthrough Therapy Designation

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

Oculis Secures FDA Approval for Optic Neuritis Trial Design, Clearing Path to Drug Submission

Oculis secures FDA agreement on Phase 3 trial design for Privosegtor optic neuritis treatment, de-risking regulatory pathway and clearing way for future drug submission.
OCSOCSAWFDA approvalPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Oculis Holding Ag

Oculis Clears FDA Hurdle for Optic Neuritis Drug in $7B Market

Oculis secures FDA Special Protocol Assessment for Privosegtor Phase 3 trial, de-risking path to potential $7 billion optic neuritis market.
OCSOCSAWFDA approvalPhase 3 trial
GlobeNewswire Inc.GlobeNewswire Inc.··Belite Bio, Inc

Belite Bio Pursues FDA Approval for Tinlarebant, Potential First Stargardt Disease Treatment

Belite Bio begins rolling NDA submission to FDA for tinlarebant, a potential breakthrough oral therapy for rare Stargardt disease, targeting 2027 commercialization.
BLTEFDA approvalrare disease
BenzingaBenzinga··Vandana Singh

Praxis Precision Surges on FDA Nod for Essential Tremor Treatment

Praxis Precision shares surge 7.15% after FDA accepts essential tremor drug application with January 2027 decision target and positive Phase 3 results.
PRAXFDA approvalbiotech
GlobeNewswire Inc.GlobeNewswire Inc.··Na

NRx Pharmaceuticals Appoints First Chief Commercial Officer Ahead of Ketamine FDA Approvals

NRx Pharmaceuticals names Glenn Tyson as inaugural Chief Commercial Officer, bolstering leadership ahead of anticipated FDA approvals for ketamine products.
NRXPNRXPWBreakthrough Therapy DesignationFast Track designation
GlobeNewswire Inc.GlobeNewswire Inc.··Vaxcyte, Inc.

Vaxcyte's 31-Valent Pneumococcal Vaccine Advances to Phase 3 on Strong Clinical Data

Vaxcyte publishes positive Phase 1/2 data for VAX-31, a 31-valent pneumococcal vaccine, and advances to Phase 3 trials with topline results expected Q4 2026.
PCVXPhase 3 clinical trialBreakthrough Therapy Designation
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Oculis Charts Bold 2026 Path With Pipeline Milestones at Investor Conferences

Oculis announces March 2026 investor conference participation, showcasing pipeline advances including Privosegtor's optic neuritis breakthrough designation and anticipated Phase 3 readouts.
OCSOCSAWinvestor conferencesclinical trials
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Oculis Eyes Clinical Inflection Point With Six Pivotal Readouts Ahead

Oculis plans March 2026 investor conferences highlighting six pivotal clinical readouts, including Privosegtor's breakthrough optic neuritis program and OCS-01 Phase 3 results expected Q2 2026.
OCSOCSAWinvestor conferencesclinical trials
BenzingaBenzinga··Vandana Singh

Bristol Myers' Experimental Breast Cancer Treatment Demonstrates Survival Gains in Advanced Patients

Bristol Myers Squibb's experimental breast cancer drug showed survival improvements in advanced patients, though stock declined slightly following the announcement.
BMYCELGrbreast cancerPhase 3 trial