BMY’s BMS-986446 Gains Fast Track, Phase II Trial Enrolling 310 Patients
Bristol Myers Squibb’s anti-tau antibody BMS-986446 received FDA Fast Track designation and is enrolling approximately 310 early Alzheimer’s patients in its phase II TargetTau-1 study, with primary completion expected in 2027. BMY is also advancing PRX019 through a phase I safety and pharmacokinetics trial with topline results due in 2026.
1. FDA Fast Track Designation and Phase II Enrollment
Bristol Myers Squibb’s anti-tau antibody BMS-986446 obtained FDA Fast Track status and has begun enrolling approximately 310 patients in the phase II TargetTau-1 trial for early Alzheimer’s disease. The study’s primary completion is slated for 2027, marking the first late-stage readout in BMY’s neurodegenerative pipeline.
2. Phase I PRX019 Trial Progress
BMY is collaborating on PRX019, an early-stage neurodegenerative candidate, now in a phase I open-label trial assessing safety, tolerability, immunogenicity and pharmacokinetics in healthy volunteers. Topline results from this trial are expected by 2026 and will inform dose selection for subsequent studies.
3. Pipeline Implications and Next Catalysts
Upcoming data readouts from both the TargetTau-1 phase II study and PRX019 phase I trial represent key catalysts for BMY’s neuroscience franchise. Positive outcomes could strengthen the company’s late-stage pipeline and provide clarity on potential regulatory filings and commercialization timelines.