BMS-986446 receives FDA fast track designation for alzheimer's treatment

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Prothena’s Partner Bristol Myers Squibb Obtains Fast Track Designation from the U.S. FDA for BMS-986446 (PRX005), an Anti-MTBR-Tau-Targeting Antibody, for the Treatment of Alzheimer’s Disease

October 1, 2025 4:45 PM EDT

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease Fast Track Designation recognizes the potential of anti-MTBR tau to be an important treatment option for patients with Alzheimers disease

DUBLIN--(BUSINESS WIRE)-- Prothena Corporation plc (NASDAQ: PRTA), announced today that Bristol Myers Squibb communicated in a press release that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody currently in Phase 2 development... More