Prothena's Phase 3 AFFIRM-AL trial for birtamimab fails; development halted; workforce reduction planned

PROTHENA CORP PUBLIC LTD CO

Phase 3 AFFIRM-AL did not meet primary endpoint of all-cause mortality (HR=0.915, p=0.7680); secondary endpoints also missed.
Birtamimab development discontinued; open-label extension stopped.
Company to substantially reduce workforce and operating expenses; further update expected in June 2025.
Birtamimab was generally safe and well-tolerated, consistent with prior safety profile.
Upcoming data: PRX012 Phase 1 ASCENT (Alzheimer's) in August; partner updates from Roche, Novo Nordisk, BMS in 2025-2026.

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