BMS-986495 / Prothena, BMS - LARVOL DELTA

Prothena Reports Fourth Quarter and Full Year 2024 Financial Results, and Provides Financial Guidance and Business Highlights (Businesswire) - "PRX019: Phase 1 clinical trial expected to complete in 2026. Birtamimab: The ongoing confirmatory Phase 3 AFFIRM-AL clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA with a primary endpoint of all-cause mortality (time-to-event) at a statistical significance level of 0.10. Topline results from confirmatory Phase 3 AFFIRM-AL clinical trial expected in 2Q 2025. Coramitug: Phase 2 clinical trial has completed enrollment of approximately 99 patients with trial completion expected in 1H 2025."

P3 data: top line • Trial completion date • Amyloidosis • Cardiomyopathy • CNS Disorders

Phase 1 Study of PRX019 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Prothena Biosciences Ltd.

New P1 trial

Prothena Announces Bristol Myers Squibb Opt-in for Exclusive Global License for PRX019, the Second Program from Global Neuroscience Research and Development Collaboration (Businesswire) - "Prothena Corporation plc...announced that Bristol Myers Squibb obtained the exclusive global license for PRX019 and will pay Prothena $80 million....Prothena plans to initiate the Phase 1 clinical trial for PRX019 by year-end 2024....As part of the PRX019 global license with Bristol Myers Squibb, Prothena will be eligible to receive additional development, regulatory, and sales milestone payments of up to $617.5 million. Prothena also will be eligible to receive tiered royalties on net sales."

Licensing / partnership • New P1 trial • CNS Disorders

Prothena Reports First Quarter 2024 Financial Results and Business Highlights (Businesswire) - "Topline results from Phase 2b PADOVA clinical trial in patients with early Parkinson’s disease, which has completed enrollment, expected in 2H 2024 (NCT04777331)...PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target...Phase 1 clinical trial timeline update expected in 2024..."

Enrollment closed • New P1 trial • P2b data • CNS Disorders • Parkinson's Disease