Milvexian for atrial fibrillation (LIBREXIA-AF)

Resolution Criteria Trial: NCT05757869 Selected endpoint key: 2aa01f770e67e95fd9ea549e11475c76f94f103903b88d2b0eeb53397d24d36c Selected endpoint: Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism Endpoint type: composite Protocol outcome group: primary Endpoint description: Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported. Endpoint timeframe: Up to 4 years ClinicalTrials.gov population: Participants with atrial fibrillation Market population: Participants with atrial fibrillation Analysis set: Not specified in the enumerated protocol outcome Comparison: Milvexian versus apixaban Success direction: non_inferiority Success rule: For participants with atrial fibrillation, milvexian must meet the prespecified statistical non-inferiority success criterion versus apixaban for time to the first occurrence of the composite endpoint of stroke and non-CNS systemic embolism, assessed up to 4 years. The enumerated protocol outcome does not specify a numerical non-inferiority margin or analysis set, so none is inferred. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT05757869?tab=researcher#outcome-measures:~:text=Time%20to%20the%20First%20Occurrence%20of%20Composite%20Endpoint%20of%20Stroke%20and%20Non-central%20nervous%20system%20(CNS)%20Systemic%20Embolism YES 1. The exact selected endpoint (Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2027-12-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2027-12-31T23:59:59Z Deadline evidence: AI bounded approximation (confidence 95/100): official source supports 2027-01-01 through 2027-12-31; market deadline 2027-12-31 is the conservative end of that window. Bristol Myers Squibb's official Q2 2026 results presentation, dated July 30, 2026 and filed on SEC.gov, lists Milvexian AF (LIBREXIA-AF), a trial conducted by Johnson & Johnson, under NME registrational data expected in 2027. Because the official evidence supports only the calendar year rather than an exact day, the conservative market deadline is the final calendar day of that window. This market-disclosure window supersedes use of the ClinicalTrials.gov completion date as a fabricated readout date. Deadline evidence source: https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/q22026earningspresentati.htm Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.