Bristol Myers Squibb has delayed key late-stage readouts for two high-profile assets:
Cobenfy (xanomeline/trospium) in Alzheimer’s disease psychosis and milvexian, an oral Factor XIa inhibitor partnered with Johnson & Johnson, to 2027.
The Cobenfy ADEPT program, which includes Phase 3 trials ADEPT‑1, ‑2, and ‑4 in Alzheimer’s disease psychosis, is now expected to produce top‑line results beginning in early 2027, with readouts spread across the year; an interim analysis for ADEPT‑1 may come later in 2026.
The milvexian atrial fibrillation study, which is event‑driven, is now slated for a readout in the first quarter of 2027 rather than late 2026, reflecting slower-than‑expected event accrual despite the study remaining on track safety‑wise.
The delays stem from slower enrollment and slower relapse event accrual for Cobenfy’s ADEPT trials and slower event accrual for milvexian’s atrial fibrillation trial; both programs still have strong internal confidence and remain central to BMS’s near‑term growth narrative.
Despite these timing slippages, the company raised its 2026 financial guidance due to strong Eliquis performance and a robust late‑stage pipeline, underscoring that the Cobenfy and milvexian delays are seen as timing issues rather than fundamental derisks.
Sources:
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