FDA approves Bayer's Sunharbo (asundexian) for secondary stroke prevention

This is a genuine, forward-looking regulatory event rather than price commentary: the supplied Reuters report and FDA material explicitly state that the FDA approved Sunharbo (asundexian) for a defined secondary-stroke-prevention population. The first approved Factor XIa inhibitor creates direct U.S. commercialization and competitive implications for Bayer, while the 26% OCEANIC-STROKE result supports high materiality. Importance is moderated because the approved indication is limited and the decision followed positive Phase 3 data, Fast Track/Priority Review, and a pending application, so the approval was informative but not an extreme surprise. The action date is clearly November 9, 2026, but no exact FDA decision time is provided; the timestamp is therefore a UTC date-level estimate at 00:00 with reduced timestamp confidence. BAYN.DE is the direct stakeholder. BMY and JNJ are also approved because the supplied context explicitly identifies their milvexian program as a potential competing Factor XIa therapy; other pipeline and manufacturing names are excluded because their effects are indirect, speculative, or not product-specific. The development is approved and treated as a new regulatory-approval event distinct from the cited China authorization.