The FDA approved Bayer’s asundexian (Sunharbo), the first drug in a new cardiovascular medicines class focused on reducing the risk of stroke. The once-daily pill is indicated for secondary stroke prevention in adults. For biotech and pharma companies monitoring anticoagulation innovation, the approval underscores continued regulatory appetite for targeted mechanisms in secondary prevention—especially for agents designed to reduce stroke risk without the same profile historically associated with broader anticoagulant strategies. The near-term commercial and competitive implications will hinge on real-world uptake and how clinicians position asundexian versus existing standards of care in stroke risk management.