Cadrenal Therapeutics received FDA guidance for a pivotal Phase 3 trial of CAD-1005 in HIT after an End-of-Phase 2 meeting. Phase 2 data showed a >25% absolute reduction in thrombotic events. The company also plans a Phase 2a trial in cardiac surgery-associated AKI.
The phase 3 OCEANIC-STROKE trial of 12,327 patients showed asundexian, an oral Factor XIa inhibitor, reduced ischemic stroke recurrence by 26% when added to standard antiplatelet therapy, with no increase in major bleeding events.
The global biopharmaceutical industry entered 2026 facing one of the largest waves of patent expirations in its history, with $200-300 billion in yearly sales at risk through 2032 as major drugs lose exclusivity.