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Bayer’s Asundexian Cuts Recurrent Stroke by 26% in Phase III Without Added Major Bleeding

Regulatory filings now follow, with sales prospects tied to how competitors fare.

Overview

  • Asundexian reduced recurrent strokes by about 26% versus placebo in more than 12,000 patients with prior non‑cardioembolic ischemic stroke or high‑risk TIA, given once daily on top of antiplatelet therapy.
  • No increase in major ISTH bleeding was observed compared with placebo, and rates of other bleeding outcomes were similar between groups.
  • Detailed results were presented at a medical conference in New Orleans, refining earlier positive signals from the Oceanic‑Stroke program.
  • Bayer intends to submit the data to health authorities and already holds U.S. Fast‑Track status for certain stroke patients.
  • Analysts peg potential peak sales in the €1–2 billion range in a roughly €3 billion market, though final uptake will hinge on rival data such as Milvexian results expected in late 2026 to early 2027.