Biotech Values

[DewDiligence]

Bayer reports full phase-3 dataset_for FXIa inhibitor_in secondary-stroke-prevention:

https://www.businesswire.com/news/home/20260205888712/en/Bayers-Asundexian-Demonstrated-a-Substantial-26-Reduction-in-Stroke-After-a-Non-Cardioembolic-Ischemic-Stroke-or-High-Risk-Transient-Ischemic-Attack-With-No-Increase-in-ISTH-Major-Bleeding-Versus-Placebo

The cause-specific HR for the primary endpoint was 0.76, which is not hugely impressive; however, the trial was so large (12,327 patients) that the p-value was <0.0001. There was no meaningful increase in bleeding risk compared to placebo, which is the thesis behind FXIa (rather than FXa) inhibition.

Bayer announced that this trial was successful in Nov 2025 (#msg-176985075) but withheld the details until today.