FDA Updates Sotatercept Label with HYPERION Data in Early PAH

The FDA has updated the sotatercept (WINREVAIR) label to include phase 3 HYPERION trial data showing significant efficacy in adults with pulmonary arterial hypertension (PAH) diagnosed within the last year, supporting its use earlier in the disease course alongside background therapy. The update coincides with European Respiratory Society guidelines incorporating sotatercept with a strong recommendation for PAH patients not achieving low-risk status on background therapy.

This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 22 Sep 2026 and 23 Sep 2026.