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Biotech Stocks Facing FDA Decision In October 2025

Amgen
Amgen

The FDA is expected to deliver its decision on the expanded use of Tezspire for treating chronic rhinosinusitis with nasal polyps by October 19, 2025.

In a phase III trial, dubbed WAYPOINT, Tezspire significantly reduced nasal congestion, polyp size, and nearly eliminated the need for surgery in patients with chronic rhinosinusitis with nasal polyps.

Co-developed by AstraZeneca plc (AZN) and Amgen Inc. (AMGN), Tezspire is already approved for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. The combined sales of Tezspire, recorded by Amgen and AstraZeneca, rose to $826 million in the first half of 2025, from $507 million in the first half of 2024.

AMGN closed Friday’s (September 26, 2025) trading at $272.98, up 0.66%.