FDA Confirms Deaths Linked to Amgen's Tavneos; New Lung Cancer Trial Initiated

The U.S. Food and Drug Administration (FDA) has intensified its safety warnings for Amgen's drug Tavneos, reporting dozens of severe liver injury cases and confirmed deaths. The regulator specifically highlighted vanishing bile duct syndrome as a critical risk, adding significant pressure to the biotechnology giant which is already grappling with declining operating margins. In a strategic move to bolster its pipeline amid these setbacks, Amgen has initiated a Phase 1b clinical trial in collaboration with Zai Lab for lung cancer oncology programs. This expansion into oncology comes at a time when investor sentiment is already cautious due to recent reports of insider selling. While the new collaboration offers a potential growth catalyst, the severity of the Tavneos safety data remains a primary concern for the company's commercial outlook. Market participants are closely monitoring the impact on AMGN stock as the company navigates these heightened regulatory risks and clinical developments.