Amgen Inc. (NASDAQ:AMGN) shares are down on Monday after the company announced topline results from a Phase 3 trial of TEPEZZA, which is administered via an on-body injector for patients with moderate-to-severe active Thyroid Eye Disease.

Trial Meets Primary Endpoint

The Phase 3 TEPEZZA OBI trial met its primary endpoint, showing a statistically significant 77% proptosis (bulging eyes) response rate among participants during the 24-week placebo-controlled period.

The study demonstrated a mean proptosis reduction of -3.17 mm.

Last week, the U.S. Food and Drug Administration (FDA) warned about serious and sometimes fatal liver injuries tied to Amgen’s Tavneos (avacopan)

The agency cited postmarketing data that point to new safety concerns beyond those identified in clinical trials.

Tavneos, approved in October 2021, is used ...