Amgen Inc. (AMGN), a commercial-stage biotechnology firm, on Monday announced positive topline results from a Phase 3 trial of TEPEZZA (teprotumumab-trbw) administered by subcutaneous injection via an on-body injector (OBI in participants with moderate-to-severe active Thyroid Eye Disease (TED).
The phase 3 trial of TEPEZZA is a randomised, double-masked, placebo-controlled, parallel-group, multicentre trial evaluating the efficacy and safety of subcutaneous TEPEZZA administered via an on-body injector (OBI) vs placebo in patients with active TED.
The primary endpoint was proptosis responder rate, the percentage of participants with a =2-mm reduction from baseline in proptosis in the study eye without deterioration (=2-mm increase) of proptosis in the fellow eye at Week 24.
The Phase 3 TEPEZZA OBI trial met its primary endpoint in moderate-to-severe active TED, demonstrating a statistically significant and clinically meaningful 77% proptosis response rate during the 24-week placebo-controlled period, compared with 19.6% with placebo.
Importantly, the mean proptosis reduction, a key secondary endpoint, was -3.17 mm, compared with -0.80 mm in the placebo group at week 24.
The overall safety results were generally consistent with TEPEZZA's known safety profile, according to the firm.
TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling.
TEPEZZA OBI works about as well as the IV version, which was approved in 2020 for TED, and builds on its success, the firm noted.
"These results extend and support the best-in-class efficacy of TEPEZZA for people living with Thyroid Eye Disease, now with subcutaneous administration delivering IV-level efficacy," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen.
AMGN has traded between $261.43 and $391.29 in the last year. The stock closed Thursday's trade at $347.94.
AMGN is currently trading at $344.33, down 1.04%.
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