Amgen said Tuesday that the Food and Drug Administration has ordered a hold on a study of the company’s early-stage obesity candidate, another potential setback in the company’s efforts to join the booming weight loss drug market.
Amgen has so far said little about the drug, dubbed AMG 513, and has not described the drug’s mechanism. On a call with analysts, Amgen executives did not explain why AMG 513 is on a clinical hold, other than to say “it’s not related to the drug” and that discussions are underway to reopen the study.
There’s been more attention around the company’s later-stage candidate, MariTide, a monthly injectable that investors hoped could compete against drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. But the company late last year reported that MariTide produced about 20% weight loss in patients enrolled in a Phase 2 trial — results that fell short of investors’ expectations.
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