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Amgen

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Amgen shifts focus to MariTide as AMG 513 is scrapped
business21 days ago

Amgen shifts focus to MariTide as AMG 513 is scrapped

Amgen ended development of its phase 1 obesity drug AMG 513, while continuing the trial for patients already enrolled, and pivoted its obesity strategy to MariTide, a phase 3 antibody–peptide conjugate intended to activate the GLP-1 receptor and inhibit GIPR with a likely four to six doses per year. The company previously faced an FDA hold on AMG 513 and also scrapped AMG 786; MariTide now anchors Amgen’s near‑term obesity program, with weight‑loss readouts expected next year alongside broader studies of cardiovascular risk, type 2 diabetes and sleep apnea. Preclinical obesity assets and other mechanisms remain under exploration.

via Fierce Biotech|
#amgen#business#gipr
FDA tests real-time clinical-trial reviews to speed approvals
technology3 months ago

FDA tests real-time clinical-trial reviews to speed approvals

The FDA announced a pilot to let reviewers access safety and efficacy signals from ongoing clinical trials in real time via a cloud platform, with AstraZeneca and Amgen participating, aiming to cut development time and speed regulatory decisions without replacing traditional sponsor meetings. A parallel AI pilot to optimize early trials is planned, and public comments are invited, all while safeguarding patient privacy.

via Fierce Biotech|
#ai#amgen#astrazeneca
Amgen keeps Tavneos on market as regulators review trial data and safety
business6 months ago

Amgen keeps Tavneos on market as regulators review trial data and safety

Amgen says it will not voluntarily withdraw Tavneos after an FDA request and will continue talks with regulators, even as the EMA re-examines Tavneos data integrity. The FDA is reviewing the original ChemoCentryx trial data and the drug’s risk-benefit profile due to rare hepatotoxicity, while Amgen asserts the underlying data are sound. Tavneos, approved in 2021 in the US and 2022 in the EU, remains a small but growing part of Amgen’s portfolio as it pursues milestones for other drugs like Uplizna and guides 2026 revenue higher after a 2025 showing of about $36.7B.

via Fierce Pharma|
#amgen#business#data-integrity
Amgen's Obesity Drug Shows Mixed Results, Stock Reacts
business1 year ago

Amgen's Obesity Drug Shows Mixed Results, Stock Reacts

Amgen Inc.'s shares plummeted by 12%, marking the largest drop in 23 years, after its experimental obesity drug, MariTide, failed to significantly outperform competitors and showed a high rate of gastrointestinal side effects. The drug achieved a 20% weight loss in a yearlong trial, falling short of the 25% target set by rivals Eli Lilly and Novo Nordisk. The study also reported a 40% vomiting rate, leading to an 11% discontinuation rate. Amgen plans to test a lower initial dose to reduce side effects in future studies.

via Yahoo Finance|
#amgen#business#obesity
Amgen Shares Fall Despite Promising Obesity Drug Results
business1 year ago

Amgen Shares Fall Despite Promising Obesity Drug Results

Amgen's stock plummeted 12% after its obesity drug, MariTide, showed comparable results to Eli Lilly's Zepbound in weight loss efficacy but had a higher dropout rate due to side effects. While patients lost about 20% of their body weight with less frequent dosing, 11% discontinued due to gastrointestinal issues, compared to 7% for Zepbound. The market reacted negatively despite the drug meeting expectations, highlighting the competitive nature of the weight-loss drug market.

via Investor's Business Daily|
#amgen#business#clinical-trials