Pins matching company:Amgen

On 1 June 1989 the FDA approved Epogen (epoetin alfa), Amgen's recombinant erythropoietin for anemia in kidney dialysis patients, its first product after nine years in business.

On 6 October 2023 Amgen completed its acquisition of Horizon Therapeutics for US$116.50 per share in cash, a transaction equity value of about US$27.8 billion that added Tepezza, Krystexxa and Uplizna.

On 26 November 2024 Amgen reported 52-week Phase 2 data for its monthly obesity candidate MariTide, with up to about 20% average weight loss without a plateau, and announced the MARITIME Phase 3 program.

On 27 April 2026 the FDA's drug centre issued a proposal to withdraw approval of Amgen's Tavneos for ANCA-associated vasculitis, alleging lack of substantial evidence of effectiveness; Amgen disagrees and the drug stays on the market.

On 4 August 2026 Amgen reported second-quarter revenue up 10% to US$10.1 billion, with GAAP EPS of US$4.37 and non-GAAP EPS of US$6.29, as 22 products grew at double-digit rates.

Amgen's phase 3 trial of Maridebart Cafraglutide in obesity reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 3,200 participants. The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Amgen's phase 3 trial of Maridebart Cafraglutide in atherosclerotic cardiovascular disease reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 12,800 participants. The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.

Amgen's phase 3 trial of Maridebart Cafraglutide in heart failure with preserved ejection fraction reaches primary completion, the point at which the last participant's primary outcome is measured. The trial enrolled 5,056 participants. This trial will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part trial with a double-blind period and an open-label extension (OLE). The trial is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.