Amgen updates MariTide pipeline, discontinues AMG 513, keeps pressing FDA on TAVNEOS
Amgen widened its MariTide Phase 3 program, dropped AMG 513, and continued its fight with the FDA over pulling TAVNEOS, while reporting second-quarter results.
Amgen disclosed that future development of AMG 513 will be discontinued, though a Phase 1 study of the molecule in adults living with obesity will remain ongoing to follow enrolled participants through completion of the study.1
The company's obesity franchise now centers on an expanded MariTide (maridebart cafraglutide/AMG 133) program. Beyond the core MARITIME-1 and MARITIME-2 weight management studies, Amgen is running MARITIME-CV, a Phase 3 study of MariTide on cardiovascular outcomes, enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight1, and MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity1. Two sleep apnea trials are enrolling as well, one in patients on positive airway pressure therapy and one in patients not on that therapy. Amgen said three Phase 3 studies of MariTide in people living with Type 2 diabetes will be initiated in 2026.1
On regulatory matters, Amgen said it continues to engage the FDA regarding the Center for Drug Evaluation and Research's request to voluntarily withdraw TAVNEOS from the U.S. market, having requested a hearing on June 1, 2026 and submitted supporting materials on July 23, 2026, which the company believes support a favorable benefit-risk profile of TAVNEOS for patients with AAV.1 Separately, two subcutaneous blinatumomab studies, in adults and adolescents and in pediatric patients, have paused enrollment following a partial clinical hold by the FDA, with discussions underway on a path to reopen both.1
On finances, Amgen reported cash and cash equivalents of $14.0 billion and debt outstanding of $57.3 billion as of June 30, 20261, with free cash flow of $3.5 billion for the quarter, versus $1.9 billion a year earlier1. The company guided full-year 2026 total revenues in the range of $38.2 billion to $39.4 billion.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.