With the first Phase 3 data expected for Amgen’s MariTide next year, analysts are looking for evidence that the GLP-1 candidate is tolerable. Meanwhile, the company has begun testing an autoinjector formulation.
Amgen is racing toward readouts for its GLP-1 program, reaffirming plans for the candidate in its third quarter earnings report and beginning a study to support launching the product as an autoinjector.
The injectable drug candidate, MariTide, is differentiated on paper from incumbent GLP-1 products sold by Eli Lilly and Novo, notably by a half-life that Amgen believes can support dosing as infrequently as four times per year. In practice, however, “MariTide differentiation [is] still more of a show-me story,” BMO Capital Markets analysts said in a Nov. 3 note to investors.
“Management emphasized monthly dosing, potentially extending to four or six annual doses, and described gastrointestinal symptoms as generally short-lived despite prolonged pharmacologic activity,” BMO analysts said. “These observations are encouraging, but do not substitute for Phase 3 tolerability data.”
Amgen is expected to publish the first Phase 3 MariTide data next year. Ahead of the readouts, tolerability and maintenance, not weight loss, are driving the debate, Truist Securities analysts said in a Nov. 3 note, writing that they see “dose-escalation tolerability, durability and maintenance as key to validating differentiation.”
With pivotal data approaching, Amgen recently began another Phase 3 trial to study the home-based self-administration of subcutaneous MariTide using an autoinjector. The study has a primary completion date in June 2027, per ClinicalTrials.gov, leading TD Cowen analysts to predict in a Nov. 3 note that the trial could enable Amgen to launch MariTide as an autoinjector.
Amgen has been “pretty consistent in sharing that MariTide is expected ultimately to be delivered in a patient-friendly single-chamber handheld autoinjector,” Jay Bradner, executive vice president of R&D at the company, said on the third quarter earnings call. Amgen has “significant experience” with the delivery devices and has “taken a fairly standard approach,” Bradner added.
CFO Thomas Dittrich reaffirmed that Amgen expects capital expenditures of about $2.6 billion this year to scale manufacturing capacity for commercial growth and to prepare for a potential MariTide launch. Asked by an analyst whether biosimilar production capacity could support MariTide, CEO Robert Bradway said Amgen considers all options but feels confident it can continue to be a reliable biosimilar supplier.
A series of readouts will determine how much manufacturing capacity Amgen needs for MariTide. The biotech’s Phase 3 MARITIME program features 10 trials, and two more studies are scheduled to start this year. Amgen recently completed enrollment in two Phase 3 sleep apnea studies and a cardiovascular outcome trial, according to the earnings release.
Beyond MariTide, Amgen’s schedule for 2026 includes the completion of a Phase 3 dazodalibep study in symptomatic Sjogren’s disease. A Phase 3 trial of the CD40L antagonist in systemic Sjogren’s met its primary endpoint in September, but it is hard to read through from the successful trial to the ongoing study because the patient populations are different, Bradner said.
Amgen provided the pipeline updates as part of third quarter earnings in which revenues increased 8% to $10.4 billion. Key Amgen brands, including Repatha, Uplizna, Evenity, Blincyto and Imdelltra, continue to outperform, William Blair analysts said in a Nov. 4 note.
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