Amgen (Nasdaq: AMGN) held its Q2 2026 earnings call on August 4, 2026, with the most consequential pipeline disclosures centered on three developments: the discontinuation of AMG 513 in obesity, new detail on MariTide's extended-dosing ambitions, and a near-term binary readout for dazodalibep in Sjögren's disease. The call also provided the clearest public articulation to date of how Amgen intends to differentiate olpasiran from a competitor lipoprotein(a) program ahead of an imminent rival readout.
Total revenues reached USD 10.1 billion for the quarter, a 10% increase year-on-year, and Amgen raised full-year 2026 revenue guidance to a range of USD 38.2 billion to USD 39.4 billion.
AMG 513 Discontinued; MariTide Extended-Dosing Strategy Disclosed
Amgen's EVP of Research and Development James Bradner confirmed that AMG 513, a Phase I obesity asset, has been stopped. Bradner stated that "the bar is high at Amgen for obesity medicines," signaling that internally developed cardiometabolic candidates must clear a differentiation threshold before advancing — a standard AMG 513 did not meet.
More substantively, Bradner disclosed the strategic logic underpinning MariTide's Phase III design in greater detail than previously provided. The program now encompasses 9 ongoing and 3 additional planned Phase III studies across obesity, type 2 diabetes, heart failure, and atherosclerotic cardiovascular disease (ASCVD). Two distinct Phase III strategies were described:
Start and stay: MariTide's dose escalation is designed to reach target dose within two months, followed by monthly maintenance dosing with the option to transition to as few as 4 or 6 doses per year in dedicated maintenance extension studies.
Switch and stay: A dedicated Phase III study will evaluate switching patients from weekly GLP-1-based therapies to MariTide, with the goal of transitioning them to monthly dosing and potentially as few as four or six maintenance doses per year. Bradner attributed MariTide's suitability for extended dosing to its antibody-peptide conjugate design, in which GLP-1 agonist peptides are appended to an antibody backbone with an approximately 21-day half-life, with the appended peptides engineered for stability against tissue proteinases, serum esterases and other metabolic enzymes.
Bradner did not provide a timeline for any Phase III readout, describing 2026 as "a year of very disciplined data generation." MariTide competes in an obesity market currently dominated by weekly injectable GLP-1 receptor agonists; Amgen's stated differentiation rests on the less-frequent dosing schedule rather than weight-loss magnitude claims.
Olpasiran Positioned Ahead of Pelacarsen Readout
Bradner provided an unusually detailed update on the articulation of the OCEAN(a) trial design for olpasiran, an siRNA targeting lipoprotein(a) (Lp(a)), in the context of analyst questions about an imminent readout from Novartis/Ionis's antisense oligonucleotide pelacarsen in the HORIZON trial.
OCEAN(a)-Outcomes has enrolled 7,297 patients with Lp(a) ≥200 nmol/L — a higher threshold than HORIZON — in a double-blind, randomized, event-driven outcomes trial with a primary endpoint of 3-point major adverse cardiovascular events (MACE). Bradner said the decision to exclude ischemic stroke from the primary endpoint was based on human genetics and population science indicating that the association between Lp(a) elevation and ischemic stroke "was not as compelling as other cardiac-specific cardiovascular endpoints," and that this exclusion does not meaningfully affect the event rate by Amgen's modeling.
Management said they expect olpasiran's approximately 95% Lp(a) reduction and quarterly dosing to be differentiated from pelacarsen's approximately 70% reduction, and characterized the pelacarsen data as likely to provide "directional insight, but not decisional perspective" for OCEAN(a).
Dazodalibep Phase III Readout Expected H2 2026
Bradner and Murdo Gordon, EVP of Global Markets and Policy, provided updated enrollment figures and endpoint rationale for dazodalibep, a CD40 ligand Fc chimeric protein being evaluated in Sjögren's disease. The systemic disease study has enrolled 621 patients and uses the ESSDAI physician-observed score as its single primary endpoint. The symptomatic disease study has enrolled 434 patients and evaluates two patient-reported symptom measures at week 48, including ESSPRI and a diary-based symptom assessment. Results from both studies are expected in H2 2026.
Bradner said the dual patient-reported endpoint approach reflected interactions with regulators and clinical trial experts, as well as Amgen’s internal guidance. The Phase II data that supported advancement showed ESSDAI improvements of 6.3 versus 4.1 on placebo in the systemic population and ESSPRI improvements of −1.8 versus −0.5 on placebo in the symptomatic population. Gordon described Sjögren's disease as affecting more than 350,000 patients with few effective approved therapies.
Other pipeline updates:
Tarlatamab: In response to an analyst question about administration burden, Bradner disclosed that real-world and ongoing clinical study experience with Imdelltra (tarlatamab) has reduced monitoring requirements from 16 hours at the time of the pivotal Phase III approval to as low as 1 to 2 hours in some current studies. Bradner attributed this to the infrequency of immune effector cell-associated neurotoxicity syndrome (ICANS), which was predominantly observed at the 100 mg dose. He said this "opens the door towards sequential reductions in monitoring through prospective clinical investigation" and ongoing engagement with global regulators. The DeLLphi-315 Phase III study evaluating subcutaneous tarlatamab is underway, alongside three Phase III studies in earlier lines of small cell lung cancer (SCLC).
Sunakiment: Bradner confirmed that sunakiment (previously AMG 104), an inhaled anti-TSLP (thymic stromal lymphopoietin) antigen-binding fragment, or Fab, did not meet its primary endpoint of statistically significant reduction in composite asthma exacerbation events (CompEx) at 12 weeks in the Phase II LEVANTE dose-ranging study. Despite the miss, Amgen said it is planning a Phase III program with AstraZeneca, citing the "overall profile" of the molecule. No further detail on what supported that decision was provided on the call.
Forward-Looking Catalysts
- Dazodalibep H2 2026 readout: Phase III results in both systemic and symptomatic Sjögren's disease represent the first pivotal data for a CD40 ligand-targeting agent in this indication, and the first major binary event in Amgen's rare disease pipeline this year.
- OCEAN(a)-Outcomes event-driven readout: No timeline was given, but with 7,297 patients enrolled, the olpasiran outcomes trial is the largest cardiovascular program in Amgen's pipeline and its most significant long-term growth catalyst in the Lp(a) space.
- Imdelltra first-line SCLC data: Three Phase III studies in earlier-stage SCLC are underway; a positive result in first-line extensive-stage disease would expand the addressable population from the current second-line setting to as many as 28,000 patients in the US, management said.
Access the AllSci platform to explore the science behind the news.
Spot something wrong? Report an issue with this article