Amgen's AMGN Q1 2026 earnings conference call, held April 30, 2026, was dominated by three pipeline signals: an expanding Phase III program for MariTide (maridebart cafraglutide) that now includes a switching study from weekly GLP-1 therapies, a regulatory confrontation over Tavneos (avacopan) following a US FDA proposal to withdraw its approval, and the discontinuation of AMG 193, Amgen's MTA-cooperative PRMT5 inhibitor.
Key Strategic Signals
MariTide: Amgen announced three new Phase III studies for MariTide, its antibody-peptide conjugate targeting GLP-1 and GIP receptors. Two are long-term extensions of ongoing chronic weight management trials, enrolling participants who completed 72 weeks of treatment in a parent study into a 48-week extension evaluating monthly, every-8-week, or quarterly dosing. The third, the SWITCH study, is a 300-patient trial evaluating transition from weekly injectable GLP-1 therapies — specifically semaglutide or tirzepatide — to MariTide on an every-8-week or quarterly schedule, with 52-week change in body weight as the primary endpoint. Executives said the study design reflects the commercial reality that many patients entering the obesity market will already be on weekly agents. Amgen also disclosed that 3-step dose escalation, studied in a Phase I physiology study conducted in preparation for potential regulatory filings, further reduced rates of nausea and vomiting compared to prior 2-step escalation experience. R&D chief James Bradner said the antibody backbone of MariTide produces stable, sustained drug exposure that avoids the peak-trough cycling of daily oral or weekly injectable agents, and that when GI side effects do occur, their duration appears short. Bradner acknowledged that efficacy and tolerability data from the pivotal Phase III studies remain outstanding.
Tavneos and the FDA withdrawal proposal: Amgen disclosed that the US FDA has proposed to withdraw the approval of Tavneos (avacopan) for anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis), a rare and life-threatening condition. Executives said the company contests the proposal and intends to engage further with the agency. Tavneos generated USD 119 million in first quarter 2026 sales, up 32% year-over-year. The transcript provided no detail on the scientific or regulatory basis for the FDA's proposed action. The absence of detail leaves uncertainty around whether the issue relates to confirmatory data, safety, or regulatory interpretation, with Amgen offering no timeline or resolution pathway.
AMG 193 discontinued: Following a comprehensive pipeline review, Amgen discontinued development of AMG 193, its MTA-cooperative PRMT5 inhibitor. No clinical data were cited as the basis for the decision. The discontinuation coincided with a stated 16% year-over-year increase in non-GAAP R&D spending, with management indicating investment is being concentrated on MariTide, Imdelltra (tarlatamab), and olpasiran. AMG 193 (anvumetostat) had reached the Phase II stage for cancers with homozygous MTAP deletion including NSCLC.
Analyst Pressure Points
MariTide tolerability and competitive positioning: Analysts from JPMorgan and Goldman Sachs pressed Bradner on the specifics of GI tolerability with 3-step dose escalation and on why the SWITCH study evaluates only every-8-week and quarterly dosing rather than monthly. Bradner said monthly MariTide is already well characterized across all enrolling Phase III programs and that the SWITCH study is specifically designed to explore the less-frequent dosing intervals most relevant to patients switching from weekly agents. He did not provide absolute rates of nausea or vomiting from the 3-step escalation experience, nor did he offer a direct numerical comparison to rates reported for Wegovy (semaglutide) or Zepbound (tirzepatide). When Scotiabank's Louise Chen asked directly whether Amgen was targeting a third-place market position behind Novo Nordisk and Eli Lilly, CEO Robert Bradway declined to characterize a market ambition, stating the company would wait for data before making such claims.
Subcutaneous blinatumomab enrollment pause: Analyst Matthew Phipps from William Blair asked about two developments disclosed in Amgen's first quarter 2026 press release: stopped enrollment in a blinatumomab systemic lupus erythematosus (SLE) trial, and a pause in subcutaneous blinatumomab enrollment in acute lymphoblastic leukemia (ALL) studies. Bradner confirmed that enrollment in subcutaneous Blincyto (blinatumomab) studies — including a potential registration-enabling Phase II in adults and adolescents with relapsed or refractory B-cell ALL and a Phase Ib/II in pediatric patients — has been paused following observation of inflammatory reactions. He said Amgen is collecting patient data and in dialogue with the US FDA, and expects to reopen enrollment shortly. He cited prior data showing 89% to 92% remission rates with subcutaneous blinatumomab in relapsed/refractory B-ALL as the basis for continued confidence in the program.
Forward-Looking Catalysts
H2 2026 — Dazodalibep Phase III Sjögren's disease readouts: Both Phase III studies of dazodalibep, Amgen's first-in-class CD40 ligand-targeting fusion protein, have completed enrollment and are expected to read out in the second half of 2026. One study evaluates patients with systemic Sjögren's disease using the European Sjögren's Syndrome Disease Activity Index (ESSDAI) as the primary endpoint; the other targets patients with moderate to high symptomatic disease using the European Sjögren's Syndrome Patient Reported Index (ESSPRI). Bradner positioned dazodalibep as mechanistically distinct from prior failed CD40-targeting programs from Novartis and Sanofi, arguing that targeting CD40 ligand on T cells addresses upstream T cell-B cell co-stimulation more broadly than receptor-level CD40 blockade. Sjögren's disease has no approved disease-modifying therapy, making these readouts a binary catalyst for the program.