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ApprovalH2 2026a window, not a day

EC decision on Repatha label expansion for primary prevention (VESALIUS-CV)

Amgen expects European regulators to decide on Repatha (evolocumab) for Broader use before a first heart attack or stroke (VESALIUS-CV label expansion) in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.

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DetailsRegulatory approval
Company
Amgen Inc. AMGN
Drug
Repatha (evolocumab)
For
Broader use before a first heart attack or stroke (VESALIUS-CV label expansion)
Stage
Regulatory
When
H2 2026 · the company gave a window, not a day; the calendar never invents one
Source note
July 29, 2026 PR announcing positive CHMP opinion; company only says EC decision expected 'in the coming months' (timing vague, mapped to 2026-H2). EC typically acts ~2 months after CHMP.
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Amgen Inc.
AMGN
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MilestoneAMGNAmgen2026

Three MariTide Phase 3 studies in type 2 diabetes to start in 2026, expected during 2026 (no exact date yet). A company milestone for Amgen (MariTide (maridebart cafraglutide) for Type 2 diabetes): a step in the program rather than a decision or a data readout.

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Entry
Three MariTide Phase 3 studies in type 2 diabetes to start in 2026 · Company milestone
Drug
MariTide (maridebart cafraglutide)
For
Type 2 diabetes
Stage
Phase 3 · the last stage before a drug can be approved
When
2026 · the company gave a window, not a day
Source note
Q2 2026 release; source only says 'in 2026' so remaining 2026 window applies.
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Trial resultsAMGNAmgenH2 2026

Amgen expects to report results from its Phase 3 study of dazodalibep for Sjogren's disease (systemic and symptomatic Phase 3 studies) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.

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Entry
Dazodalibep Phase 3 Sjogren's disease results · Clinical trial results (readout / topline data)
Drug
dazodalibep
For
Sjogren's disease (systemic and symptomatic Phase 3 studies)
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
On the Q2 2026 earnings call (Aug 4, 2026) Amgen said Phase 3 results from the systemic (621 patients) and symptomatic (434 patients) Sjogren's studies are 'expected later this year'.
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MilestoneAMGNAmgenH2 2026

TEZSPIRE Phase 3 eosinophilic esophagitis study completion, expected in the second half of 2026 (no exact date yet). A company milestone for Amgen (TEZSPIRE (tezepelumab) for Eosinophilic esophagitis): a step in the program rather than a decision or a data readout.

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Entry
TEZSPIRE Phase 3 eosinophilic esophagitis study completion · Company milestone
Drug
TEZSPIRE (tezepelumab)
For
Eosinophilic esophagitis
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 release: 'A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026.' Note this is study completion, not an explicit topline-date guidance.
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MilestoneAMGNAmgenH2 2026

UPLIZNA Phase 3 CIDP study initiation, expected in the second half of 2026 (no exact date yet). A company milestone for Amgen (UPLIZNA (inebilizumab) for Chronic inflammatory demyelinating polyneuropathy): a step in the program rather than a decision or a data readout.

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Entry
UPLIZNA Phase 3 CIDP study initiation · Company milestone
Drug
UPLIZNA (inebilizumab)
For
Chronic inflammatory demyelinating polyneuropathy
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 release guides the CIDP Phase 3 start to an H2 2026 - H1 2027 window; dated to the start of that window.
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Trial resultsAMGNAmgenH1 2027

Amgen expects to report results from its Phase 3 study of MariTide (maridebart cafraglutide) for Chronic weight management in obesity/overweight (MARITIME-1) and obesity with Type 2 diabetes (MARITIME-2) in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.

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Entry
MariTide Phase 3 MARITIME-1 and MARITIME-2 obesity topline data · Clinical trial results (readout / topline data)
Drug
MariTide (maridebart cafraglutide)
For
Chronic weight management in obesity/overweight (MARITIME-1) and obesity with Type 2 diabetes (MARITIME-2)
Stage
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
Primary readouts of the 72-week MARITIME-1 (~3,500 participants) and MARITIME-2 (~999 participants) trials are reported to be expected at the start of 2027. Amgen itself has not press-released a precise readout date, calling 2026 'a year of very disciplined data generation'.
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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page