FDA flags fatal liver injury cases with Amgen's TAVNEOS
FDA flags fatal liver injury cases with Amgen's TAVNEOS, on Mar 31, 2026. A company milestone for Amgen (TAVNEOS (avacopan) for Severe active ANCA-associated vasculitis): a step in the program rather than a decision or a data readout.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Amgen Inc. AMGN
- Drug
- TAVNEOS (avacopan)
- For
- Severe active ANCA-associated vasculitis
- Stage
- Marketed
- When
- Mar 31, 2026
- Source note
- FDA issued a Drug Safety Communication about serious postmarketing drug-induced liver injury, including fatal cases and vanishing bile duct syndrome, associated with Tavneos (avacopan). The label was subsequently updated with additional liver monitoring guidance.
- Checked
- Checked by a person when it was added
- Source: fda.gov ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AMGN headlines on this site
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.
More details
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: amgen.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AMGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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'.
- Checked
- Checked by a person when it was added
- Verify it
- Source: theglobeandmail.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AMGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- Entry
- EC decision on Repatha label expansion for primary prevention (VESALIUS-CV) · Regulatory approval
- 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
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: amgen.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- AMGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: amgen.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AMGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: amgen.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AMGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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'.
- Checked
- Checked by a person when it was added
- Verify it
- Source: fiercebiotech.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AMGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page