FDA approves Opdivo plus AVD for untreated stage III/IV Hodgkin lymphoma
The FDA approved Bristol-Myers Squibb Company’s Opdivo (nivolumab) + AVD for Previously untreated stage III/IV classical Hodgkin lymphoma on Mar 20, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Bristol-Myers Squibb Company BMY
- Drug
- Opdivo (nivolumab) + AVD
- For
- Previously untreated stage III/IV classical Hodgkin lymphoma
- Stage
- Regulatory (sBLA)
- When
- Mar 20, 2026
- Source note
- FDA cleared nivolumab with doxorubicin, vinblastine and dacarbazine for patients 12 and older with previously untreated stage III or IV classical Hodgkin lymphoma, based on a 994-patient study showing better PFS than brentuximab vedotin.
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- Source: cancernetwork.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
- BMY headlines on this site
Bristol-Myers Squibb Company expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; BMS/Johnson & Johnson) for Secondary stroke prevention 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
- Phase 3 LIBREXIA-STROKE topline for milvexian (with J&J) · Clinical trial results (readout / topline data)
- Drug
- Milvexian (oral factor XIa inhibitor; BMS/Johnson & Johnson)
- For
- Secondary stroke prevention
- 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
- Per BioSpace's July 30, 2026 coverage of BMS Q2 earnings, LIBREXIA-STROKE findings remain expected by end of 2026. Program context: LIBREXIA-ACS was discontinued in Nov 2025 after interim futility; STROKE and AF continue.
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- Source: biospace.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
- BMY headlines on this site
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Bristol-Myers Squibb Company expects to report results from its Phase 3 study of Cobenfy (xanomeline-trospium) for Alzheimer's disease psychosis (ADEPT-1) 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
- Cobenfy ADEPT-1 ADP possible interim analysis and open-label lead-in data · Clinical trial results (readout / topline data)
- Drug
- Cobenfy (xanomeline-trospium)
- For
- Alzheimer's disease psychosis (ADEPT-1)
- 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
- Fierce Pharma July 30, 2026 on BMS Q2 call: full ADEPT program readouts pushed to begin in early 2027 and be spread across the year, but an ADEPT-1 interim and open-label lead-in data are possible later in 2026.
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- Source: fiercepharma.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
- BMY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Bristol-Myers Squibb Company expects to report results from its Phase 3 study of milvexian for Stroke prevention in atrial fibrillation (LIBREXIA-AF) in Q1 2027 (Jan–Mar) (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
- LIBREXIA-AF milvexian Ph3 AF stroke prevention readout now Q1 2027 · Clinical trial results (readout / topline data)
- Drug
- milvexian
- For
- Stroke prevention in atrial fibrillation (LIBREXIA-AF)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q1 2027 · the company gave a window, not a day
- Source note
- existing item 'BMY|readout|2027|LIBREXIA-AF milvexian' is now more precisely guided to Q1 2027 per BMS Q2 2026 earnings commentary (Fierce Pharma, July 30, 2026); previously expected in 2026.
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- Source: fiercepharma.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
- BMY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Bristol-Myers Squibb Company expects to report results from its Phase 3 study of Cobenfy (xanomeline/trospium) for Psychosis associated with Alzheimer's disease (ADEPT-1/2/4) 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
- Cobenfy ADEPT Alzheimer's psychosis readouts begin early 2027 · Clinical trial results (readout / topline data)
- Drug
- Cobenfy (xanomeline/trospium)
- For
- Psychosis associated with Alzheimer's disease (ADEPT-1/2/4)
- 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
- CEO Chris Boerner said ADEPT program topline readouts are now anticipated to begin in early 2027 and be spread across the year, with a potential ADEPT-1 interim analysis in late 2026. Timeline slipped after site 'irregularities' in ADEPT-2 and slower enrollment/event accrual.
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- Source: biospace.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
- BMY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Bristol-Myers Squibb Company expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; BMS/Johnson & Johnson) for Stroke prevention in atrial fibrillation during 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
- Phase 3 LIBREXIA-AF topline for milvexian delayed to 2027 · Clinical trial results (readout / topline data)
- Drug
- Milvexian (oral factor XIa inhibitor; BMS/Johnson & Johnson)
- For
- Stroke prevention in atrial fibrillation
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2027 · the company gave a window, not a day
- Source note
- BMS's Q2 2026 earnings presentation moved the LIBREXIA-AF topline readout to 2027 (previously guided 2026). Year-level precision only; no quarter given.
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- Source: sec.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
- BMY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page