PDUFA mezigdomide + carfilzomib/dex (MeziKd) in RRMM
The FDA is due to decide by May 13, 2027 whether to approve Bristol-Myers Squibb Company’s mezigdomide for Relapsed or refractory multiple myeloma (SUCCESSOR-2). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Bristol-Myers Squibb Company BMY
- Drug
- mezigdomide
- For
- Relapsed or refractory multiple myeloma (SUCCESSOR-2)
- Stage
- NDA
- When
- May 13, 2027
- Source note
- BMS July 13, 2026 release: FDA accepted the NDA for mezigdomide in combination with carfilzomib and dexamethasone based on Phase 3 SUCCESSOR-2 (52% reduction in risk of progression or death vs Kd). SUCCESSOR-1 remains ongoing.
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- Source: news.bms.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
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 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.
More details
- 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.
More details
- 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.
- Checked
- Checked by a person when it was added
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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