FDA approves TECVAYLI plus DARZALEX FASPRO in second-line relapsed myeloma
The FDA approved Johnson & Johnson’s TECVAYLI (teclistamab-cqyv) + DARZALEX FASPRO (daratumumab/hyaluronidase-fihj) for Relapsed or refractory multiple myeloma, 1+ prior line on Mar 5, 2026. The company can now sell it in that market.
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- Company
- Johnson & Johnson JNJ
- Drug
- TECVAYLI (teclistamab-cqyv) + DARZALEX FASPRO (daratumumab/hyaluronidase-fihj)
- For
- Relapsed or refractory multiple myeloma, 1+ prior line
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Mar 5, 2026
- Source note
- J&J announced FDA approval of the teclistamab/daratumumab combination for relapsed or refractory multiple myeloma after at least one prior line, the first bispecific-based combination regimen in that setting.
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- Source: prnewswire.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
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- JNJ headlines on this site
The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve Johnson & Johnson’s IMAAVY (nipocalimab-aahu) for Warm autoimmune hemolytic anemia (wAIHA). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- FDA decision window for IMAAVY (nipocalimab) in warm autoimmune hemolytic anemia · FDA decision due (PDUFA date)
- Drug
- IMAAVY (nipocalimab-aahu)
- For
- Warm autoimmune hemolytic anemia (wAIHA)
- Stage
- sBLA under Priority Review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- J&J announced FDA Priority Review on April 27, 2026 (ENERGY Phase 3 data); the ~6-month priority clock implies a decision around late 2026, but J&J has not disclosed the exact PDUFA date. Would be the first approved wAIHA therapy.
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- Source: jnj.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
- JNJ headlines on this site
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Johnson & Johnson expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; J&J/BMS) 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.
More details
- Entry
- Phase 3 LIBREXIA-STROKE topline for milvexian (with BMS) · Clinical trial results (readout / topline data)
- Drug
- Milvexian (oral factor XIa inhibitor; J&J/BMS)
- 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
- Topline expected by end of 2026 per BMS Q2 2026 commentary (BioSpace, July 30, 2026). Shared 50/50 program with Bristol Myers Squibb — same event listed under BMY.
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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
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Johnson & Johnson expects to report results from its Phase 1/2 study of Icotyde (icotrokinra) for Active psoriatic arthritis in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.
More details
- Entry
- ICOTYDE (icotrokinra) pivotal Phase 3 ICONIC-PsA data in psoriatic arthritis · Clinical trial results (readout / topline data)
- Drug
- Icotyde (icotrokinra)
- For
- Active psoriatic arthritis
- Stage
- Phase 1/2 · an early study that checks safety and takes a first look at effect
- When
- H2 2026 · the company gave a window, not a day
- Source note
- J&J Q2 2026 earnings call (Jul 15, 2026) guidance; PsA readout flagged as a key H2 2026 catalyst.
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- Source: investing.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
- JNJ headlines on this site
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Johnson & Johnson expects to report results from its Phase 3 study of Inlexzo (TAR-200) for High-risk non-muscle invasive bladder cancer 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
- INLEXZO (TAR-200) additional Phase 3 data in high-risk NMIBC · Clinical trial results (readout / topline data)
- Drug
- Inlexzo (TAR-200)
- For
- High-risk non-muscle invasive bladder cancer
- 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
- J&J Q2 2026 earnings call lists INLEXZO HR-NMIBC readouts among H2 2026 catalysts.
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- Source: investing.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
- JNJ headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Johnson & Johnson expects to report results from its Phase 3 study of Caplyta (lumateperone) for Bipolar I mania 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
- CAPLYTA Phase 3 readout in bipolar mania · Clinical trial results (readout / topline data)
- Drug
- Caplyta (lumateperone)
- For
- Bipolar I mania
- 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
- J&J Q2 2026 earnings call H2 2026 catalyst list.
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- Source: investing.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
- JNJ headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Johnson & Johnson expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; J&J/BMS) 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; J&J/BMS)
- 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 guides LIBREXIA-AF topline to 2027 (year-level precision only). Shared program with BMS — same event listed under BMY.
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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
- JNJ headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page