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FDA decisionH2 2026a window, not a day

FDA decision window for IMAAVY (nipocalimab) in warm autoimmune hemolytic anemia

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.

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary

DetailsFDA decision due · also called: PDUFA date
Company
Johnson & Johnson JNJ
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; the calendar never invents one
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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Phase 3 LIBREXIA-STROKE topline for milvexian (with BMS) · Clinical trial results (readout / topline data)
Drug
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For
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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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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsJNJJohnson & JohnsonH2 2026

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.

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ICOTYDE (icotrokinra) pivotal Phase 3 ICONIC-PsA data in psoriatic arthritis · Clinical trial results (readout / topline data)
Drug
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For
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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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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsJNJJohnson & JohnsonH2 2026

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INLEXZO (TAR-200) additional Phase 3 data in high-risk NMIBC · Clinical trial results (readout / topline data)
Drug
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For
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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
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Trial resultsJNJJohnson & JohnsonH2 2026

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.

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Entry
CAPLYTA Phase 3 readout in bipolar mania · Clinical trial results (readout / topline data)
Drug
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For
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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
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Trial resultsJNJJohnson & Johnson2027

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.

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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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Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page