- Trial Phase
- Approved (first indication); NDA under FDA review for wAIHA
- Time to Market
- Already approved and commercializing (FDA approval catalyst recorded 2025-04-29). The wAIHA label expansion decision is undated in available data; a standard NDA review would land roughly a year from the April 14, 2026 submission.
- Why 4/10
- The next hard catalyst is an FDA decision on the wAIHA NDA (submitted 2026-04-14), but no PDUFA date is recorded in available data and the drug is a tiny fraction of a mega-cap, so the score sits in the approved-drug bracket (3-5) at 4.
Watch for FDA acceptance of the wAIHA NDA and a PDUFA date (likely announced via a J&J press release/8-K; a standard ~10-month review from the April 2026 filing would point to early 2027). For JNJ holders this is a slow-burn label-expansion story, not a binary event — the approval day moved the stock only +0.62% and the NDA submission +0.3% — so size any position accordingly. Track the gMG/wAIHA competitive field (VYVGART, cemdisiran, sovleplenib, povetacicept) and quarterly IMAAVY sales disclosures.
Price Chart
Executive Summary
IMAAVY is J&J's brand for nipocalimab, an anti-FcRn antibody already approved (FDA approval catalyst recorded 2025-04-29) with a second NDA filed 2026-04-14 for warm autoimmune hemolytic anemia and Fast Track in SLE — a genuine label-expansion story at a blue-chip. But at Johnson & Johnson's scale the drug barely moves the stock (approval day +0.62%, NDA filing +0.3%), no wAIHA PDUFA date is on record yet, and the gMG/wAIHA fields are crowded (VYVGART/VYVGART Hytrulo, cemdisiran, UPLIZNA, sovleplenib, povetacicept). Net investor read: a real but minor, slow-burn driver — mixed.
How It Works
IMAAVY (nipocalimab-aahu; the suffix marks it as a human monoclonal antibody) is an infused lab-made antibody that blocks a protein called FcRn, which normally protects antibodies from being broken down. By blocking it, the drug rapidly lowers the level of circulating antibodies — including the misdirected self-attacking antibodies that destroy red blood cells in warm autoimmune hemolytic anemia and attack nerve-muscle connections in myasthenia gravis.
Trial Status
Internal SEC-derived catalyst data records an FDA approval for IMAAVY on 2025-04-29; on 2026-04-14 J&J submitted an NDA for IMAAVY (nipocalimab-aahu) in warm autoimmune hemolytic anemia (wAIHA, high-confidence record tied to the 8-K filed that day) and received Fast Track designation for nipocalimab in systemic lupus erythematosus (SLE). No PDUFA date is yet recorded for the wAIHA filing.
The Two-Sided Case
Upcoming Catalysts
- FDA acceptance of the wAIHA NDA and assignment of a PDUFA date (undated as of the last recorded data; a standard review would point to early 2027)
- Progress on the SLE program under Fast Track designation (Phase 3 data updates)
- Quarterly IMAAVY sales disclosures in J&J earnings reports (next 10-Q / earnings 8-K)
Source Filing
The SecBot filing or press-release report that triggered this drug report:
JOHNSON & JOHNSON 8-K JNJ ·Originating report