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batoclimab

Immunovant · $IMVT
Standard Review Phase 3 Breakthrough Therapy
Catalyst Date
August 15, 2026
Time Remaining
142 days
Review Type
Standard (10 mo)

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Indication

Thyroid eye disease (TED)

Key Notes

FORTIFY Phase 3 trial data expected H2 2026. Batoclimab is an anti-FcRn antibody. Competitor to Tepezza. Immunovant's next-gen candidate IMVT-1402 is also in Phase 3 trials across 6 autoimmune indications. Immunovant fiscal year ends March 31 — next earnings update ~May/June 2026.
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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