Immunovant paid $39 million to exit batoclimab on Wednesday, booking the loss on its first-generation FcRn inhibitor after two phase 3 trials in thyroid eye disease couldn’t hit their primary endpoint.
Both studies, run with Korea-based partner HanAll, were designed around a single measure: a 2mm or greater reduction in proptosis at Week 24. Neither delivered it. Roivant, Immunovant’s majority shareholder, had disclosed the misses in early April but stopped short of calling batoclimab dead, saying it would review plans with HanAll at “a future date.” Wednesday’s earnings release removed all ambiguity. The $39M in contractual exit costs drove Immunovant’s fiscal-year R&D spend to $456.7 million from $360.9 million the year prior.
FcRn inhibitors have now struck out twice in TED. argenx stopped its UplighTED phase 3 studies of efgartigimod for futility in December 2025: same mechanism, same indication, same result. Two misses from different molecules raise a mechanism question: what can IgG suppression actually deliver for proptosis, and at what dose?
What does the buyer actually get? IMVT-1402, a second-generation FcRn blocker, with $902.1 million in cash behind it. Topline data from a proof-of-concept study in cutaneous lupus erythematosus is due in the second half of this year, with a Graves’ disease phase 2b readout expected next year. The RA data released Wednesday didn’t disappoint: 72.7% of 170 heavily pre-treated patients hit an ACR20 response at Week 16, with 54.5% reaching ACR50.
Shares jumped 20% in pre-market trading to $31.71.
Diana Kowalski