Immunovant To Start Pivotal Batoclimab Trials In Thyroid Eye Disease Later This Year

Immunovant Inc IMVT has aligned with the FDA Division of Ophthalmology on plans to initiate two placebo-controlled Phase 3 trials to evaluate batoclimab in thyroid eye disease (TED).
Immunovant expects to initiate its Phase 3 TED program in 2H of 2022 and is expected to enroll about 100 subjects for each trial.
Topline results from both trials are expected in 1H of 2025.
Immunovant's upcoming Phase 3 TED trials represent the company's second pivotal program, with a Phase 3 pivotal trial in myasthenia gravis (MG) expected to initiate by the end of June 2022 and a topline readout expected in 2H of 2024.
The company continues to make meaningful progress on additional strategic priorities for batoclimab's broad development and expects to announce two new indications by August 2022.
Immunovant held a Q1 cash balance of $493.8 million, sufficient to fund its operating expenses and capital expenditure requirements into 2025.
Price Action: IMVT shares closed 3.14% higher at $4.27 on Tuesday.

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