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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