- Immunovant Inc (NASDAQ: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.
