Immunovant Shifts Focus to Next-Generation Drug Despite Positive Trial Results

Immunovant, a biotechnology company specializing in autoimmune diseases, has announced positive results from late-stage clinical trials for its drug batoclimab. However, the company has made the strategic decision to prioritize the development of its next-generation drug, IMVT-1402, over seeking immediate regulatory approval for batoclimab.

Batoclimab Shows Promise in Phase 3 and Phase 2b Trials

Immunovant reported that batoclimab, an FcRn inhibitor, succeeded in a Phase 3 study for myasthenia gravis and the first part of a Phase 2b trial for an unspecified immune condition affecting nerves. These results demonstrate the drug's potential efficacy in treating autoimmune disorders. Despite these positive outcomes, Immunovant does not currently plan to submit batoclimab for regulatory approval in these indications.

Strategic Shift Towards IMVT-1402

The company's decision to focus on IMVT-1402 stems from its belief that this next-generation drug has "best-in-class" potential. Immunovant intends to leverage data and insights gained from batoclimab studies to inform and accelerate the development of IMVT-1402. This strategic pivot was first announced in May 2024 when the company delayed timelines for batoclimab's mid- to late-stage trials.

IMVT-1402 is expected to offer improvements over batoclimab, including better tolerability for patients and potentially deeper and more durable responses. Additionally, Immunovant plans to position IMVT-1402 as the only drug in its class available in an autoinjector format, potentially allowing for self-administration at home.

Market Response and Future Plans

The announcement of positive trial results coupled with the strategic shift towards IMVT-1402 has been met with a mixed market response. Immunovant's stock price initially climbed 6% to nearly $20 per share, while shares of its parent company, Roivant Sciences, also saw a modest increase before stabilizing.

Looking ahead, Immunovant has ambitious plans for IMVT-1402, with expectations to have four to five potentially registrational trials underway in the near term. The company aims to study the drug in as many as 10 different indications by the end of March next year, signaling a broad and aggressive development strategy for its next-generation FcRn inhibitor.