Immunovant Shifts Focus to Next-Gen Anti-FcRn Asset, Discontinues Batoclimab for Myasthenia Gravis

Immunovant, a biopharmaceutical company specializing in autoimmune diseases, has announced a strategic shift in its drug development pipeline. Despite positive Phase III trial results for batoclimab in myasthenia gravis (MG), the company has decided to discontinue its development for this indication and chronic inflammatory demyelinating polyneuropathy (CIDP). Instead, Immunovant will concentrate its efforts on IMVT-1402, a next-generation anti-FcRn antibody.

Batoclimab's Phase III Results in Myasthenia Gravis

The Phase III trial for batoclimab in myasthenia gravis patients showed promising results after 12 weeks of treatment. Patients receiving a high dose of the drug experienced a 5.6-point improvement on a scale measuring aspects of living with MG, while those on a low dose saw a 4.7-point improvement. In comparison, the placebo group showed a 3.6-point improvement.

Analysts from Leerink Partners noted that these results aligned with expectations for anti-FcRn antibodies in general. They highlighted that the reduction in symptoms observed in the high-dose arm approached "the highest we have observed for any approved or developmental biologic therapy in MG."

Strategic Shift to IMVT-1402

Despite the positive data, Immunovant has decided not to pursue regulatory approval for batoclimab in myasthenia gravis or CIDP. The company's focus will now be on IMVT-1402, which has been cleared for clinical testing and is poised to enter pivotal trials.

Immunovant had previously signaled its intention to prioritize IMVT-1402 last year. The company plans to leverage the learnings from batoclimab's development to advance IMVT-1402, with pivotal tests expected to commence "imminently" in both myasthenia gravis and CIDP.

Market Response and Future Prospects

The announcement led to some volatility in Immunovant's stock. Shares initially dropped by approximately $5 but later recovered, showing a nearly 8% increase over the previous day's close, reaching $20.27 around 11 a.m. ET.

While batoclimab's development for MG and CIDP has been discontinued, the drug still has one remaining opportunity for market entry. Immunovant is awaiting Phase III study results for batoclimab in thyroid eye disease, which could potentially lead to its approval in that indication.

As the pharmaceutical landscape continues to evolve, Immunovant's strategic decision underscores the importance of pipeline optimization and the pursuit of next-generation therapies in the competitive autoimmune disease market.