Immunovant (IMVT) Set to Develop Lead Candidate Batoclimab

Immunovant, Inc. IMVT is making good progress with the development of its lead pipeline candidate, batoclimab (formerly IMVT-1401), which is being developed for treating several autoimmune diseases.

Batoclimab is a fully human, monoclonal antibody that selectively binds to and inhibits neonatal fragment crystallizable receptors (FcRn). The candidate is being developed as a subcutaneous injection for the treatment of myasthenia gravis (“MG”), warm autoimmune hemolytic anemia (“WAIHA”) and thyroid eye disease (“TED”). IMVT is making rapid progress in batoclimab’s development this year.

Shares of Immunovant have rallied 8.5% so far this year against the industry’s decline of 27.1%.

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Last month, IMVT announced plans to develop batoclimab for two new indications, Chronic Inflammatory Demyelinating Polyneuropathy and Graves’ Disease.

The company is looking to initiate a pivotal phase IIb study evaluating batoclimab for treating Chronic Inflammatory Demyelinating in the second half of 2022. The company also plans to start another phase II study on batoclimab for treating Graves’ Disease in early 2023.

In June 2022, Immunovant initiated a pivotal study evaluating batoclimab for the treatment of MG. Top-line data from the same is expected in the second half of 2024.

During the same period, the company also achieved alignment with the FDA’s Division of Ophthalmology to initiate two phase III studies evaluating batoclimab for treating TED. Both studies are expected to begin in the second half of 2022. Top-line data from both are expected in the first half of 2025.

The company also plans to initiate a placebo-controlled study on batoclimab as a treatment for WAIHA, contingent on discussions with the hematology division of the FDA, which is expected to take place later in 2022.

In September, Immunovant announced that it plans to begin a phase I study on its new anti-FcRn, IMVT-1402 in early 2023, contingent on IND clearance. Initial data from the same is expected in mid-2023.

The encouraging pipeline progress with batoclimab has maintained momentum for IMVT.

However, in the absence of a marketed drug, the successful development of batoclimab remains the main focus of Immunovant. Moreover, batoclimab is still in late-stage development and is still a few years away from commercialization. Any developmental setback for batoclimab will be a major setback for the company, leaving an adverse impact on its shares.

Zacks Rank & Stocks to Consider

Immunovant currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering in the biotech sector are Acadia Pharmaceuticals Inc. ACAD, ORIC Pharmaceuticals, Inc. ORIC and Aeglea BioTherapeutics, Inc. AGLE, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss per share estimates for Acadia narrowed 0.7% for 2022 and 2.9% for 2023 in the past 60 days.

Earnings of Acadia surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ACAD delivered an earnings surprise of 6.83%, on average.

Loss per share estimates for ORIC Pharmaceuticals narrowed 5.9% for 2022 and 7.3% for 2023 in the past 60 days.

Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the other occasion. ORIC delivered an earnings surprise of 8.85%, on average.

Loss per share estimates for Aeglea BioTherapeutics narrowed 3.5% for 2022 and 1.2% for 2023 in the past 60 days.

Earnings of Aeglea BioTherapeutics surpassed estimates in one of the trailing four quarters and missed on the other three occasions. AGLE delivered a negative earnings surprise of 3.34%, on average.

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