Shares of Immunovant IMVT are rising in the pre-market hours on Sept. 9 after the company announced positive data from the mid-stage study of its investigational candidate, batoclimab, which is being developed for Graves’ Disease (GD).
IMVT’s Batoclimab Shows Superior Efficacy in GD Patients
The enrolled patient population of the phase IIa study of batoclimab comprised uncontrolled GD patients who were hyperthyroid despite anti-thyroid drugs (ATD) therapy. Patients were then treated with the high batoclimab dose, 680 mg weekly subcutaneous injection (SC), for 12 weeks, followed by another 12 weeks of lower batoclimab dose, 340 mg weekly SC.
The data showed that treatment with the batoclimab 680 mg dose led to a mean Immunoglobin G (IgG) reduction of 77%, translating to a Response rate of 76% in the GD patient population after 12 weeks. Additionally, it was observed that at the end of the first 12 weeks, 56% of the patients treated with the high-dose of the candidate achieved an ATD-Free Response.
During the next 12 weeks of treatment with the batoclimab 340 mg dose, the mean IgG level was further reduced by 65%, with a correspondingly lower responder rate of 68%. Additionally, the ATD-Free Response rate dropped to 36% in the second 12 weeks.
Patients who experienced at least a 70% IgG reduction by the end of the study had an ATD-Free Response rate nearly three times higher than those who did not (60% and 23%, respectively).
Year to date, shares of Immunovant have plunged 19.2% compared with the industry’s 2.8% decline.
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Along with the data readout, Immunovant also revealed data from multiple proprietary market research studies, highlighting a persistent unmet need among patients treated with ATDs who are either intolerant to, uncontrolled or have relapsed after treatment with the same.
Per IMVT, real-world claims data shows that 25-30% of GD patients remain uncontrolled on ATDs each year, with few treatment options available. This presents a valuable commercial opportunity for the company with little competition.
IMVT’s Future Development Plans in Autoimmune Diseases
Leveraging the encouraging results from the phase IIa GD study ofbatoclimab, Immunovant is currently gearing up to initiate a pivotal study of its lead candidate, IMVT-1402, a novel and fully-human monoclonal antibody, for the same indication by the end of 2024.
In the press release, the company has also announced that it has aligned with the FDA regarding the impending pivotal study design and secured investigational new drug application clearance for IMVT-1402 to treat GD.
Apart from the GD study, separate mid to late-stage studies are also currently ongoing, evaluating batoclimab for the treatment of other autoimmune indications, like Myasthenia gravis, chronic inflammatory demyelinating polyneuropathy and thyroid eye disease. Subject to positive data from these studies, Immunovant plans to study IMVT-1402 for each of the above indications.
The company is on track to initiate four to five potentially registrational programs for IMVT-1402 over the next fiscal year (ending March 31, 2025). Over the next two fiscal years, the company plans to initiate studies in a total of 10 indications for IMVT-1402. The company also expects to achieve financial efficiencies in its IMVT-1402 development program by leveraging the data already available from batoclimab studies.
Immunovant, Inc. Price and Consensus
Immunovant, Inc. price-consensus-chart | Immunovant, Inc. Quote
Zacks Rank & Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. ILMN, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 10,7%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 48.5%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 26.5%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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