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Immunovant (IMVT) Soars on Upbeat Initial IMVT-1402 Study Data
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Immunovant, Inc. (IMVT - Free Report) , a clinical-stage company, announced positive initial results from both cohorts, the single-ascending dose (SAD) portion and the multiple-ascending dose (MAD) portion, of its early-stage study of IMVT-1402.
The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered (SC) IMVT-1402, which is Immunovant’s next-generation FcRn inhibitor, in healthy adults.
Per the initial results from the study, it was observed that the SC doses of IMVT-1402 caused dose-dependent reductions in immunoglobin G (IgG) in healthy adults, with no dose-related changes in serum albumin or LDL-C. Management believes that these initial findings reaffirm IMVT-1402’s potential to become a best-in-class FcRn inhibitor.
IMVT-1402 is being developed as a SC injection.
The company’s stock shot up 97% in the last trading session in response to the encouraging initial update from the phase I study of IMVT-1402. Year to date, shares of Immunovant have skyrocketed 125.1% against the industry’s 16.2% fall.
Image Source: Zacks Investment Research
In the SAD portion of the study, treatment with IMVT-1402 SC demonstrated a consistent reduction in IgG, a metric in the treatment of autoimmune diseases, with potency that is similar to or greater than that of batoclimab (formerly IMVT-1401).
The safety profile of the candidate in the SAD cohort was found to be generally favorable. Adverse events on treatment with IMVT-1402 were all mild or moderate. Furthermore, no significant reduction from baseline in serum albumin (the main protein of human blood plasma) or increase in LDL-C (bad cholesterol) was observed at any instance.
IMVT also announced initial MAD results for the IMVT-1402 300 mg cohort, ahead of schedule. The company reported that the mean total IgG reduction from baseline in the MAD cohort was 63%, with no decrease in serum albumin below baseline and no increase in LDL-C above baseline, which was observed after four weekly 300 mg SC doses of IMVT-1402.
The safety profile of IMVT-1402 in the MAD cohort was also favorable. Treatment-related adverse events were all mild or moderate.
Immunovant is also currently evaluating its lead candidate, batoclimab, in the treatment of several autoimmune diseases mediated by pathogenic IgG antibodies, with an initial focus on the treatment of myasthenia gravis and thyroid eye disease. Other indications include chronic inflammatory demyelinating polyneuropathy and Graves’ disease.
In a separate press release, Immunovant also announced initiating a proposed underwritten public offering and concurrent private placement of an aggregate of $300,000,000 of shares of its common stock.
The underwritten public offering portion constitutes an offer to sell $130,000,000 of shares of its common stock. Additionally, Immunovant intends to further grant the underwriters a 30-day option to purchase up to an additional $19,500,000 of shares of its common stock offered at the public offering price.
IMVT intends to sell the remaining $170,000,000 of shares of its common stock to Roivant Sciences Ltd. (ROIV - Free Report) . Immunovant is a subsidiary of Roivant.
Shares of Roivant also soared about 21.6% in the last trading session, after Immunovant announced positive initial results from its phase I study of IMVT-1402.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 33.9%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 59.9%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Immunovant (IMVT) Soars on Upbeat Initial IMVT-1402 Study Data
Immunovant, Inc. (IMVT - Free Report) , a clinical-stage company, announced positive initial results from both cohorts, the single-ascending dose (SAD) portion and the multiple-ascending dose (MAD) portion, of its early-stage study of IMVT-1402.
The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered (SC) IMVT-1402, which is Immunovant’s next-generation FcRn inhibitor, in healthy adults.
Per the initial results from the study, it was observed that the SC doses of IMVT-1402 caused dose-dependent reductions in immunoglobin G (IgG) in healthy adults, with no dose-related changes in serum albumin or LDL-C. Management believes that these initial findings reaffirm IMVT-1402’s potential to become a best-in-class FcRn inhibitor.
IMVT-1402 is being developed as a SC injection.
The company’s stock shot up 97% in the last trading session in response to the encouraging initial update from the phase I study of IMVT-1402. Year to date, shares of Immunovant have skyrocketed 125.1% against the industry’s 16.2% fall.
Image Source: Zacks Investment Research
In the SAD portion of the study, treatment with IMVT-1402 SC demonstrated a consistent reduction in IgG, a metric in the treatment of autoimmune diseases, with potency that is similar to or greater than that of batoclimab (formerly IMVT-1401).
The safety profile of the candidate in the SAD cohort was found to be generally favorable. Adverse events on treatment with IMVT-1402 were all mild or moderate. Furthermore, no significant reduction from baseline in serum albumin (the main protein of human blood plasma) or increase in LDL-C (bad cholesterol) was observed at any instance.
IMVT also announced initial MAD results for the IMVT-1402 300 mg cohort, ahead of schedule. The company reported that the mean total IgG reduction from baseline in the MAD cohort was 63%, with no decrease in serum albumin below baseline and no increase in LDL-C above baseline, which was observed after four weekly 300 mg SC doses of IMVT-1402.
The safety profile of IMVT-1402 in the MAD cohort was also favorable. Treatment-related adverse events were all mild or moderate.
Immunovant is also currently evaluating its lead candidate, batoclimab, in the treatment of several autoimmune diseases mediated by pathogenic IgG antibodies, with an initial focus on the treatment of myasthenia gravis and thyroid eye disease. Other indications include chronic inflammatory demyelinating polyneuropathy and Graves’ disease.
In a separate press release, Immunovant also announced initiating a proposed underwritten public offering and concurrent private placement of an aggregate of $300,000,000 of shares of its common stock.
The underwritten public offering portion constitutes an offer to sell $130,000,000 of shares of its common stock. Additionally, Immunovant intends to further grant the underwriters a 30-day option to purchase up to an additional $19,500,000 of shares of its common stock offered at the public offering price.
IMVT intends to sell the remaining $170,000,000 of shares of its common stock to Roivant Sciences Ltd. (ROIV - Free Report) . Immunovant is a subsidiary of Roivant.
Shares of Roivant also soared about 21.6% in the last trading session, after Immunovant announced positive initial results from its phase I study of IMVT-1402.
Zacks Rank and Stocks to Consider
Immunovant currently has a Zacks Rank #3 (Hold).
A few better-ranked stocks in the same industry, are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 33.9%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 59.9%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.