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Immunovant (IMVT) Up on Positive Initial IMVT-1402 MAD Study Data
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Immunovant, Inc. (IMVT - Free Report) announced positive initial data from the 600 mg multiple-ascending dose (MAD) portion of its early-stage study on its new pipeline candidate, IMVT-1402.
The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered (SC) IMVT-1402 in healthy adults.
Immunovant’s next-generation FcRn inhibitor, IMVT-1402, is being developed as a SC injection.
Per the initial results of the study, four once-weekly SC doses of IMVT-1402 (600 mg) led to a mean dose-dependent reduction of 74% in immunoglobin G (IgG), a metric in the treatment of autoimmune diseases. This reflected that the candidate has a potency that is similar to a high dose of batoclimab but with minimal dose-related changes in serum albumin or LDL-C.
Shares of Immunovant were up 7.4% on Tuesday following the announcement of the news. The stock has skyrocketed 102.9% in the year-to-date period against the industry’s decline of 23.5%.
Image Source: Zacks Investment Research
In September 2023, the company announced positive initial data from both cohorts, the single-ascending dose (SAD) portion and the 300 mg MAD portion, of the phase I study on IMVT-1402.
Per the latest press release, the findings from the 600 mg MAD cohort on IMVT-1402 are consistent with the previously announced data from the 300 mg MAD cohort.
Importantly, treatment with IMVT-1402 was generally well tolerated across all the doses. Treatment-related adverse events were all mild or moderate.
The company believes that the initial findings on IMVT-1402 reaffirm the candidate’s potential to become a best-in-class FcRn inhibitor.
We note that Immunovant is developing its lead pipeline candidate batoclimab as an SC injection to treat autoimmune indications, including myasthenia gravis, thyroid eye disease, chronic inflammatory demyelinating polyneuropathy and Graves’ disease. Several mid-late-stage studies are currently ongoing on batoclimab targeting these indications.
In the absence of a marketed product, the successful development of batoclimab and other pipeline candidates holds the key for this clinical-stage immunology company.
Zacks Rank & Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 16.3%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have lost 7.5%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 3.1%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Immunovant (IMVT) Up on Positive Initial IMVT-1402 MAD Study Data
Immunovant, Inc. (IMVT - Free Report) announced positive initial data from the 600 mg multiple-ascending dose (MAD) portion of its early-stage study on its new pipeline candidate, IMVT-1402.
The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of subcutaneously administered (SC) IMVT-1402 in healthy adults.
Immunovant’s next-generation FcRn inhibitor, IMVT-1402, is being developed as a SC injection.
Per the initial results of the study, four once-weekly SC doses of IMVT-1402 (600 mg) led to a mean dose-dependent reduction of 74% in immunoglobin G (IgG), a metric in the treatment of autoimmune diseases. This reflected that the candidate has a potency that is similar to a high dose of batoclimab but with minimal dose-related changes in serum albumin or LDL-C.
Shares of Immunovant were up 7.4% on Tuesday following the announcement of the news. The stock has skyrocketed 102.9% in the year-to-date period against the industry’s decline of 23.5%.
In September 2023, the company announced positive initial data from both cohorts, the single-ascending dose (SAD) portion and the 300 mg MAD portion, of the phase I study on IMVT-1402.
Per the latest press release, the findings from the 600 mg MAD cohort on IMVT-1402 are consistent with the previously announced data from the 300 mg MAD cohort.
Importantly, treatment with IMVT-1402 was generally well tolerated across all the doses. Treatment-related adverse events were all mild or moderate.
The company believes that the initial findings on IMVT-1402 reaffirm the candidate’s potential to become a best-in-class FcRn inhibitor.
We note that Immunovant is developing its lead pipeline candidate batoclimab as an SC injection to treat autoimmune indications, including myasthenia gravis, thyroid eye disease, chronic inflammatory demyelinating polyneuropathy and Graves’ disease. Several mid-late-stage studies are currently ongoing on batoclimab targeting these indications.
In the absence of a marketed product, the successful development of batoclimab and other pipeline candidates holds the key for this clinical-stage immunology company.
Zacks Rank & Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CytomX Therapeutics, Inc. (CTMX - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each.You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 16.3%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have lost 7.5%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 3.1%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.