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Immunovant (IMVT) Up on Upbeat Initial Batoclimab GD Study Data
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Immunovant, Inc. (IMVT - Free Report) announced top-line results from the initial cohort of patients in an ongoing 24-week phase II study of batoclimab in patients with Graves’ disease (GD), observing more than 50% clinically meaningful response rates.
Batoclimab is Immunovant’s novel, a fully-human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor.
Per the data readout, treatment with the 680 mg dose strength of batoclimab, administered subcutaneously (SC), in the initial cohort resulted in potential best-in-class Immunoglobin G (IgG) reduction, up to 87%, with a mean IgG reduction of 81% after 12 weeks of treatment. However, treatment with the 340 mg dose of batoclimab led to lower IgG reductions.
Immunovant further reported that the higher dose of batoclimab also led to deeper reductions of anti-TSHR autoantibodies, which are often responsible for hyperthyroidism. Besides these, higher response rates on treatment with the 640 mg dose of batoclimab were observed across a range of clinical parameters compared to treatment with 340 mg of batoclimab.
Overall, the candidate was well-tolerated and no new safety concerns were observed in the initial data set.
Immunovant’s stock gained about 12% during the after-hours, which followed the encouraging data announcement after market close on Dec 20, 2023. Year to date, shares of IMVT have skyrocketed 103.8% against the industry’s 16.9% decline.
Image Source: Zacks Investment Research
The phase II proof-of-concept study is evaluating the safety and efficacy of batoclimab in treating GD. The study is currently enrolling patients who are hyperthyroid despite treatment with an anti-thyroid medication (ATD) for more than 12 weeks. The enrolled patients are then administered with once-weekly SC injections of 680 mg batoclimab for 12 weeks, followed by once-weekly SC injections of 340 mg batoclimab for another 12 weeks.
Per Immunovant, treatment response is defined as the normalization of T3 and T4 hormone levels without increasing ATD dose. The primary and secondary endpoints of the study are being assessed at weeks 12 and 24.
The distinct design of the mid-stage study allowed for efficacy assessments between two distinct ranges of IgG reductions.
Immunovant is also developing batoclimab in several separate late-stage studies for other autoimmune indications. The company is developing batoclimab with an initial focus on the treatment of myasthenia gravis (MG), an autoimmune disease associated with muscle weakness and thyroid eye disease(TED), an autoimmune inflammatory disorder that affects the muscles and other tissues around the eyes, which can threaten vision.
Immunovant’s pivotal study evaluating batoclimab for the treatment of MG is currently ongoing. Top-line data from the same is expected in the second half of the calendar year 2024. The company is also evaluating batoclimab for TED in two late-stage studies. Top-line data from both studies are expected in the first half of the calendar year 2025.
Immunovant is also evaluating batoclimab for a fourth indication, chronic inflammatory demyelinating polyneuropathy (CIDP). Its late-stage CIDP study on batoclimab is also currently ongoingwith top-line results expected in the first half of the calendar year 2024.
The company has another investigational candidate in its pipeline, IMVT-1402, a next-generation FcRn inhibitor, currently being evaluated in an early-stage study. The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of SC-administered IMVT-1402.
Despite the ongoing GD study of batoclimab, Immunovant intends to focus its future development in GD on IMVT-1402. Per the press release, the company expects to share further details later in 2024.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 7.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 5.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 68.6%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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Immunovant (IMVT) Up on Upbeat Initial Batoclimab GD Study Data
Immunovant, Inc. (IMVT - Free Report) announced top-line results from the initial cohort of patients in an ongoing 24-week phase II study of batoclimab in patients with Graves’ disease (GD), observing more than 50% clinically meaningful response rates.
Batoclimab is Immunovant’s novel, a fully-human monoclonal antibody that selectively binds to and inhibits the neonatal fragment crystallizable receptor.
Per the data readout, treatment with the 680 mg dose strength of batoclimab, administered subcutaneously (SC), in the initial cohort resulted in potential best-in-class Immunoglobin G (IgG) reduction, up to 87%, with a mean IgG reduction of 81% after 12 weeks of treatment. However, treatment with the 340 mg dose of batoclimab led to lower IgG reductions.
Immunovant further reported that the higher dose of batoclimab also led to deeper reductions of anti-TSHR autoantibodies, which are often responsible for hyperthyroidism. Besides these, higher response rates on treatment with the 640 mg dose of batoclimab were observed across a range of clinical parameters compared to treatment with 340 mg of batoclimab.
Overall, the candidate was well-tolerated and no new safety concerns were observed in the initial data set.
Immunovant’s stock gained about 12% during the after-hours, which followed the encouraging data announcement after market close on Dec 20, 2023. Year to date, shares of IMVT have skyrocketed 103.8% against the industry’s 16.9% decline.
Image Source: Zacks Investment Research
The phase II proof-of-concept study is evaluating the safety and efficacy of batoclimab in treating GD. The study is currently enrolling patients who are hyperthyroid despite treatment with an anti-thyroid medication (ATD) for more than 12 weeks. The enrolled patients are then administered with once-weekly SC injections of 680 mg batoclimab for 12 weeks, followed by once-weekly SC injections of 340 mg batoclimab for another 12 weeks.
Per Immunovant, treatment response is defined as the normalization of T3 and T4 hormone levels without increasing ATD dose. The primary and secondary endpoints of the study are being assessed at weeks 12 and 24.
The distinct design of the mid-stage study allowed for efficacy assessments between two distinct ranges of IgG reductions.
Immunovant is also developing batoclimab in several separate late-stage studies for other autoimmune indications. The company is developing batoclimab with an initial focus on the treatment of myasthenia gravis (MG), an autoimmune disease associated with muscle weakness and thyroid eye disease(TED), an autoimmune inflammatory disorder that affects the muscles and other tissues around the eyes, which can threaten vision.
Immunovant’s pivotal study evaluating batoclimab for the treatment of MG is currently ongoing. Top-line data from the same is expected in the second half of the calendar year 2024. The company is also evaluating batoclimab for TED in two late-stage studies. Top-line data from both studies are expected in the first half of the calendar year 2025.
Immunovant is also evaluating batoclimab for a fourth indication, chronic inflammatory demyelinating polyneuropathy (CIDP). Its late-stage CIDP study on batoclimab is also currently ongoingwith top-line results expected in the first half of the calendar year 2024.
The company has another investigational candidate in its pipeline, IMVT-1402, a next-generation FcRn inhibitor, currently being evaluated in an early-stage study. The phase I study is evaluating the safety, tolerability and pharmacodynamic profiles of SC-administered IMVT-1402.
Despite the ongoing GD study of batoclimab, Immunovant intends to focus its future development in GD on IMVT-1402. Per the press release, the company expects to share further details later in 2024.
Immunovant, Inc. Price and Consensus
Immunovant, Inc. price-consensus-chart | Immunovant, Inc. Quote
Zacks Rank and Stocks to Consider
Immunovant currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 7.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have gained 5.2%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 68.6%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.