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Intra-Cellular (ITCI) Up as Depression Drug Meets Study Goals
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Intra-Cellular Therapies, Inc. (ITCI - Free Report) announced positive top-line results from its late-stage study evaluating lumateperone 42 mg for the treatment of major depressive disorder (MDD). The stock climbed 23.3% on Apr 16 following the encouraging news. The stock hit a new 52-week high on Tuesday, driven by the significant pipeline development.
The phase III study, called Study 501, evaluating lumateperone 42 mg given once daily as an adjunctive therapy to antidepressants for MDD, met the primary endpoint. A statistically significant and clinically meaningful reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score was observed compared with placebo at week six.
MADRS is a metric showing the improvement of depressive symptoms in MDD patients compared with placebo after the treatment period.
Intra-Cellular also reported that the key secondary endpoint was also achieved by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale score, which is a measure of severity of illness compared with placebo at week six.
Statistically significant efficacy upon treatment of MDD patients with lumateperone 42 mg was observed as early as after one week of dosing, which was maintained throughout the study in the primary and key secondary endpoints.
Additionally, feedback from MDD patients, as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16), demonstrated that lumateperone 42 mg robustly improved depressive symptoms. The QIDS-SR-16 contains 16 items that evaluate symptom severity in depression as rated by the patients themselves.
The nine key symptoms of depression assessed by the QIDS-SR-16 are insomnia/hypersomnia, low mood, appetite/weight changes, impaired self-perception, concentration difficulties, loss of interest/pleasure, suicidal ideation, psychomotor agitation and fatigue.
Year to date, shares of ITCI have gained 11.5% against the industry’s 8.9% decline.
Image Source: Zacks Investment Research
Please note that Intra-Cellular already markets lumateperone 42 mg in the United States under the brand name, Caplyta, which is the only marketed drug in the company’s portfolio. Caplyta was initially approved by the FDA in 2019 for the treatment of schizophrenia in adults. Later in 2021, Caplyta’s label was expanded to treat depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
Two other dosage strengths of Caplyta, 10.5 mg and 21 mg capsules, were also approved by the FDA and subsequently launched commercially in 2022 for special populations of patients. These new dosage strengths have expanded the eligible patient population for Caplyta.
Lumateperone was observed to be generally safe and overall well-tolerated in Study 501. Adverse events reported by Intra-Cellular in the study were mostly mild to moderate in severity and were resolved quickly. The safety data of lumateperone seen in Study 501 is consistent with that observed in prior studies of the drug as a treatment for bipolar depression and schizophrenia.
If approved as an adjunctive treatment for MDD, the eligible patient population for Caplyta will be further expanded. This is expected to boost Intra-Cellular’s Caplyta sales, thereby increasing revenues for the company.
MDD is a common, albeit serious mood disorder that causes a persistent feeling of sadness or loss of interest. Approximately 21 million adults suffer from MDD each year in the United States.
A second phase III study, Study 502, is also currently ongoing, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. The top-line data readout from Study 502 is expected later in the second quarter of 2024.
We remind the investors that a third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support a regulatory filing seeking label expansion of the drug for this indication if needed.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 36.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have rallied 46.7%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 46.1%.
ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
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Intra-Cellular (ITCI) Up as Depression Drug Meets Study Goals
Intra-Cellular Therapies, Inc. (ITCI - Free Report) announced positive top-line results from its late-stage study evaluating lumateperone 42 mg for the treatment of major depressive disorder (MDD). The stock climbed 23.3% on Apr 16 following the encouraging news. The stock hit a new 52-week high on Tuesday, driven by the significant pipeline development.
The phase III study, called Study 501, evaluating lumateperone 42 mg given once daily as an adjunctive therapy to antidepressants for MDD, met the primary endpoint. A statistically significant and clinically meaningful reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score was observed compared with placebo at week six.
MADRS is a metric showing the improvement of depressive symptoms in MDD patients compared with placebo after the treatment period.
Intra-Cellular also reported that the key secondary endpoint was also achieved by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale score, which is a measure of severity of illness compared with placebo at week six.
Statistically significant efficacy upon treatment of MDD patients with lumateperone 42 mg was observed as early as after one week of dosing, which was maintained throughout the study in the primary and key secondary endpoints.
Additionally, feedback from MDD patients, as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16), demonstrated that lumateperone 42 mg robustly improved depressive symptoms. The QIDS-SR-16 contains 16 items that evaluate symptom severity in depression as rated by the patients themselves.
The nine key symptoms of depression assessed by the QIDS-SR-16 are insomnia/hypersomnia, low mood, appetite/weight changes, impaired self-perception, concentration difficulties, loss of interest/pleasure, suicidal ideation, psychomotor agitation and fatigue.
Year to date, shares of ITCI have gained 11.5% against the industry’s 8.9% decline.
Image Source: Zacks Investment Research
Please note that Intra-Cellular already markets lumateperone 42 mg in the United States under the brand name, Caplyta, which is the only marketed drug in the company’s portfolio. Caplyta was initially approved by the FDA in 2019 for the treatment of schizophrenia in adults. Later in 2021, Caplyta’s label was expanded to treat depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
Two other dosage strengths of Caplyta, 10.5 mg and 21 mg capsules, were also approved by the FDA and subsequently launched commercially in 2022 for special populations of patients. These new dosage strengths have expanded the eligible patient population for Caplyta.
Lumateperone was observed to be generally safe and overall well-tolerated in Study 501. Adverse events reported by Intra-Cellular in the study were mostly mild to moderate in severity and were resolved quickly. The safety data of lumateperone seen in Study 501 is consistent with that observed in prior studies of the drug as a treatment for bipolar depression and schizophrenia.
If approved as an adjunctive treatment for MDD, the eligible patient population for Caplyta will be further expanded. This is expected to boost Intra-Cellular’s Caplyta sales, thereby increasing revenues for the company.
MDD is a common, albeit serious mood disorder that causes a persistent feeling of sadness or loss of interest. Approximately 21 million adults suffer from MDD each year in the United States.
A second phase III study, Study 502, is also currently ongoing, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. The top-line data readout from Study 502 is expected later in the second quarter of 2024.
We remind the investors that a third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support a regulatory filing seeking label expansion of the drug for this indication if needed.
Intra-Cellular Therapies Inc. Price and Consensus
Intra-Cellular Therapies Inc. price-consensus-chart | Intra-Cellular Therapies Inc. Quote
Zacks Rank & Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Annovis Bio (ANVS - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ANVS 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 ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 36.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have rallied 46.7%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 46.1%.
ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.