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Intra-Cellular's (ITCI) Caplyta Aids Sales, Overreliance a Woe
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Intra-Cellular Therapies (ITCI - Free Report) , a biopharmaceutical company, is focused on discovering, developing and commercializing small-molecule drugs for treating neuropsychiatric and neurological disorders.
Intra-Cellular’s only marketed drug, Caplyta (lumateperone), was approved by the FDA in December 2019, for the treatment of schizophrenia in adults. The drug was commercially launched in the United States in March 2020 and quickly gained traction in the market. In December 2021, Caplyta was also approved for depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
In April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg, for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
Post these approvals, Caplyta’s sales skyrocketed, clocking growth of 243% year over year at $87.4 million in the last reported quarter from the year-ago quarter’s reported figure. Per management, Caplyta’s total and new prescriptions increased by 193% and 220%, respectively, year over year in the reported quarter from the year-ago quarter’s levels. Net product sales of Caplyta as of December end, were $249.1 million, up 205% year over year.
In the past year, shares of Intra-Cellular have gained 16% against the industry’s 8.2% decline.
Image Source: Zacks Investment Research
Intra-Cellular is also evaluating Caplyta in several other indications.Currently, the company is evaluating lumateperone in several label-expanding late-stage studies. The company is currently enrolling patients in its global phase III studies 501 and 502, evaluating 42 mg of lumateperone as a treatment for major depressive disorder (MDD). Intra-Cellular intends to file a supplemental new drug application seeking approval for lumateperone as adjunctive therapy to antidepressants for the treatment of MDD with the FDA in 2024.
In March 2023, Intra-Cellular announced positive top-line results from another label-expanding study on lumateperone. The phase III Study 403 evaluated 42 mg of lumateperone as monotherapy in the treatment of major depressive episodes,associated withbipolar I and bipolar II disorder, in patients with MDD with mixed features and patients with bipolar depression with mixed features. The study met both its primary and key secondary endpoints with statistical significance compared with treatment with placebo. These data provide proof of concept in the patient populations of the study, validating lumateperone’s broad potential in mood disorders. The company plans to discuss these results with the FDA to determine its step forward.
A potential approval is anticipated to boost Intra-Cellular’s top line.
Intra-Cellular is also developing a deuterated form of lumateperone, ITI-1248-ODT-SL, for treating behavioral disturbance in dementia patients, dementia-related psychosis and certain depressive disorders in the elderly. phase I single and multiple ascending dose studies have been completed. Based on these results, Intra-Cellular expects to begin phase II clinical studies in agitation in patients with probable Alzheimer’s disease, dementia-related psychosis and certain depressive disorders in the elderly in 2023.
Additionally, Intra-Cellular is working on long-acting injectable formulations in patients with stable symptoms of schizophrenia.
Despite label-expansion efforts, Intra-Cellular’s high dependence on just Caplyta sales for revenues is a concern. It needs growth opportunities apart from Caplyta.
Other than Caplyta, Intra-Cellular also has other pipeline candidates in early-stage studies. Lenrispodun (ITI-214) is being developed for Parkinson’s disease and ITI-333 is being developed as a potential treatment for substance use disorders, pain and psychiatric comorbidities, including depression and anxiety. ITI-1020 is being developed as a novel cancer immunotherapy and falls under Intra-Cellular’s PDE 1 program. However, all these are several years away from commercialization.
Competition also remains a concern for Intra-Cellular Therapies. Upon lumateperone’s approval for the treatment of MDD, Intra-Cellular is bound to face stiff competition from Axsome Therapeutics (AXSM - Free Report) . In August 2022, Axsome received FDA approval for its lead pipeline candidate AXS-05, with the trade name of Auvelity, for the treatment of adults with MDD, making it the first approved drug in its portfolio. Axsome launched Auvelity as an MDD therapy in the United States in October 2022. Axsome’s AXS-05 is also currently being evaluated for several CNS disorders.
Nonetheless, a consistent increase in Caplyta sales, successful label expansion of the drug and relatively less competition in its target market are likely to keep the stock afloat in the long term.
In the past 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 47 cents. In the past year, shares of Aptinyx have fallen by 86.8%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals’ 2023 loss per share has narrowed from 87 cents to 57 cents. In the past year, shares of Acadia Pharmaceuticals have fallen by 2.2%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average negative earnings surprise of 6.33%.
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Intra-Cellular's (ITCI) Caplyta Aids Sales, Overreliance a Woe
Intra-Cellular Therapies (ITCI - Free Report) , a biopharmaceutical company, is focused on discovering, developing and commercializing small-molecule drugs for treating neuropsychiatric and neurological disorders.
Intra-Cellular’s only marketed drug, Caplyta (lumateperone), was approved by the FDA in December 2019, for the treatment of schizophrenia in adults. The drug was commercially launched in the United States in March 2020 and quickly gained traction in the market. In December 2021, Caplyta was also approved for depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
In April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg, for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
Post these approvals, Caplyta’s sales skyrocketed, clocking growth of 243% year over year at $87.4 million in the last reported quarter from the year-ago quarter’s reported figure. Per management, Caplyta’s total and new prescriptions increased by 193% and 220%, respectively, year over year in the reported quarter from the year-ago quarter’s levels. Net product sales of Caplyta as of December end, were $249.1 million, up 205% year over year.
In the past year, shares of Intra-Cellular have gained 16% against the industry’s 8.2% decline.
Image Source: Zacks Investment Research
Intra-Cellular is also evaluating Caplyta in several other indications.Currently, the company is evaluating lumateperone in several label-expanding late-stage studies. The company is currently enrolling patients in its global phase III studies 501 and 502, evaluating 42 mg of lumateperone as a treatment for major depressive disorder (MDD). Intra-Cellular intends to file a supplemental new drug application seeking approval for lumateperone as adjunctive therapy to antidepressants for the treatment of MDD with the FDA in 2024.
In March 2023, Intra-Cellular announced positive top-line results from another label-expanding study on lumateperone. The phase III Study 403 evaluated 42 mg of lumateperone as monotherapy in the treatment of major depressive episodes,associated withbipolar I and bipolar II disorder, in patients with MDD with mixed features and patients with bipolar depression with mixed features. The study met both its primary and key secondary endpoints with statistical significance compared with treatment with placebo. These data provide proof of concept in the patient populations of the study, validating lumateperone’s broad potential in mood disorders. The company plans to discuss these results with the FDA to determine its step forward.
A potential approval is anticipated to boost Intra-Cellular’s top line.
Intra-Cellular is also developing a deuterated form of lumateperone, ITI-1248-ODT-SL, for treating behavioral disturbance in dementia patients, dementia-related psychosis and certain depressive disorders in the elderly. phase I single and multiple ascending dose studies have been completed. Based on these results, Intra-Cellular expects to begin phase II clinical studies in agitation in patients with probable Alzheimer’s disease, dementia-related psychosis and certain depressive disorders in the elderly in 2023.
Additionally, Intra-Cellular is working on long-acting injectable formulations in patients with stable symptoms of schizophrenia.
Despite label-expansion efforts, Intra-Cellular’s high dependence on just Caplyta sales for revenues is a concern. It needs growth opportunities apart from Caplyta.
Other than Caplyta, Intra-Cellular also has other pipeline candidates in early-stage studies. Lenrispodun (ITI-214) is being developed for Parkinson’s disease and ITI-333 is being developed as a potential treatment for substance use disorders, pain and psychiatric comorbidities, including depression and anxiety. ITI-1020 is being developed as a novel cancer immunotherapy and falls under Intra-Cellular’s PDE 1 program. However, all these are several years away from commercialization.
Competition also remains a concern for Intra-Cellular Therapies. Upon lumateperone’s approval for the treatment of MDD, Intra-Cellular is bound to face stiff competition from Axsome Therapeutics (AXSM - Free Report) . In August 2022, Axsome received FDA approval for its lead pipeline candidate AXS-05, with the trade name of Auvelity, for the treatment of adults with MDD, making it the first approved drug in its portfolio. Axsome launched Auvelity as an MDD therapy in the United States in October 2022. Axsome’s AXS-05 is also currently being evaluated for several CNS disorders.
Nonetheless, a consistent increase in Caplyta sales, successful label expansion of the drug and relatively less competition in its target market are likely to keep the stock afloat in the long term.
Intra-Cellular Therapies Inc. Price and Consensus
Intra-Cellular Therapies Inc. price-consensus-chart | Intra-Cellular Therapies Inc. Quote
Zacks Rank and Stocks to Consider
Intra-Cellular currently has a Zacks Rank #3 (Hold).
A couple of top-ranked stocks in the same industry are Aptinyx and Acadia Pharmaceuticals (ACAD - Free Report) , both 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 90 days, the Zacks Consensus Estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 47 cents. In the past year, shares of Aptinyx have fallen by 86.8%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 6.56%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals’ 2023 loss per share has narrowed from 87 cents to 57 cents. In the past year, shares of Acadia Pharmaceuticals have fallen by 2.2%.
ACAD beat estimates in two of the trailing four quarters, missing the mark on other two occasions, delivering an average negative earnings surprise of 6.33%.