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Intra-Cellular (ITCI) Depression Drug Meets Study Goal, Stock Up
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Intra-Cellular Therapies, Inc. (ITCI - Free Report) announced positive top-line results from its phase III Study 403. The study evaluates 42 mg of lumateperone as monotherapy in the treatment of major depressive episodes in patients with major depressive disorder (MDD) with mixed features and patients with bipolar depression with mixed features. The stock of the company was up 16% on Tuesday following the news.
In the past year, shares of Intra-Cellular have declined 7.6% compared with the industry’s 15.9% fall.
Image Source: Zacks Investment Research
In the label-expanding study, once-daily lumateperone 42 mg met its primary endpoint of meaningful reduction in the Montgomery Asberg Depression Rating Scale total score compared with placebo at week six, with statistical significance. The candidate also met the key secondary endpoint of meaningful, statistically significant, reduction in the Global Impression of Severity Scale (CGI-S) score compared with placebo at week six in the combined patient population of MDD with mixed features and bipolar depression with mixed features, patients with MDD with mixed features and patients with bipolar depression with mixed features.
It was observed that lumateperone was generally safe and overall, well tolerated. Side effects were consistent with observations made in previous studies of the candidate. The most common adverse events included somnolence, dizziness and nausea. Per management, the top-line data provide proof of concept in these patient populations validating lumateperone’s broad potential in mood disorders. The company is planning to hold discussions with the FDA regarding these results to determine its step forward.
MDD is a common, albeit serious mood disorder that causes a persistent feeling of sadness or loss of interest. Approximately 21 million adults have been estimated to be suffering from MDD in 2020 in the United States.
It is to be noted that Intra-Cellular first received FDA approval for lumateperone for the treatment of schizophrenia in adults in December 2019. The drug was commercially launched in March 2020 under the brand name Caplyta.
In December 2021, Caplyta was approved by the FDA to treat bipolar depression in adults. Caplyta is currently the only approved treatment, both as monotherapy and as adjunctive therapy with lithium or valproate, for depressive episodes associated with bipolar depression in adults.
Moreover, 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.
However, 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.
In the past 90 days, the estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 56 cents. In the year so far, shares of Aptinyx have fallen by 94.5%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 9.53%.
In the past 90 days, the consensus estimate for Annovis’ 2023 loss per share has narrowed from $2.94 to $2.93. In the year so far, shares of Annovis have increased by 43.6%.
ANVS’ reported loss per share was narrower than the estimated loss per share in the last reported quarter, delivering an earnings surprise of 20.51%.
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Intra-Cellular (ITCI) Depression Drug Meets Study Goal, Stock Up
Intra-Cellular Therapies, Inc. (ITCI - Free Report) announced positive top-line results from its phase III Study 403. The study evaluates 42 mg of lumateperone as monotherapy in the treatment of major depressive episodes in patients with major depressive disorder (MDD) with mixed features and patients with bipolar depression with mixed features. The stock of the company was up 16% on Tuesday following the news.
In the past year, shares of Intra-Cellular have declined 7.6% compared with the industry’s 15.9% fall.
Image Source: Zacks Investment Research
In the label-expanding study, once-daily lumateperone 42 mg met its primary endpoint of meaningful reduction in the Montgomery Asberg Depression Rating Scale total score compared with placebo at week six, with statistical significance. The candidate also met the key secondary endpoint of meaningful, statistically significant, reduction in the Global Impression of Severity Scale (CGI-S) score compared with placebo at week six in the combined patient population of MDD with mixed features and bipolar depression with mixed features, patients with MDD with mixed features and patients with bipolar depression with mixed features.
It was observed that lumateperone was generally safe and overall, well tolerated. Side effects were consistent with observations made in previous studies of the candidate. The most common adverse events included somnolence, dizziness and nausea. Per management, the top-line data provide proof of concept in these patient populations validating lumateperone’s broad potential in mood disorders. The company is planning to hold discussions with the FDA regarding these results to determine its step forward.
MDD is a common, albeit serious mood disorder that causes a persistent feeling of sadness or loss of interest. Approximately 21 million adults have been estimated to be suffering from MDD in 2020 in the United States.
It is to be noted that Intra-Cellular first received FDA approval for lumateperone for the treatment of schizophrenia in adults in December 2019. The drug was commercially launched in March 2020 under the brand name Caplyta.
In December 2021, Caplyta was approved by the FDA to treat bipolar depression in adults. Caplyta is currently the only approved treatment, both as monotherapy and as adjunctive therapy with lithium or valproate, for depressive episodes associated with bipolar depression in adults.
Moreover, 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.
However, 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.
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).
Some better-ranked stocks in the same industry are Aptinyx and Annovis Bio (ANVS - 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 estimate for Aptinyx’s 2023 loss per share has narrowed from 77 cents to 56 cents. In the year so far, shares of Aptinyx have fallen by 94.5%.
APTX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 9.53%.
In the past 90 days, the consensus estimate for Annovis’ 2023 loss per share has narrowed from $2.94 to $2.93. In the year so far, shares of Annovis have increased by 43.6%.
ANVS’ reported loss per share was narrower than the estimated loss per share in the last reported quarter, delivering an earnings surprise of 20.51%.