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Karuna (KRTX) Submits NDA Filing to FDA for Schizophrenia Drug
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Karuna Therapeutics announced the submission of a new drug application (“NDA”) with the FDA seeking approval for its lead candidate KarXT, as a potential treatment of schizophrenia.
If approved, Karuna’s KarXT will provide a new treatment option for patients and be the first novel pharmacological approach for schizophrenia treatment in several decades. A commercial launch is expected in second-half 2024.
The NDA is supported by data from the EMERGENT program, which consists of three completed studies –- one phase II study (EMERGENT-1) and two phase III studies (EMERGENT-2 and EMERGENT-3). All three studies met their primary endpointof statistically significant and clinically meaningful reduction in the total score of the Positive and Negative Syndrome Scale (“PANSS”). PANSS is a scale for measuring schizophrenia symptom severity. The drug’s safety profile was also consistent with previously conducted clinical studies.
Data from the EMERGENT program has shown that treatment with Kar-XT addresses schizophrenia symptoms without the common side effects of current treatment options.
Karuna is currently evaluating the long-term safety of KarXT in two ongoing phase III studies –- EMERGENT-4 and EMERGENT-5.
Year to date, shares of Karuna have lost 13.4% compared with the industry’s 16.1% decline.
Image Source: Zacks Investment Research
Schizophrenia is a mental disorder characterized by recurring episodes of psychosis and requiring long-term treatments with antipsychotic drugs. While the current standard-of-care antipsychotic treatments primarily work by inhibiting dopamine and serotonin receptors, they also carry many debilitating side effects. KarXT works by preferentially stimulating M1 and M4 muscarinic receptors in CNS. A stimulation in these receptors has demonstrated improvements in psychosis and cognition.
Apart from schizophrenia, Karuna Therapeutics is developing KarXT as a potential treatment for dementia-related psychosis (DRP). The company initially focused on developing KarXT for treating psychosis in Alzheimer’s disease (“AD”), one of the most prevalent subtypes of DRP, as a part of the ADEPT clinical program. Two studies in the ADEPT program are ongoing, with a third study expected to start before this year’s end. Top-line data from these studies are expected by 2025.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 30.2%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 60 days, estimates for Compugen’s 2023 earnings per share narrowed from 35 cents to 34 cents. During the same period, the loss estimates per share for 2024 have improved from 47 cents to 43 cents. Year to date, shares of Compugen have risen 23.0%.
Earnings of Compugen beat estimates in three of the trailing four quarters while missing the mark on one occasion, witnessing an average earnings surprise of 21.86%. In the last reported quarter, Compugen’s earnings beat estimates by 15.38%.
In the past 60 days, estimates for Vaxxinity’s 2023 earnings per share narrowed from 69 cents to 58 cents. During the same period, the loss estimates per share for 2024 have improved from 70 cents to 54 cents. Year to date, shares of Vaxxinity have registered breakeven growth.
Earnings of Vaxxinity beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 10.94%. In the last reported quarter, Vaxxinity’s earnings beat estimates by 31.25%.
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Karuna (KRTX) Submits NDA Filing to FDA for Schizophrenia Drug
Karuna Therapeutics announced the submission of a new drug application (“NDA”) with the FDA seeking approval for its lead candidate KarXT, as a potential treatment of schizophrenia.
If approved, Karuna’s KarXT will provide a new treatment option for patients and be the first novel pharmacological approach for schizophrenia treatment in several decades. A commercial launch is expected in second-half 2024.
The NDA is supported by data from the EMERGENT program, which consists of three completed studies –- one phase II study (EMERGENT-1) and two phase III studies (EMERGENT-2 and EMERGENT-3). All three studies met their primary endpointof statistically significant and clinically meaningful reduction in the total score of the Positive and Negative Syndrome Scale (“PANSS”). PANSS is a scale for measuring schizophrenia symptom severity. The drug’s safety profile was also consistent with previously conducted clinical studies.
Data from the EMERGENT program has shown that treatment with Kar-XT addresses schizophrenia symptoms without the common side effects of current treatment options.
Karuna is currently evaluating the long-term safety of KarXT in two ongoing phase III studies –- EMERGENT-4 and EMERGENT-5.
Year to date, shares of Karuna have lost 13.4% compared with the industry’s 16.1% decline.
Image Source: Zacks Investment Research
Schizophrenia is a mental disorder characterized by recurring episodes of psychosis and requiring long-term treatments with antipsychotic drugs. While the current standard-of-care antipsychotic treatments primarily work by inhibiting dopamine and serotonin receptors, they also carry many debilitating side effects. KarXT works by preferentially stimulating M1 and M4 muscarinic receptors in CNS. A stimulation in these receptors has demonstrated improvements in psychosis and cognition.
Apart from schizophrenia, Karuna Therapeutics is developing KarXT as a potential treatment for dementia-related psychosis (DRP). The company initially focused on developing KarXT for treating psychosis in Alzheimer’s disease (“AD”), one of the most prevalent subtypes of DRP, as a part of the ADEPT clinical program. Two studies in the ADEPT program are ongoing, with a third study expected to start before this year’s end. Top-line data from these studies are expected by 2025.
Karuna Therapeutics, Inc. Price
Karuna Therapeutics, Inc. price | Karuna Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Karuna currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks are Annovis Bio (ANVS - Free Report) , Compugen (CGEN - Free Report) and Vaxxinity (VAXX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 30.2%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 60 days, estimates for Compugen’s 2023 earnings per share narrowed from 35 cents to 34 cents. During the same period, the loss estimates per share for 2024 have improved from 47 cents to 43 cents. Year to date, shares of Compugen have risen 23.0%.
Earnings of Compugen beat estimates in three of the trailing four quarters while missing the mark on one occasion, witnessing an average earnings surprise of 21.86%. In the last reported quarter, Compugen’s earnings beat estimates by 15.38%.
In the past 60 days, estimates for Vaxxinity’s 2023 earnings per share narrowed from 69 cents to 58 cents. During the same period, the loss estimates per share for 2024 have improved from 70 cents to 54 cents. Year to date, shares of Vaxxinity have registered breakeven growth.
Earnings of Vaxxinity beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 10.94%. In the last reported quarter, Vaxxinity’s earnings beat estimates by 31.25%.