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FDA Accepts Karuna's (KRTX) NDA Filing for Schizophrenia Drug
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Karuna Therapeutics announced that the FDA accepted the new drug application (NDA), with the FDA seeking approval for its lead candidate, KarXT, as a potential treatment of schizophrenia in adults. A final decision is expected by Sep 26, 2024.
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 before 2024-end.
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.
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.
Year to date, shares of Karuna have lost 4.0% compared with the industry’s 23.8% decline.
Image Source: Zacks Investment Research
Earlier this month, management reported positive results from a phase Ib study evaluating KarXT on 24-hour ambulatory blood pressure in adults with schizophrenia. Data from the study showed that KarXT was not associated with sustained increases in blood pressure in schizophrenia patients.
The phase Ib study results further substantiate the existing clinical data from the EMERGENT program, providing more definitive proof of the cardiovascular safety profile of KarXT in treating schizophrenia. Management had previously intended to submit these results to the FDA as part of a 120-day safety update to the above NDA.
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 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 CytomX Therapeutics’ 2023 loss per share have improved from 37 cents to 6 cents. During the same period, the loss estimates per share for 2024 have narrowed from 51 cents to 21 cents. Shares of CytomX have lost 16.9% in the year-to-date period.
CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share (EPS) have increased from $2.22 to $2.62. During the same period, the earnings estimates per share for 2024 have risen from $2.57 to $3.07. Shares of NVO have surged 50.7% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 EPS have increased from 67 cents to 73 cents. During the same period, the earnings estimates per share for 2024 have risen from 55 cents to 62 cents. Shares of PBYI have lost 8.3% in the year-to-date period.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average surprise of 76.55%. In the last reported quarter, Puma Biotechnology’s earnings beat estimates by 13.33%.
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FDA Accepts Karuna's (KRTX) NDA Filing for Schizophrenia Drug
Karuna Therapeutics announced that the FDA accepted the new drug application (NDA), with the FDA seeking approval for its lead candidate, KarXT, as a potential treatment of schizophrenia in adults. A final decision is expected by Sep 26, 2024.
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 before 2024-end.
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.
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.
Year to date, shares of Karuna have lost 4.0% compared with the industry’s 23.8% decline.
Image Source: Zacks Investment Research
Earlier this month, management reported positive results from a phase Ib study evaluating KarXT on 24-hour ambulatory blood pressure in adults with schizophrenia. Data from the study showed that KarXT was not associated with sustained increases in blood pressure in schizophrenia patients.
The phase Ib study results further substantiate the existing clinical data from the EMERGENT program, providing more definitive proof of the cardiovascular safety profile of KarXT in treating schizophrenia. Management had previously intended to submit these results to the FDA as part of a 120-day safety update to the above NDA.
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 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). Some better-ranked stocks in the overall healthcare sector include CytomX Therapeutics (CTMX - Free Report) , Novo Nordisk (NVO - Free Report) and Puma Biotechnology (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have improved from 37 cents to 6 cents. During the same period, the loss estimates per share for 2024 have narrowed from 51 cents to 21 cents. Shares of CytomX have lost 16.9% in the year-to-date period.
CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share (EPS) have increased from $2.22 to $2.62. During the same period, the earnings estimates per share for 2024 have risen from $2.57 to $3.07. Shares of NVO have surged 50.7% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 EPS have increased from 67 cents to 73 cents. During the same period, the earnings estimates per share for 2024 have risen from 55 cents to 62 cents. Shares of PBYI have lost 8.3% in the year-to-date period.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average surprise of 76.55%. In the last reported quarter, Puma Biotechnology’s earnings beat estimates by 13.33%.