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Karuna's (KRTX) KarXT Meets Primary Goal in Schizophrenia Study
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Karuna Therapeutics announced positive top line data from the phase III EMERGENT-3 study, which evaluated the efficacy, safety and tolerability of its lead pipeline candidate, KarXT (xanomeline-trospium), in adults with schizophrenia.
KarXT exhibited a statistically significant and clinically meaningful 8.4-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score over placebo at week five, meeting the study’s primary endpoint. PANSS is a scale for measuring schizophrenia symptom severity. The drug’s safety profile was also consistent with previously conducted clinical studies.
The EMERGENT-3 study also showed that treatment with KarXT demonstrated reductions in both positive symptoms (like hallucinations or delusions) and negative symptoms (like, difficulty enjoying life or withdrawal from others) of schizophrenia, the secondary endpoints of the study. While treatment with the drug did achieve a statistically significant reduction in the positive symptoms, it did not meet the threshold for statistical significance in negative symptoms.
Though Karuna’s stock initially rose in the pre-market on Mar 20 following the news, shares were down 4.8% in active trading hours, likely as the EMERGENT-3 study did not achieve all of its secondary endpoints. In the year so far, shares have declined 7.1% against the industry’s fall of 7.2%.
Image Source: Zacks Investment Research
The EMERGENT-3 study is a part of the broader EMERGENT clinical program, which is evaluating KarXT for treating acute psychosis in adults with schizophrenia. The program also consists of one completed phase II study (EMERGENT-1), one completed phase III study (EMERGENT-2) and two ongoing late-stage studies, namely EMERGENT-4 and EMERGENT-5, evaluating the efficacy and long-term safety of KarXT in adults with schizophrenia.
Per management, overall data from the EMERGENT program has shown that treatment with Kar-XT addresses schizophrenia symptoms without the common side effects associated with the current treatment options. The company will discuss data from the EMERGENT program with the FDA in the upcoming pre-NDA meeting in second-quarter 2023 for a planned new drug application (NDA) filing for KarXT as a treatment for schizophrenia in mid-2023.
Apart from schizophrenia, Karuna Therapeutics is developing KarXT as a potential treatment for dementia-related psychosis (DRP). The company initially focuses on developing KarXT for the treatment of psychosis in AD, one of the most prevalent subtypes of DRP as a part of the ADEPT clinical program. The company started the phase III ADEPT-1 study in third-quarter 2022, which is evaluating KarXT for psychosis in elderly patients with moderate to severe psychosis related to AD. Two more studies – ADEPT-2 and ADEPT-3 – are expected to start later this year.
Estimates for Adaptive Biotechnologies’ 2023 loss per share narrowed from $1.20 to $1.15 in the past 30 days. During the same period, the loss per share estimates for 2024 narrowed from 99 cents to 94 cents. Shares of Adaptive Biotechnologies have risen 5.1% year-to-date.
Earnings of Adaptive Biotechnologies beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 10.75%. In the last reported quarter, ADPT delivered an earnings surprise of 24.32%.
In the past 30 days, estimates for Atara Biotherapeutics’ 2023 loss per share narrowed from $2.28 to $2.17. During the same period, the loss per share estimates for 2024 narrowed from $1.81 to $1.62. Shares of Atara Biotherapeutics have declined 9.2% in the year-to-date period.
Earnings of Atara Biotherapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 13.50%, on average. In the last reported quarter, Atara Biotherapeutics’ earnings missed estimates by 18.03%.
In the past 30 days, estimates for AVITA Medical’s 2023 loss per share narrowed from $1.26 to 99 cents. During the same period, the loss per share estimates for 2024 narrowed from 92 cents to 79 cents. In the year so far, shares of AVITA Medical have surged 100.2%.
Earnings of AVITA Medical beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 22.16%, on average. In the last reported quarter, AVITA Medical’s earnings beat estimates by 34.38%.
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Karuna's (KRTX) KarXT Meets Primary Goal in Schizophrenia Study
Karuna Therapeutics announced positive top line data from the phase III EMERGENT-3 study, which evaluated the efficacy, safety and tolerability of its lead pipeline candidate, KarXT (xanomeline-trospium), in adults with schizophrenia.
KarXT exhibited a statistically significant and clinically meaningful 8.4-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score over placebo at week five, meeting the study’s primary endpoint. PANSS is a scale for measuring schizophrenia symptom severity. The drug’s safety profile was also consistent with previously conducted clinical studies.
The EMERGENT-3 study also showed that treatment with KarXT demonstrated reductions in both positive symptoms (like hallucinations or delusions) and negative symptoms (like, difficulty enjoying life or withdrawal from others) of schizophrenia, the secondary endpoints of the study. While treatment with the drug did achieve a statistically significant reduction in the positive symptoms, it did not meet the threshold for statistical significance in negative symptoms.
Though Karuna’s stock initially rose in the pre-market on Mar 20 following the news, shares were down 4.8% in active trading hours, likely as the EMERGENT-3 study did not achieve all of its secondary endpoints. In the year so far, shares have declined 7.1% against the industry’s fall of 7.2%.
Image Source: Zacks Investment Research
The EMERGENT-3 study is a part of the broader EMERGENT clinical program, which is evaluating KarXT for treating acute psychosis in adults with schizophrenia. The program also consists of one completed phase II study (EMERGENT-1), one completed phase III study (EMERGENT-2) and two ongoing late-stage studies, namely EMERGENT-4 and EMERGENT-5, evaluating the efficacy and long-term safety of KarXT in adults with schizophrenia.
Per management, overall data from the EMERGENT program has shown that treatment with Kar-XT addresses schizophrenia symptoms without the common side effects associated with the current treatment options. The company will discuss data from the EMERGENT program with the FDA in the upcoming pre-NDA meeting in second-quarter 2023 for a planned new drug application (NDA) filing for KarXT as a treatment for schizophrenia in mid-2023.
Apart from schizophrenia, Karuna Therapeutics is developing KarXT as a potential treatment for dementia-related psychosis (DRP). The company initially focuses on developing KarXT for the treatment of psychosis in AD, one of the most prevalent subtypes of DRP as a part of the ADEPT clinical program. The company started the phase III ADEPT-1 study in third-quarter 2022, which is evaluating KarXT for psychosis in elderly patients with moderate to severe psychosis related to AD. Two more studies – ADEPT-2 and ADEPT-3 – are expected to start later this year.
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 Adaptive Biotechnologies Corporation (ADPT - Free Report) , Atara Biotherapeutics (ATRA - Free Report) and AVITA Medical (RCEL - 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.
Estimates for Adaptive Biotechnologies’ 2023 loss per share narrowed from $1.20 to $1.15 in the past 30 days. During the same period, the loss per share estimates for 2024 narrowed from 99 cents to 94 cents. Shares of Adaptive Biotechnologies have risen 5.1% year-to-date.
Earnings of Adaptive Biotechnologies beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 10.75%. In the last reported quarter, ADPT delivered an earnings surprise of 24.32%.
In the past 30 days, estimates for Atara Biotherapeutics’ 2023 loss per share narrowed from $2.28 to $2.17. During the same period, the loss per share estimates for 2024 narrowed from $1.81 to $1.62. Shares of Atara Biotherapeutics have declined 9.2% in the year-to-date period.
Earnings of Atara Biotherapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 13.50%, on average. In the last reported quarter, Atara Biotherapeutics’ earnings missed estimates by 18.03%.
In the past 30 days, estimates for AVITA Medical’s 2023 loss per share narrowed from $1.26 to 99 cents. During the same period, the loss per share estimates for 2024 narrowed from 92 cents to 79 cents. In the year so far, shares of AVITA Medical have surged 100.2%.
Earnings of AVITA Medical beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 22.16%, on average. In the last reported quarter, AVITA Medical’s earnings beat estimates by 34.38%.