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Minerva (NERV) Soars on Promising Schizophrenia Study Data
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Minerva Neurosciences, Inc. (NERV - Free Report) announced positive data from the open-label extension (“OLE”) of its previously completed phase III study evaluating its lead pipeline candidate, roluperidone, as a potential treatment for negative symptoms of schizophrenia.
Combined data from the 12-week phase III study and 40-week OLE study demonstrated that treatment with both doses of roluperidone — 32mg and 64mg — administered without concomitant treatment with antipsychotics has the potential to consistently reduce overall negative symptoms and result in functional improvement over the long term.
The company stated that data from the OLE study supported continued development of roluperidone for treating negative symptoms of schizophrenia. Moreover, the data is also deemed to supported a new drug application (“NDA”) to the FDA following completion of a bioequivalence study and to address FDA’s comments during a Type C meeting held in November last year. Please note that roluperidone failed to meet its primary endpoint in the 12-week phase III study evaluating it to treat negative symptoms in schizophrenia last year. However, the FDA advised to continue development of the candidate during the meeting in November based on promising signals of the treatment in a field with unmet need.
Investors cheered the news as shares of Minerva soared almost 34.5% during after-hours trading on May 11, following the announcement. However, the company’s shares have declined 4.7% so far this year compared with the industry’s 11.6% decrease.
Minerva has now completed a phase IIb study, a phase III study and the OLE of the phase III study, evaluating both doses of roluperidone for treating negative symptoms of schizophrenia. The FDA previously noted that the mid-stage study did not evaluate the commercial formulation of roluperidone and was conducted solely outside of the United States. Hence, data from the mid-stage study along with the failed late-stage study were insufficient to support an NDA.
The company conducted the OLE study to gather additional data in support of the candidate’s potential to improve patient condition. Data from the OLE showed that mean improvement in negative symptoms over the 40 weeks of treatment was 6.8 points in the 32 mg arm and 7.5 points in the 64 mg arm, as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS). Treatment with roluperidone also improved Personal and Social Performance (PSP) total score, a scale to measure functional improvement, by a mean of 12.3 points and 14.5 points in the 32 mg and 64 mg arms, respectively.
Meanwhile, the company is planning to initiate a pivotal bioequivalence study to bridge the two formulations used in the phase IIb and phase III studies as well as at least one commercial formulation that it plans to develop with its commercial supply partner, Catalent (CTLT - Free Report) . The company believes that data from bioequivalence study and previously completed studies will be sufficient to support an NDA for roluperidone as treatment for negative symptoms of schizophrenia.
Xencor’s loss per share estimates have narrowed from $2.38 to $1.57 for 2021 and from $3.35 to $2.94 over the past 30 days. The company delivered an earnings surprise of 35.36%, on average, in the last four quarters.
Ironwood’s earnings estimates have been revised upward from 87 cents to 96 cents for 2021 and from $1.01 to $1.11 over the past 30 days. The company delivered an earnings surprise of 51.68%, on average, in the last four quarters.
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Minerva (NERV) Soars on Promising Schizophrenia Study Data
Minerva Neurosciences, Inc. (NERV - Free Report) announced positive data from the open-label extension (“OLE”) of its previously completed phase III study evaluating its lead pipeline candidate, roluperidone, as a potential treatment for negative symptoms of schizophrenia.
Combined data from the 12-week phase III study and 40-week OLE study demonstrated that treatment with both doses of roluperidone — 32mg and 64mg — administered without concomitant treatment with antipsychotics has the potential to consistently reduce overall negative symptoms and result in functional improvement over the long term.
The company stated that data from the OLE study supported continued development of roluperidone for treating negative symptoms of schizophrenia. Moreover, the data is also deemed to supported a new drug application (“NDA”) to the FDA following completion of a bioequivalence study and to address FDA’s comments during a Type C meeting held in November last year. Please note that roluperidone failed to meet its primary endpoint in the 12-week phase III study evaluating it to treat negative symptoms in schizophrenia last year. However, the FDA advised to continue development of the candidate during the meeting in November based on promising signals of the treatment in a field with unmet need.
Investors cheered the news as shares of Minerva soared almost 34.5% during after-hours trading on May 11, following the announcement. However, the company’s shares have declined 4.7% so far this year compared with the industry’s 11.6% decrease.
Minerva has now completed a phase IIb study, a phase III study and the OLE of the phase III study, evaluating both doses of roluperidone for treating negative symptoms of schizophrenia. The FDA previously noted that the mid-stage study did not evaluate the commercial formulation of roluperidone and was conducted solely outside of the United States. Hence, data from the mid-stage study along with the failed late-stage study were insufficient to support an NDA.
The company conducted the OLE study to gather additional data in support of the candidate’s potential to improve patient condition. Data from the OLE showed that mean improvement in negative symptoms over the 40 weeks of treatment was 6.8 points in the 32 mg arm and 7.5 points in the 64 mg arm, as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS). Treatment with roluperidone also improved Personal and Social Performance (PSP) total score, a scale to measure functional improvement, by a mean of 12.3 points and 14.5 points in the 32 mg and 64 mg arms, respectively.
Meanwhile, the company is planning to initiate a pivotal bioequivalence study to bridge the two formulations used in the phase IIb and phase III studies as well as at least one commercial formulation that it plans to develop with its commercial supply partner, Catalent (CTLT - Free Report) . The company believes that data from bioequivalence study and previously completed studies will be sufficient to support an NDA for roluperidone as treatment for negative symptoms of schizophrenia.
Minerva Neurosciences, Inc Price
Minerva Neurosciences, Inc price | Minerva Neurosciences, Inc Quote
Zacks Rank & Stocks to Consider
Currently, Minerva carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the drug sector include Xencor, Inc. (XNCR - Free Report) and Ironwood Pharmaceuticals, Inc. (IRWD - 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.
Xencor’s loss per share estimates have narrowed from $2.38 to $1.57 for 2021 and from $3.35 to $2.94 over the past 30 days. The company delivered an earnings surprise of 35.36%, on average, in the last four quarters.
Ironwood’s earnings estimates have been revised upward from 87 cents to 96 cents for 2021 and from $1.01 to $1.11 over the past 30 days. The company delivered an earnings surprise of 51.68%, on average, in the last four quarters.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
AccessZacks Top 10 Stocks for 2021 today >>