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Neurocrine Stock Down 19% on Mixed Schizophrenia Study Results
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Shares of Neurocrine Biosciences (NBIX - Free Report) were down nearly 19% on Tuesday after it reported top-line data from a phase II study on its investigational oral drug NBI-1117568 (NBI-'568) in adults with schizophrenia. The drug is being developed in partnership with Nxera Pharma (formerly Sosei Heptares).
NBIX Reports Mixed Results
The study met its primary endpoint — treatment with a 20 mg dose of NBI-'568 achieved a statistically significant and clinically meaningful 7.5-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score over placebo at week six. PANSS is a scale for measuring schizophrenia symptom severity.
Though treatment with three other doses of the drug (30 mg, 40 mg and 60 mg) also achieved a reduction in PANSS scores ranging from 1.9 to 5.0 over placebo, they were not statistically significant. Treatment with the drug was safe and well-tolerated at all doses.
Comparison With Peers
However, Wall Street was not impressed with these results. Multiple analysts pointed out that the data did not match up with the previously-reported results on Bristol Myers’ (BMY - Free Report) KarXT and AbbVie’s (ABBV - Free Report) emraclidine. Both these candidates were recently added by these two pharma giants in multi-billion dollar deals — Bristol Myers bought Karuna Therapeutics in March, while AbbVie announced the completion of the acquisition of Cerevel Therapeutics earlier this month.
An FDA filing on Bristol Myers’ KarXT is currently under review, seeking approval as a potential treatment of schizophrenia in adults. A final decision is expected before Sep. 26. This filing is supported by data from the late-stage EMERGENT-3 study, which showed that treatment with KarXT achieved an 8.4-point reduction in PANSS score over placebo at week five.
Based on data from a mid-stage study reported in 2021, treatment with AbbVie’s emraclidine achieved a 12.7-point reduction at the 20mg dose and an 11.1-point reduction at the 30mg dose.
Year to date, Neurocrine’s stock has lost 6.1% compared with the industry’s 0.7% fall.
Image Source: Zacks Investment Research
NBIX’s Future Plans for the Drug
Despite mixed results, Neurocrine intends to move forward with advancing NBI-'568. Management plans to start a phase III study evaluating the 20mg dose of the drug by early next year.
Apart from schizophrenia, management also plans to evaluate the drug in other indications like Alzheimer's disease, bipolar disorder, lewy body dementia and Parkinson's disease.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, Fulcrum Therapeutics’ shares have rallied 31.4%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.
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Neurocrine Stock Down 19% on Mixed Schizophrenia Study Results
Shares of Neurocrine Biosciences (NBIX - Free Report) were down nearly 19% on Tuesday after it reported top-line data from a phase II study on its investigational oral drug NBI-1117568 (NBI-'568) in adults with schizophrenia. The drug is being developed in partnership with Nxera Pharma (formerly Sosei Heptares).
NBIX Reports Mixed Results
The study met its primary endpoint — treatment with a 20 mg dose of NBI-'568 achieved a statistically significant and clinically meaningful 7.5-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score over placebo at week six. PANSS is a scale for measuring schizophrenia symptom severity.
Though treatment with three other doses of the drug (30 mg, 40 mg and 60 mg) also achieved a reduction in PANSS scores ranging from 1.9 to 5.0 over placebo, they were not statistically significant. Treatment with the drug was safe and well-tolerated at all doses.
Comparison With Peers
However, Wall Street was not impressed with these results. Multiple analysts pointed out that the data did not match up with the previously-reported results on Bristol Myers’ (BMY - Free Report) KarXT and AbbVie’s (ABBV - Free Report) emraclidine. Both these candidates were recently added by these two pharma giants in multi-billion dollar deals — Bristol Myers bought Karuna Therapeutics in March, while AbbVie announced the completion of the acquisition of Cerevel Therapeutics earlier this month.
An FDA filing on Bristol Myers’ KarXT is currently under review, seeking approval as a potential treatment of schizophrenia in adults. A final decision is expected before Sep. 26. This filing is supported by data from the late-stage EMERGENT-3 study, which showed that treatment with KarXT achieved an 8.4-point reduction in PANSS score over placebo at week five.
Based on data from a mid-stage study reported in 2021, treatment with AbbVie’s emraclidine achieved a 12.7-point reduction at the 20mg dose and an 11.1-point reduction at the 30mg dose.
Year to date, Neurocrine’s stock has lost 6.1% compared with the industry’s 0.7% fall.
Image Source: Zacks Investment Research
NBIX’s Future Plans for the Drug
Despite mixed results, Neurocrine intends to move forward with advancing NBI-'568. Management plans to start a phase III study evaluating the 20mg dose of the drug by early next year.
Apart from schizophrenia, management also plans to evaluate the drug in other indications like Alzheimer's disease, bipolar disorder, lewy body dementia and Parkinson's disease.
Neurocrine Biosciences, Inc. Price
Neurocrine Biosciences, Inc. price | Neurocrine Biosciences, Inc. Quote
NBIX Zacks Rank & A Key Pick
Neurocrine carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall biotech sector is Fulcrum Therapeutics (FULC - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have improved from $1.24 to 48 cents. Estimates for 2025 have improved from $1.71 to $1.51 during the same period. Year to date, Fulcrum Therapeutics’ shares have rallied 31.4%.
Earnings of Fulcrum Therapeutics beat estimates in each of the last four quarters. Fulcrum delivered a four-quarter average earnings surprise of 393.18%.