SAN DIEGO - Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) today announced the discontinuation of luvadaxistat's development for schizophrenia-related cognitive impairment after the compound failed to meet the primary endpoint in the ERUDITE Phase 2 clinical study. The decision follows inconsistent results with the earlier INTERACT study, which had shown promise.
The ERUDITE trial's inability to replicate previous cognitive improvement findings was attributed to significant variability in cognitive measures and possible imbalances in baseline characteristics of the study participants. In contrast, the INTERACT study had demonstrated statistical significance in cognitive measures with a 50 mg dose of luvadaxistat.
Despite the setback with luvadaxistat, Neurocrine Biosciences is redirecting its focus towards advancing other candidates in its pipeline, specifically NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder, into Phase 3 clinical development.
Luvadaxistat, an investigational selective inhibitor targeting d-amino acid oxidase (DAAO), was being evaluated for its efficacy in treating cognitive impairments associated with schizophrenia (CIAS)—a condition affecting an estimated 80 percent of schizophrenia patients. Neurocrine had acquired the rights to luvadaxistat from Takeda Pharmaceutical Company (NYSE:TAK), Ltd.
Schizophrenia, affecting more than 20 million people globally, is known for its complex symptoms and significant economic impact, with annual costs in the U.S. exceeding $150 billion. The disorder's cognitive deficits are especially challenging to address with current treatments.
Neurocrine Biosciences, a neuroscience-focused biopharmaceutical company, has a history of developing treatments for neurological and psychiatric conditions with limited therapeutic options. Their portfolio includes FDA-approved treatments for various disorders and a robust pipeline of potential therapies.
This development marks a strategic pivot for the company as it continues to seek effective treatments for neuropsychiatric conditions. Information about the ERUDITE study can be found on ClinicalTrials.gov. The details in this article are based on a press release statement from Neurocrine Biosciences.
In other recent news, Neurocrine Biosciences has been the focus of several analyst firms following significant developments in its drug trials. The company's drug candidate, NBI-1117568, showed a statistically significant improvement in a dose-finding study, leading H.C. Wainwright to maintain its Buy rating for Neurocrine. Piper Sandler upgraded the company's stock from Neutral to Overweight, citing confidence in NBI-1117568, despite some concerns over recent clinical trial data. However, BMO Capital Markets reduced its price target due to uncertainties in trial results, yet maintained a Market Perform rating. TD Cowen also affirmed a Buy rating for the company, following promising results in clinical trials for the same drug.
Neurocrine Biosciences has reported over 30% year-over-year growth in sales of their drug, INGREZZA, leading to an increase in their sales guidance for the year to a range of $2.25 billion to $2.3 billion. The company is also awaiting FDA approval for Crinecerfont, a drug for congenital adrenal hyperplasia, which would further expand its product portfolio. These recent developments underscore Neurocrine's commitment to advancing its clinical pipeline and achieving sustained growth in the field of neuroscience.
InvestingPro Insights
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) is navigating through a challenging phase with the discontinuation of luvadaxistat for schizophrenia-related cognitive impairment. Despite this, the company's financial health and market performance provide a broader perspective on its potential resilience and future prospects.
According to InvestingPro data, Neurocrine Biosciences currently has a market capitalization of $12.24 billion, reflecting the company's substantial size in the biopharmaceutical industry. The company's P/E ratio stands at 35.66, indicating investor expectations of future earnings growth. Notably, the adjusted P/E ratio for the last twelve months as of Q2 2024 is 25.59, suggesting a more favorable valuation when considering near-term earnings growth.
With a reported revenue growth of 26.69% for the last twelve months as of Q2 2024, Neurocrine Biosciences demonstrates a strong ability to expand its financial base. This growth is further accentuated by a quarterly revenue increase of 30.37% in Q2 2024, showcasing the company's potential to maintain momentum in its operational performance.
InvestingPro Tips highlight that analysts are optimistic about the company's future, with 10 analysts having revised their earnings estimates upwards for the upcoming period. This consensus suggests confidence in the company's strategy and pipeline, despite the recent clinical trial outcomes. Additionally, Neurocrine Biosciences is expected to be profitable this year, with a history of profitability over the last twelve months. It is also worth noting that the company operates with a moderate level of debt, and its liquid assets exceed short-term obligations, providing financial stability.
For investors seeking more detailed analysis, additional InvestingPro Tips are available to provide a comprehensive understanding of Neurocrine Biosciences' financial health and market performance. There are a total of 12 InvestingPro Tips listed, which can be accessed for further insights on the company's outlook.
The company’s strategic focus on advancing other candidates in its pipeline could potentially offset the impact of luvadaxistat's discontinuation and offer long-term growth opportunities. As such, Neurocrine Biosciences remains a noteworthy entity in the biopharmaceutical sector for investors monitoring the development of treatments for neurological and psychiatric conditions.
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