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SAN DIEGO - Neurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) today announced that its Phase 2 clinical trial of NBI-1117568, a novel treatment for schizophrenia, met its primary endpoint. The trial demonstrated a significant reduction in the severity of symptoms compared to placebo at week six of the study.
The investigational drug, also known as NBI-'568, is an oral, muscarinic M4 selective agonist and represents a new approach in the treatment of schizophrenia. The Phase 2 study findings showed an average 7.5-point improvement in the Positive and Negative Syndrome Scale (PANSS) total score for patients taking a once-daily 20 mg dose, with a 0.61 effect size and a p-value of 0.011. Additionally, the 20 mg dose led to an 18.2-point improvement from baseline in PANSS total scores.
Secondary endpoints, including the Clinical Global Impression of Severity (CGI-S) scale and Marder Factor Scores for positive and negative symptom changes, also showed statistically significant improvements.
Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences, highlighted the compelling benefit-risk profile of the dosing regimen and the company's anticipation for advancing NBI-'568 into Phase 3 development early next year.
According to Dr. Maurizio Fava of Massachusetts General Hospital, the drug was well tolerated, with minimal gastrointestinal effects and no significant weight gain, a common side effect of current antipsychotics.
The safety profile of NBI-'568 was favorable, with treatment discontinuation rates due to adverse events comparable to placebo. The most common adverse events were somnolence, dizziness, and headache, while gastrointestinal and cardiovascular-related events were low in frequency and not clinically relevant.
The data supports the progression of NBI-'568 into the next phase of clinical development, with Phase 3 trials expected to commence in early 2025.
Neurocrine Biosciences also has other muscarinic receptor-targeting compounds in its pipeline, including NBI-1117567, NBI-1117569, and NBI-1117570, which are in early-stage clinical development for various neurological and psychiatric disorders.
The press release states that more than 20 million people worldwide are affected by schizophrenia, with the associated costs in the United States exceeding $150 billion annually. Current treatments often lead to significant health impacts, underlining the need for new therapeutic options.
This article is based on a press release statement from Neurocrine Biosciences.
In other recent news, Neurocrine Biosciences has made significant strides in their developments. The company reported a robust second quarter with 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. Furthermore, Jefferies has raised its price target for Neurocrine Biosciences shares to $189.00, maintaining a Buy rating. This adjustment comes in anticipation of promising data from the company's Phase 2 study of NBI-568, a potential treatment for Schizophrenia.
The firm's financial forecast includes a $1.8 billion risk-adjusted peak sales estimation in the Schizophrenia market for NBI-568. This projection is based on the drug's potential to match or exceed the efficacy and safety profile of existing treatments. Neurocrine Biosciences is also awaiting FDA approval for Crinecerfont, a drug for congenital adrenal hyperplasia, expected by the end of the year.
In addition, the company is investing in its sales force expansion and making advancements in its clinical pipeline in neuroscience. These recent developments underline Neurocrine Biosciences' focus on sustained growth in the field of neuroscience.
InvestingPro Insights
Following the positive results from its Phase 2 clinical trial for NBI-1117568, Neurocrine Biosciences (NASDAQ:NBIX) is garnering attention not only for its potential impact on schizophrenia treatment but also for its financial health and stock performance. With a market capitalization of $15.4 billion and a recent Price to Earnings (P/E) ratio of 44.19, the company is trading at a premium, reflecting high expectations from the market. However, closer analysis using adjusted metrics from the last twelve months as of Q2 2024 reveals a more favorable P/E ratio of 32.19, suggesting better value relative to near-term earnings growth.
A key InvestingPro Tip to consider is that analysts have revised their earnings expectations upwards for the upcoming period, indicating confidence in the company's financial prospects. Additionally, Neurocrine Biosciences is noted for trading with low price volatility, which may appeal to investors looking for stability in their biotech investments.
From a financial standpoint, the company's revenue growth is notable, with a 26.69% increase over the last twelve months as of Q2 2024. This is complemented by a robust gross profit margin of 68.55%, which speaks to the efficiency of the company's operations. Furthermore, Neurocrine Biosciences' operating income margin stands at 25.7%, underscoring its profitability even as it invests in the development of new treatments.
For investors interested in additional insights, there are 14 more InvestingPro Tips available, offering a comprehensive analysis of Neurocrine Biosciences' financial health and stock performance. These can be accessed through the company's InvestingPro profile at https://www.investing.com/pro/NBIX. With these insights, investors can make more informed decisions as they watch the company's progress in Phase 3 development and beyond.
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