Wednesday, Neurocrine Biosciences, Inc. (NASDAQ: NBIX) topline data for its Phase 2 clinical study of NBI1117568 (NBI-'568) in adults with schizophrenia. The new data showed that the once-daily 20 mg dose of NBI-'568 induced an average 18.2-point reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) after six weeks, compared to 10.8 points in the placebo group. That 7.5-point difference reached statistical significance with a p-value of p=0.011. The company noted that none of the other ...

Shares of Neurocrine Biosciences (NBIX) 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 Negat ...

Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York 2024 Wells Fargo Healthcare Conference on September 5 in Boston SAN DIEGO, Aug. 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at two upcoming investor conferences in September. Chief Executive Officer Kevin Gorman, Chief Business Development and Strategy Officer Kyle Gano, and Chief Financial Officer Matt Abernethy will present at the Morgan Stanley 22nd Annual Global Healthcare Conference ...

The Once-Daily 20 mg Dose Met the Primary Endpoint, Demonstrating a Statistically Significant 7.5-Point Improvement (p=0.011, 0.61 Effect Size) in the PANSS Total Score Compared to Placebo at Week 6 with an 18.2-Point PANSS Total Score Improvement from Baseline The Once-Daily 20 mg Dose Met Additional Endpoints, Demonstrating Statistically Significant Improvements in Clinical Global Impression of Severity Scale and Marder Factor Score Positive Symptom Change and Negative Symptom Change NBI-'568 Was Generall ...

SAN DIEGO, Aug. 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the Canaccord Genuity 44th Annual Growth Conference in Boston at 3:30 p.m. Eastern Time on Wednesday, August 14, 2024. Kyle Gano, Chief Business Development and Strategy Officer, and Todd Tushla, Vice President of Investor Relations, will present at the conference. The live presentation will be webcast and may be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of th ...

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koto_feja The arrow is pointing up these days for Neurocrine Biosciences (NASDAQ:NBIX) as this neuro- and neuropsych-focused biotech continues to report healthy sales of its core commercial product Ingrezza, while also delivering clinical wins and a deepening pipeline of high-potential drugs. Neurocrine shares are up about 15% since my last update, which is a little better than the overall biotech sector over that time period. With healthy sales growth from Ingrezza, a likely launch of crinecerfont in 2025, ...

Financial Data and Key Metrics Changes - Q2 2024 gross sales reached $580 million, a 32% increase from $440 million in the prior year [6][4] - The company raised its 2024 gross and net sales guidance to a range of $2.25 billion to $2.3 billion, up from the previous range of $2.1 billion to $2.2 billion [6][7] - GAAP SG&A expense guidance was updated by approximately $35 million, with $20 million allocated for the growth of ININGREZZA and $15 million for a non-GAAP impairment charge [6][7] Business Line Data and Key Metrics Changes - ININGREZZA experienced over 30% year-over-year growth, with sales approaching $1.1 billion in the first half of 2024 [8][9] - The company is expanding its sales force to enhance the reach and education of healthcare providers regarding ININGREZZA [10][11] - A new sprinkle formulation of ININGREZZA was launched to cater to patients with swallowing difficulties [12][13] Market Data and Key Metrics Changes - The TD market has grown significantly, with more healthcare providers diagnosing and treating tardive dyskinesia (TD) [10][11] - The company plans to increase its psychiatry and long-term care sales teams to better serve the growing number of TD treaters [11][34] - The CAH market is expected to see significant changes with the potential approval of Crinecerfont, which has been granted priority review by the FDA [18][19] Company Strategy and Development Direction - The company aims to maintain its leadership in neuroscience by investing in its R&D pipeline and expanding its commercial footprint [6][8] - Neurocrine is focused on organic growth, moving towards internally discovered programs and exploring gene therapy [47][48] - The strategic plan includes launching Crinecerfont and advancing the clinical programs for NBI-'845 and NBI-'568 [46][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of ININGREZZA and the upcoming launch of Crinecerfont, highlighting the significant unmet needs in the CAH community [18][19] - The company is well-positioned financially, with $1.7 billion in cash, allowing for continued investment in R&D and potential new therapies [48] - Management emphasized the importance of evolving their approach to meet the needs of healthcare providers and patients [10][34] Other Important Information - The company has a robust clinical pipeline, with multiple new compounds entering the clinic and significant progress in ongoing studies [21][22] - The FDA has granted breakthrough therapy designation and orphan drug designation to Crinecerfont, enhancing its potential market position [18][19] Q&A Session Summary Question: Insights on NBI-'568 data and Phase I study - Management confirmed that data from the Phase I proof-of-concept study will be delivered soon, emphasizing confidence in the safety and tolerability of the doses chosen for the study [22][23] Question: Sales force expansion rationale - The company is expanding its sales force to meet the growing needs of the psychiatry segment and long-term care, expecting positive ROI from this investment [34][35] Question: Growth drivers for ININGREZZA - All three business segments (psychiatry, neurology, long-term care) are experiencing growth, with continued efforts to raise awareness and educate healthcare providers [37][38] Question: Future opportunities for M4 beyond schizophrenia - Management indicated that while there are many potential opportunities, the focus remains on the data from the Phase II study before considering expansions into other indications [71]

For the quarter ended June 2024, Neurocrine Biosciences (NBIX) reported revenue of $590.2 million, up 30.4% over the same period last year. EPS came in at $0.63, compared to $0.95 in the year-ago quarter. The reported revenue represents a surprise of +7.56% over the Zacks Consensus Estimate of $548.7 million. With the consensus EPS estimate being $1.15, the EPS surprise was -45.22%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to d ...

Neurocrine Biosciences (NBIX) came out with quarterly earnings of $0.63 per share, missing the Zacks Consensus Estimate of $1.15 per share. This compares to earnings of $0.95 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -45.22%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.04 per share when it actually produced earnings of $0.42, delivering a surprise of -59.62%. Over the las ...