The company promises to advance a top investigational drug to late-stage testing, but investors might not think that's a fine idea. Neurocrine Biosciences (NBIX 3.77%) had some major news to report several days ago, but it was hardly beneficial to the company's stock. The latest information from the lab dampened enthusiasm for the company, sending its share price down by 16% week to date as of early Friday morning, according to data compiled by S&P Global Market Intelligence. One clear success out of four B ...

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 ...

Wednesday, Neurocrine Biosciences, Inc. NBIX topline data for its Phase 2 clinical study of NBI-1117568 (NBI-'568) in adults with schizophrenia. NBI-'568 is the first investigational, oral, muscarinic M4 selective agonist. 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. Also Read: Regulators Expected To Approve Innovative Schi ...

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 ...

Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a growth stock that can live up to its true potential can be a tough task. In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end. However, the task of finding cutting-edge growth stocks is made easy w ...

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 - Q2 2024 gross sales were $580 million, up 32% YoY from $440 million in Q2 2023 [6] - Full-year 2024 gross and net sales guidance raised to $2.25 billion - $2.3 billion, up from previous guidance of $2.1 billion - $2.2 billion [6] - INGREZZA sales grew over 30% YoY in Q2 2024, approaching $1.1 billion in the first half of 2024 [8] - Midpoint of 2024 sales guidance implies ~24% growth vs 2023 [9] Business Line Performance - INGREZZA continues strong growth momentum, with expanded sales force and new sprinkle formulation driving adoption [4][12] - Crinecerfont granted priority review by FDA, with PDUFA date set for late December 2024 [17][18] - NBI-845 AMPA modulator showed statistically significant reduction in MADRS scores in Phase 2 MDD study [16] - Two new Phase 1 molecules entered clinic: NBI-986 (M4 antagonist) and NBI-567 (M1 preferring agonist) [20] Market and Strategic Focus - Company sees significant growth opportunities in TD and HD chorea markets, with ~70-80% of patients still untreated [35][77] - Investing $125 million incremental in 2025 to support Crinecerfont launch and INGREZZA growth [7] - Focus on expanding commercial footprint and educating HCPs in psychiatry and long-term care segments [11][34] - Building rare endocrinology team for Crinecerfont launch, with average 20+ years biopharma experience [14] R&D Pipeline Progress - NBI-568 (M4 agonist) Phase 2 schizophrenia data expected in Q3 2024 [19] - Luvadaxistat Phase 2 cognitive impairment in schizophrenia data also expected in Q3 2024 [20] - Crinecerfont Phase 3 data published in NEJM, showing strong efficacy and tolerability [17] - Robust preclinical and clinical pipeline, with biologics expected to enter clinic next year [5] Management Commentary - Company believes it has the most robust neuroscience pipeline globally [5] - INGREZZA investments have consistently shown positive ROI through sales force expansions [4] - Crinecerfont expected to change treatment paradigm for CAH patients [5] - Focus on advancing high-value preclinical programs and investing behind positive proof-of-concept data [8] Q&A Session Highlights INGREZZA Growth and Market Opportunity - Sales force expansion justified by continued market growth and need to educate more HCPs [33] - All three business segments (psychiatry, neurology, LTC) showing strong growth [37] - ~70-80% of TD patients still untreated, indicating significant remaining opportunity [35][77] Pipeline Updates - NBI-568 adaptive trial design focuses on safety, with independent DMC guiding dose escalation [24][25] - Luvadaxistat cognitive benefits in schizophrenia represent significant unmet need if replicated [54][55] - NBI-845 focused on MDD initially, with potential to expand to other indications later [66] Crinecerfont Launch Preparation - Market education key focus, with "What the C@H?" initiative targeting endocrinologists and patients [73][74] - Centers of excellence important but majority of patients treated by community endocrinologists [73] - Strong Phase 3 data and >95% rollover rate into extension studies support favorable profile [61][62] Strategic Vision - Focus on organic growth and internal R&D transformation [47] - Moving from symptomatic to disease-modifying and curative therapies [47] - Strong financial position with $1.7 billion cash to support pipeline advancement [48]