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Neurocrine Biosciences posted disappointing Phase II data for its schizophrenia drug NBI-1117568, driving a steep fall in the share price. NBI-568 came up short in terms of PANSS reduction, with a 7.5pt placebo-adjusted reduction missing the double-digit target the Street wanted to see. Management remains optimistic about '568, planning Phase III trials, but it seems optimistic to think that Phase III results are likely to be good enough to make '568 truly competitive.
Tokyo, Japan and Cambridge, UK, 28 August 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – notes the announcement by its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX) that NBI-1117568 (NBI-‘568) has delivered positive topline results from its Phase 2 clinical study in adults with schizophrenia. NBI-'568 is the first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia.
Neurocrine Biosciences said on Wednesday its experimental drug to treat adults with schizophrenia met the main goal in a mid-stage study.
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 Generally Safe and Well Tolerated at All Doses Studied The Once-Daily 20 mg Dose Efficacy, Safety and Tolerability Phase 2 Results Support Advancement to Phase 3 in Schizophrenia in Early 2025 Company to Host Conference Call with Management at 8 a.m. EDT SAN DIEGO , Aug. 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive top-line data for its Phase 2 clinical study of NBI-1117568 (NBI-'568) in adults with schizophrenia.
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.
Neurocrine (NBIX) is well positioned to outperform the market, as it exhibits above-average growth in financials.
Ingrezza sales are on the rise, with a 32% increase in sales in Q2'24, and there is still an attractive runway of growth ahead for the drug. The Phase II results of '845 in major depressive disorder exceeded expectations, potentially adding over $1B to the revenue pool and positioning it as a potential future rival to Spravato. The upcoming Phase II readout for '568 (an M4 agonist) in schizophrenia is a potentially significant value-creation opportunity, but it will likely require a double-digit improvement in PANSS.
While the top- and bottom-line numbers for Neurocrine (NBIX) give a sense of how the business performed in the quarter ended June 2024, it could be worth looking at how some of its key metrics compare to Wall Street estimates and year-ago values.
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.
INGREZZA® (valbenazine) Second Quarter Net Product Sales of $580 Million Representing 32% Year-Over-Year Growth INGREZZA ® (valbenazine) 2024 Net Product Sales Guidance Raised to $2.25 - $2.3 Billion Top-Line Phase 2 Data Readouts for NBI-'568 and Luvadaxistat Remain On Track in Q3 SAN DIEGO , Aug. 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter ended June 30, 2024 and provided an update on its 2024 financial guidance. "At Neurocrine, we are energized by the tremendous opportunity we see to help many more patients, and we are encouraged by our recent progress, including INGREZZA's continued success in treating tardive dyskinesia and Huntington's disease chorea and the FDA's decision to grant Priority Review for crinecerfont to treat congenital adrenal hyperplasia," said Kevin Gorman, Ph.D.