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Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568
Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568

Business Upturn

time3 days ago

  • Business
  • Business Upturn

Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568

Tokyo, Japan and Cambridge, UK, 3 June 2025 – Nxera Pharma Co., Ltd. ('Nxera' or 'the Company'; TSE 4565) today announces that its partner, Neurocrine Biosciences ('Neurocrine') has dosed the first patient in its Phase 3 registrational program of NBI-1117568 (NBI-'568) as a potential treatment for schizophrenia, resulting in a payment of US$15 million to Nxera (Clinical Trial ID: NCT06963034). The US$15 million payment will be fully recognized as revenue in the second quarter of 2025. Nxera previously announced the initiation of the Phase 3 registrational program of NBI-'568 by Neurocrine in May 2025. The Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-'568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 280 patients. The primary endpoint of the study is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS). The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale. –END– About Nxera Pharma Nxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. We have built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high value, large and growing market and those in the broader APAC region. Behind that, and powered by our unique NxWave™ discovery platform, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline of potentially first- and best-in-class candidates is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology/neuropsychiatry, metabolic diseases and immunology and inflammation. Nxera employs approximately 400 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor RelationsShinya Tsuzuki, VP, Head of Investor RelationsShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager +81 (0)3 5962 5718 | +44 (0)1223 949390 |[email protected]

Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568
Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568

Yahoo

time3 days ago

  • Business
  • Yahoo

Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568

Tokyo, Japan and Cambridge, UK, 3 June 2025 – Nxera Pharma Co., Ltd. ('Nxera' or 'the Company'; TSE 4565) today announces that its partner, Neurocrine Biosciences ('Neurocrine') has dosed the first patient in its Phase 3 registrational program of NBI-1117568 (NBI-'568) as a potential treatment for schizophrenia, resulting in a payment of US$15 million to Nxera (Clinical Trial ID: NCT06963034). The US$15 million payment will be fully recognized as revenue in the second quarter of 2025. Nxera previously announced the initiation of the Phase 3 registrational program of NBI-'568 by Neurocrine in May 2025. The Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-'568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 280 patients. The primary endpoint of the study is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS). The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale. –END– About Nxera PharmaNxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. We have built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high value, large and growing market and those in the broader APAC region. Behind that, and powered by our unique NxWave™ discovery platform, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline of potentially first- and best-in-class candidates is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology/neuropsychiatry, metabolic diseases and immunology and inflammation. Nxera employs approximately 400 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor RelationsShinya Tsuzuki, VP, Head of Investor RelationsShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5962 5718 | +44 (0)1223 949390 |IR@ MEDiSTRAVA (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | Nxera@ Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group's actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise

Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568
Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568

Yahoo

time3 days ago

  • Business
  • Yahoo

Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568

Tokyo, Japan and Cambridge, UK, 3 June 2025 – Nxera Pharma Co., Ltd. ('Nxera' or 'the Company'; TSE 4565) today announces that its partner, Neurocrine Biosciences ('Neurocrine') has dosed the first patient in its Phase 3 registrational program of NBI-1117568 (NBI-'568) as a potential treatment for schizophrenia, resulting in a payment of US$15 million to Nxera (Clinical Trial ID: NCT06963034). The US$15 million payment will be fully recognized as revenue in the second quarter of 2025. Nxera previously announced the initiation of the Phase 3 registrational program of NBI-'568 by Neurocrine in May 2025. The Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-'568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 280 patients. The primary endpoint of the study is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS). The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale. –END– About Nxera PharmaNxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. We have built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high value, large and growing market and those in the broader APAC region. Behind that, and powered by our unique NxWave™ discovery platform, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline of potentially first- and best-in-class candidates is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology/neuropsychiatry, metabolic diseases and immunology and inflammation. Nxera employs approximately 400 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). For more information, please visit LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma Enquiries: Nxera – Media and Investor RelationsShinya Tsuzuki, VP, Head of Investor RelationsShinichiro Nishishita, VP Investor Relations, Head of Regulatory DisclosuresMaya Bennison, Communications Manager+81 (0)3 5962 5718 | +44 (0)1223 949390 |IR@ MEDiSTRAVA (for International Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44 (0)203 928 6900 | Nxera@ Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group's actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise

Bank of America Securities Sticks to Their Buy Rating for Neurocrine (NBIX)
Bank of America Securities Sticks to Their Buy Rating for Neurocrine (NBIX)

Business Insider

time15-05-2025

  • Business
  • Business Insider

Bank of America Securities Sticks to Their Buy Rating for Neurocrine (NBIX)

In a report released yesterday, Tazeen Ahmad from Bank of America Securities reiterated a Buy rating on Neurocrine (NBIX – Research Report), with a price target of $183.00. The company's shares closed yesterday at $118.78. Confident Investing Starts Here: Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter According to TipRanks, Ahmad is an analyst with an average return of -5.3% and a 43.00% success rate. Ahmad covers the Healthcare sector, focusing on stocks such as Sarepta Therapeutics, PTC Therapeutics, and Alnylam Pharma. In addition to Bank of America Securities, Neurocrine also received a Buy from J.P. Morgan's Anupam Rama in a report issued on May 8. However, on May 5, BMO Capital maintained a Hold rating on Neurocrine (NASDAQ: NBIX). Based on Neurocrine's latest earnings release for the quarter ending March 31, the company reported a quarterly revenue of $572.6 million and a net profit of $7.9 million. In comparison, last year the company earned a revenue of $515.3 million and had a net profit of $43.4 million

Neurocrine Biosciences (NasdaqGS:NBIX) Begins Phase 1 Study Of New VMAT2 Inhibitor For Neurological Conditions
Neurocrine Biosciences (NasdaqGS:NBIX) Begins Phase 1 Study Of New VMAT2 Inhibitor For Neurological Conditions

Yahoo

time06-03-2025

  • Business
  • Yahoo

Neurocrine Biosciences (NasdaqGS:NBIX) Begins Phase 1 Study Of New VMAT2 Inhibitor For Neurological Conditions

Neurocrine Biosciences announced the initiation of a Phase 1 clinical study for the compound NBI-1140675, a new VMAT2 inhibitor. This development could influence investor sentiment, though the company's stock experienced a 3% decline over the last week. This price movement may be linked to broader market concerns, such as the 2% drop in the tech-heavy Nasdaq Composite, driven by tariff uncertainties and volatile trading in tech stocks. While Neurocrine's broader portfolio and recent clinical advancements hold potential, overall market pressures, including the U.S. tariff situation and the resulting economic uncertainties, could be affecting investor behavior. Contributing factors also include a general 2% market decline due to investor concerns over tariffs and expected tightening of economic conditions. Despite this period's challenges, Neurocrine continues to strengthen its pipeline and expand applications for existing treatments like valbenazine, demonstrating ongoing commitment to advancing neurological and psychiatric therapies. See the full analysis report here for a deeper understanding of Neurocrine Biosciences. Neurocrine Biosciences has achieved a total return of 32.54% over the past five years, despite underperforming the broader market this past year. Several factors could have contributed to this longer-term performance. Throughout the years, Neurocrine has initiated several critical studies, such as launching a Phase 1 clinical trial for NBI-1140675 and a Phase 3 study for osavampator targeting major depressive disorder. Simultaneously, the company has expanded its product lineup, exemplified by the commercial launch of CRENESSITY, FDA-approved for CAH. These developments have likely bolstered investor confidence in the company's potential. Financially, Neurocrine reported a revenue increase in Q4 2024 to US$627.7 million, although net income saw a decline. Additionally, a significant share repurchase program highlighted commitment to shareholder value, with US$500 million allocated for stock buybacks. Leadership transitions, including a new CEO, indicate strategic shifts as the company continues to focus on growth and expansion in the biopharmaceutical domain. Unlock the insights behind Neurocrine Biosciences' valuation and discover its true investment potential Assess the potential risks impacting Neurocrine Biosciences' growth trajectory—explore our risk evaluation report. Invested in Neurocrine Biosciences? Simplify your portfolio management with Simply Wall St and stay ahead with our alerts for any critical updates on your stocks. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:NBIX. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio

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