Latest news with #PANSS
Business Upturn
3 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]
Yahoo
3 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
Yahoo
3 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
Yahoo
29-05-2025
- Business
- Yahoo
Neurocrine Biosciences, Inc. (NBIX)'s M4 Agonist Shows Promise in Schizophrenia Phase 2 Trial, Phase 3 Launched
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) has announced promising results from its Phase 2 trial of NBI-1117568, a first-in-class investigational oral muscarinic M4 selective agonist for schizophrenia. Presented at the American Society of Clinical Psychopharmacology 2025 Annual Meeting, the study showed that a 20 mg once-daily dose significantly improved schizophrenia symptoms, achieving a 7.5-point greater reduction on the Positive and Negative Syndrome Scale (PANSS) than placebo at six weeks. Improvements were also seen on the Clinical Global Impression of Severity (CGI-S) scale as early as Week 2, with continued benefit through Week 6. A scientist studying the effects of neurotrophic factors on neuronal survival. NBI-1117568 was generally safe and well tolerated, with somnolence and dizziness as the most common side effects and no significant weight gain or clinically meaningful cardiovascular events. Discontinuation rates due to adverse events were similar to placebo. Higher doses showed greater mean improvements but did not reach statistical significance. These results have prompted Neurocrine Biosciences, Inc. (NASDAQ:NBIX) to launch a global Phase 3 trial to further evaluate the drug's efficacy and safety in adults with acute schizophrenia symptoms. NBI-1117568's novel mechanism offers hope for a more targeted and tolerable treatment option for patients. While we acknowledge the potential of NBIX to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than NBIX and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
