Core Viewpoint - Nxera Pharma has entered an exclusive licensing agreement with Santhera Pharmaceuticals for the development, manufacturing, and commercialization of vamorolone for Duchenne Muscular Dystrophy (DMD) in Japan, South Korea, Australia, and New Zealand [1][5]. Group 1: Licensing Agreement Details - Nxera will be responsible for obtaining regulatory approval for vamorolone in the licensed territories, including conducting necessary clinical trials and leading commercialization and manufacturing activities [3]. - The agreement includes an upfront payment of USD 40 million to Santhera, consisting of USD 30 million in cash and USD 10 million as a strategic equity investment [6]. - Santhera is eligible for additional sales and regulatory milestone payments of up to USD 165 million, along with tiered royalties starting in the low teens on net sales of vamorolone in the licensed territories [6]. Group 2: Product and Market Potential - Vamorolone is positioned as a late-stage development candidate that addresses significant unmet needs for DMD patients in Japan and the Asia-Pacific region [2]. - The product is already approved and marketed as AGAMREE® in the US, EU, UK, and China, highlighting its established presence in the market [1][8]. - Vamorolone's differentiated safety and efficacy profile has the potential to change the standard of care for DMD by allowing early use, full dosing, and long-term treatment, addressing limitations of existing steroid therapies [4][8]. Group 3: Company Strategy and Vision - The transaction aligns with Nxera's mission to bring innovative medicines to patients in Japan and the APAC region, supporting its 2030 vision to build a high-growth, highly profitable biopharma company [5][8]. - Nxera's team has significant prior development and manufacturing experience with vamorolone, enhancing its capability to commercialize the product effectively in the targeted markets [3][5].

New analysis of a Phase 3 study of daridorexant shows that 50 mg improved both sleep and daytime functioning compared to placebo in women during menopausal transition ageBrigham and Women’s Hospital to study the effectiveness and safety of daridorexant for menopause-related insomnia symptoms Allschwil, Switzerland – January 5, 2026Idorsia Ltd (SIX: IDIA) announces the publication of “Efficacy and safety of daridorexant for the treatment of insomnia disorder in women during menopausal transition age: Insight ...

New analysis of a Phase 3 study of daridorexant shows that 50 mg improved both sleep and daytime functioning compared to placebo in women during menopausal transition ageBrigham and Women’s Hospital to study the effectiveness and safety of daridorexant for menopause-related insomnia symptoms Allschwil, Switzerland – January 5, 2026Idorsia Ltd (SIX: IDIA) announces the publication of “Efficacy and safety of daridorexant for the treatment of insomnia disorder in women during menopausal transition age: Insight ...

Core Insights - Idorsia Ltd presented new analyses of daridorexant for insomnia patients at World Sleep 2025, emphasizing its commitment to advancing sleep science [1][11] - The company highlighted the low abuse potential of daridorexant compared to other insomnia treatments, based on real-world data [3] - Daridorexant demonstrated efficacy in reducing wakefulness throughout the night, with significant improvements in sleep maintenance and daytime functioning [5][8] Efficacy and Safety of Daridorexant - A post-hoc analysis showed that daridorexant 50 mg effectively reduced wakefulness after sleep onset (WASO) in a dose-dependent manner, outperforming zolpidem in the second half of the night [5] - In women undergoing menopausal transition, daridorexant 50 mg improved sleep onset and maintenance without increasing next-morning sleepiness [6] - Patients with chronic insomnia and comorbid nocturia experienced improved sleep duration and reduced nocturia symptoms with daridorexant 50 mg, without adverse effects [8] Characterization of Insomnia Disorder - Analysis of over 5000 patients revealed that insomnia disorder negatively impacts both nighttime sleep and daytime functioning across various demographics [10] - The findings underscore the need for treatments that address the comprehensive burden of insomnia, improving both nocturnal and diurnal symptoms [10] Industry Context - World Sleep 2025 served as a platform for international collaboration among sleep professionals, focusing on advancements in sleep science and treatment [11] - Idorsia aims to challenge existing medical paradigms and develop transformative medicines, positioning itself as a leading biopharmaceutical company [12][13]