Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab) for treating chronic spontaneous urticaria (CSU) in children aged two to 11 years who have not responded adequately to standard antihistamine treatment [1][2]. Group 1: Approval and Clinical Studies - The positive CHMP opinion is based on data from the LIBERTY-CUPID clinical study program, which includes two phase 3 studies and a single-arm phase 3 study involving children aged two to 11 years with CSU [2]. - Dupixent is already approved for CSU in certain adults and adolescents in multiple jurisdictions, including the US, EU, and Japan [2]. Group 2: Regulatory Developments - In the US, a supplemental biologics license application for Dupixent in children aged two to 11 years with CSU has been accepted for review, with a decision from the FDA expected by April 2026 [3]. Group 3: Disease Background - Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease characterized by debilitating hives and recurring itch, often inadequately controlled by standard antihistamine treatments [5]. - Many patients with CSU experience significant impacts on their quality of life due to uncontrolled symptoms [5]. Group 4: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 (IL4) and interleukin-13 (IL13) signaling pathways, which are key drivers of type 2 inflammation [6]. - The Dupixent development program has demonstrated significant clinical benefits and a reduction in type 2 inflammation in phase 3 studies [6]. Group 5: Market Presence - Dupixent has received regulatory approvals in over 60 countries for various indications, including atopic dermatitis, asthma, and CSU, with more than 1.4 million patients currently treated globally [7][8].

2月27日，赛诺菲宣布度普利尤单抗注射液（商品名：达必妥）获国家药品监督管理局（NMPA）正式批准两项新适应症：用于治疗大疱性类天疱疮 (bullous pemphigoid, BP)成人患者，以及用于6岁及以上儿童哮喘患者的维持治疗。此次双适应症获批标志着达必妥成为中国首个且目前唯一获批用于治疗 大疱性类天疱疮的靶向生物制剂，以及中国首个且目前唯一覆盖6岁及以上儿童哮喘患者的抗IL-4Ra单抗，为这两类患者带来突破性的创新治疗选择。 度普利尤单抗是一种全人源单克隆抗体，可抑制白细胞介素-4(IL-4)和白细胞介素-13(1L-13)通路的信号转导，而不是免疫抑制剂。在度普利尤单抗开发计 划的多项III期临床试验中，该药表现出显著的临床获益，可抑制2型炎症，并证实IL-4和IL-13是2型炎症的关键核心驱动因素，在多种相关的常见并发疾 病中发挥重要作用。 在中国，目前度普利尤单抗已获批用于治疗外用药控制不佳或不建议使用外用药的成人、青少年、儿童、6个月及以上婴幼儿全年龄段中重度特应性皮 炎，适合系统治疗的中度至重度成人结节性痒疹，成人大疱性类天疱疮，6岁及以上儿童和成人哮喘患者以及慢性阻塞性肺疾病成人患者的维 ...

Syndax Pharmaceuticals (NasdaqGS:SNDX) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Speaker10Good day, everyone. Welcome to the Syndax fourth quarter 2025 earnings conference call. Today's call is being recorded. If you would like to ask a question following the company's prepared remarks, please press star five during the call. At this time, I would like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals.Speaker13Thank you, operator. Welcome, and thank you a ...

In this article, we will look at the 11 Best Strong Buy Healthcare Stocks to Invest In.On February 23, Steven Wieting, CIO Group chief investment strategist, appeared on CNBC’s ‘The Exchange’ to talk about the stock market and the recent price action in stocks. CNBC reported that staples, healthcare, and utilities are all leading, outperforming since January 1 and showing that this is not a one-day trend but has rather been going on since the turn of the calendar. Wieting stated that a lot is going on in th ...

Ligand Pharmaceuticals (NasdaqGM:LGND) Q4 2025 Earnings call February 26, 2026 08:30 AM ET Speaker7Thank you for standing by, and welcome to Ligand's fourth quarter 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by 1 on your telephone keypad. If you would like to withdraw your question, please press star one again. ...

Transitioned from a vertically integrated COVID-19 vaccine manufacturer to a lean, R&D-focused licensing organization centered on the Matrix-M adjuvant technology. Secured over $800 million in non-dilutive capital over 18 months through strategic milestones and upfront payments from Sanofi and Pfizer. Leveraged the Pfizer agreement to validate Matrix-M's utility across diverse disease areas, with potential for billions in long-term revenue through milestones and royalties. Optimized the operational ...

Skip to main content Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv Novavax raises 2026 adjusted revenue outlook on strength in vaccine deals Earlier this month, the U.S. Food and Drug Administration initially refused to review rival Moderna's (MRNA.O), opens new tab mRNA-based flu vaccine, then reversed course a week later after the company amended its application. The biotech now expects 2026 adjusted revenue of $230 million to $270 million, up from its prio ...

Robust financial performance driven by full year 2025 royalty revenue growth of 48% Reiterating 2026 financial guidance of $245-$285 million in revenues and adjusted earnings per diluted share1 of $8.00-$9.00 Conference call and webcast at 8:30 a.m. Eastern time today JUPITER, Fla., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today reported financial results for the three and twelve months ended December 31, 2025, and provided an operating forecast and business updat ...

Snowflake (NYSE:SNOW) Q4 2026 Earnings call February 25, 2026 05:00 PM ET Speaker10Good day, ladies and gentlemen. Thank you for joining today's Snowflake Q4 FY 2026 earnings call. My name is Tia. I will be your moderator for today's call. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. If you would like to ask a question, please press star 1 on your telephone keypad. I would now like to pass the call over to your host, Katherine ...

Adagene FY Conference Summary Company Overview - **Company**: Adagene (NasdaqGM:ADAG) - **Focus**: Development of immuno-oncology drugs, specifically targeting microsatellite stable colorectal cancer (MSS-CRC) with low response rates to current therapies [2][3] Key Points and Arguments Drug Development and Efficacy - **Lead Compound**: ADG126, a masked anti-CTLA-4 antibody, is being developed in combination with KEYTRUDA (pembrolizumab) for late-line MSS-CRC without liver metastases [3][4] - **Response Rates**: ADG126 has shown a response rate between 15% and 30% depending on dosage, with a median overall survival of 20 months in the lowest dose cohort [3][5] - **Safety Profile**: The discontinuation rate is less than 10%, with no grade 4 or 5 adverse events reported, indicating a favorable safety margin [5][15] Market Opportunity - **Target Population**: Approximately 10,000 patients in the U.S. represent the MSS-CRC without liver metastases, a challenging tumor type for immuno-oncology agents [12] - **Historical Context**: Current standard of care has a median overall survival of 10-14 months, highlighting the need for more effective treatments [2][11] Collaboration and Funding - **Sanofi Investment**: Sanofi committed to an equity investment of up to $25 million, with the first tranche of $17 million received at $2 per share. This funding supports the ongoing phase 2 trial of ADG126 [6][7] - **Trial Collaboration**: Sanofi will evaluate ADG126 in combination with their bispecific PD-1 IL-15 in over 100 patients with solid tumors [6][7] Competitive Landscape - **CTLA-4 Mechanism**: CTLA-4 therapies like Yervoy (ipilimumab) and Imjudo (tremelimumab) generate close to $4 billion in revenues, indicating a robust market for effective CTLA-4 inhibitors [8][9] - **Differentiation**: ADG126 is positioned as a safer alternative with a better safety margin compared to existing CTLA-4 therapies, which have shown high toxicity [10][76] Future Developments - **Upcoming Data**: Updates on ADG126's efficacy and safety are expected in the coming months, including data from triplet combinations and a phase 2 trial in neoadjuvant colorectal cancer patients [20][23] - **Regulatory Pathway**: Plans for a randomized phase 3 trial focusing on overall survival as the primary endpoint are in discussion with the FDA [62][73] Additional Important Insights - **Combination Potential**: ADG126 is seen as a versatile partner for various combinations beyond PD-1, including potential combinations with VEGF and TGF inhibitors [36][38] - **Strategic Partnerships**: The company aims to pursue more licensing deals and trial collaborations to expand its market reach and evaluate novel regimens [23][24] This summary encapsulates the critical insights from the Adagene FY Conference, highlighting the company's strategic direction, drug development progress, and market potential in the oncology space.