Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company") today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR (omalizum ...

Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) who were symptomatic despite H1 antihistamine treatment [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a confirmatory dose of 300 mg over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of the study results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted the milestone in expanding patient access to specialty medicines in key markets [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing to the European Medicines Agency (EMA) expected by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with a pipeline that includes nine disclosed biosimilar candidates targeting various therapeutic areas [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a robust infrastructure for R&D, clinical, manufacturing, and regulatory capabilities [16] - Advanz Pharma aims to improve patient lives through specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [14]

Core Insights - Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study for AVT23, a proposed biosimilar to Xolair® (omalizumab) [1][2][3] Study Details - The study was a randomized, double-blind, multicenter trial assessing the efficacy, safety, and immunogenicity of AVT23 in patients with Chronic Spontaneous Urticaria (CSU) [2] - The primary endpoint was met, demonstrating equivalence in therapeutic outcomes and comparable safety between AVT23 and Xolair® [2] - A total of 600 patients were enrolled, with efficacy and safety evaluated in 400 patients receiving a 300 mg dose over a 24-week period [2] Company Statements - Joseph McClellan, Chief Scientific Officer of Alvotech, emphasized the importance of these results for increasing global patient access to the biosimilar [3] - Dr. Sandeep Athalye, CEO of Kashiv, highlighted the advancement of their biosimilar pipeline and commitment to delivering cost-effective therapies [4] - Nick Warwick, Chief Medical Officer of Advanz Pharma, noted that the results mark a significant milestone in expanding access to specialty medicines [4] Regulatory Progress - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) for AVT23, with a filing expected with the European Medicines Agency (EMA) by year-end [5] Product Information - AVT23 is an investigational biosimilar to Xolair®, which is indicated for severe persistent allergic asthma and other conditions [6] - The biosimilarity of AVT23 has not yet been established by regulatory authorities [6] Company Backgrounds - Alvotech focuses on developing and manufacturing biosimilar medicines, with two biosimilars already approved and a pipeline of nine candidates targeting various diseases [9][10] - Kashiv BioSciences is a vertically integrated biopharmaceutical company with a strong focus on biosimilars and advanced clinical-stage assets [16] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a global presence in over 90 countries [14]

Core Viewpoint - HC Wainwright has initiated coverage on Septerna, Inc., highlighting its innovative drug design platform targeting previously undruggable G protein-coupled receptors (GPCRs) [1][3] Company Overview - Septerna is focused on GPCR drug discovery through its proprietary Native Complex Platform, aiming to maximize the potential of GPCR therapies [1] - The company has a deep pipeline of oral small molecule product candidates targeting endocrinology, immunology and inflammation, and metabolic diseases [2] Financial Insights - Analyst Raghuram Selvaraju noted that Septerna trades at a discount to its cash position and recent partnership cash, presenting a risk-mitigated investment opportunity with multiple catalysts expected in the next 6 to 12 months [3][7] - HC Wainwright has set a Buy rating for Septerna with a price target of $26 [3] Drug Development - The leading drug candidate, SEP-631, is a selective oral small molecule MRGPRX2 negative allosteric modulator for mast cell diseases, including chronic spontaneous urticaria (CSU) [4] - SEP-631 could provide a unique treatment option for CSU patients due to its selective mast cell inhibition and potential for combination therapy [4] Market Potential - If SEP-631 can match the efficacy of Novartis and Roche's Xolair, which generated nearly $3.9 billion in sales in 2023, it could achieve blockbuster status [5] - Septerna has entered an exclusive global collaboration with Novo Nordisk for the development of oral small-molecule medicines for obesity, type 2 diabetes, and other cardiometabolic diseases, starting with four development programs [6] Valuation Perspective - HC Wainwright emphasized that the financial implications of the partnership suggest Septerna's implied enterprise value may be negligible or negative, indicating the company is undervalued [7]

Core Insights - Dupixent (dupilumab) has demonstrated superiority over Xolair (omalizumab) in treating chronic rhinosinusitis with nasal polyps (CRSwNP) in patients with coexisting asthma, as evidenced by the EVEREST phase 4 study results presented at the EAACI Annual Congress [1][4][6] Study Overview - The EVEREST study involved 360 adults with severe, uncontrolled CRSwNP and coexisting asthma, randomized to receive either Dupixent 300 mg every two weeks or omalizumab based on weight and IgE levels [2][6] - Both treatments were administered alongside mometasone furoate nasal spray [2] Efficacy Results - Dupixent showed a 1.60-point superior reduction in nasal polyp size (p<0.00011) and an 8.0-point superior improvement in the ability to identify different smells (p<0.00011) compared to omalizumab [5] - Other significant improvements included a 0.58-point reduction in nasal congestion (p<0.00011), a 1.74-point reduction in symptom severity (p<0.00011), and a 12.7-point difference in health-related quality of life (p<0.00012) [5] - Asthma-related endpoints also favored Dupixent, with a 150 mL difference in lung function (pre-bronchodilator FEV1; p=0.0032) and a 0.48-point difference in asthma control (p<0.00012) [5] Safety Profile - The safety results were consistent with the known profiles of both medications, with adverse events reported in 64% of Dupixent patients and 67% of omalizumab patients [3][4] - Serious adverse events occurred in 2% of Dupixent patients and 4% of omalizumab patients, while discontinuation due to adverse events was reported in 3% and 1% respectively [3][4] Mechanism of Action - Dupixent targets interleukin-4 (IL-4) and interleukin-13 (IL-13), which are key drivers of type 2 inflammation, reinforcing its efficacy in treating both upper and lower respiratory diseases [4][8] Regulatory Status - Dupixent has received regulatory approvals in over 60 countries for various indications, including CRSwNP, asthma, and other allergic conditions, with more than one million patients currently treated globally [9][10]

RAPT Therapeutics (RAPT) FY 2025 Conference June 10, 2025 09:20 AM ET Speaker0 All right. Good morning, everyone. Thanks for joining us here at the Goldman Sachs Annual Healthcare Conference. Thrilled to be joined today by the team from RAP Therapeutics. Maybe I'll let you guys introduce yourself and then we can dive into the business. Speaker1 Great. So of all, thanks Corinne for the invitation. Really appreciate it. I'm excited to be here. My name is Brian Wong. I'm the CEO and President of Wrap Therapeut ...

Amneal Pharmaceuticals (AMRX) 2025 Conference June 05, 2025 09:20 AM ET Speaker0 To get an on time start. It's my pleasure. I am Jonas Schirleff from the Healthcare Investment Banking team here at Jefferies. Today we will be hearing from Chirag Entasos from the Amneal Pharmaceuticals team and I will hand it over to you. Thank you very much. Speaker1 Thank you. Thank you. Good morning everyone. Great to see you. Beautiful summer day and hopefully you guys get to go out and walk around and I think the Canadia ...

Financial Data and Key Metrics Changes - Alvotech raised its full-year revenue guidance for 2025 to $600 million to $700 million and adjusted EBITDA guidance to $200 million to $280 million [7][39] - The company achieved $110 million in product revenues during Q1 2025, an increase of $97 million or 784% compared to the same period in the prior year [30][31] - Adjusted EBITDA for Q1 2025 was $21 million, compared to negative adjusted EBITDA of $38 million for the same period in the prior year [39] Business Line Data and Key Metrics Changes - The Stellara biosimilar was launched in the U.S. market in late February 2025, following successful launches in Europe, Japan, and Canada [8][9] - Alvotech's biosimilar to Humira saw strong uptake in the U.S. market, with a penetration rate of at least 21% by year-end 2024 [20][21] - The company expects to move from two marketed biosimilars to six by early 2026, with three biosimilar filings under review in major markets [11][27] Market Data and Key Metrics Changes - In the U.S. market, Alvotech's Humira biosimilar represented about 12% of total demand for Humira and Humira biosimilars in 2024 [19][21] - The European Stellara market expanded by 9% year-over-year due to the entry of biosimilars, with Alvotech aiming for a double-digit market share by the end of 2025 [23] - Alvotech is the only developer to launch a Stellara biosimilar in Japan, indicating a strong competitive position in that market [24] Company Strategy and Development Direction - Alvotech plans to significantly increase the pace of development, moving four to six new biosimilar candidates into in-house process development each year [12] - The company is focused on a B2B model, which allows it to address a global patient population through 20 strategic commercial partnerships across 90 markets [12] - Alvotech aims to maintain a focus on quality and reliability rather than sacrificing value for market share in a competitive environment [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Stellara biosimilar in the U.S. market, especially after receiving the interchangeable designation [45] - The company anticipates that if tariffs on pharmaceuticals are applied, they will not disrupt operations or competitiveness in the U.S. market [13] - Management expects to be free cash flow positive in 2025, marking a significant milestone for the company [40] Other Important Information - Alvotech's net debt stood at $1.058 billion as of March 31, 2025, with expectations of mid-single-digit leverage by year-end [41] - The company closed the period with 301.9 million shares outstanding, including unvested earn-out shares [42] Q&A Session Summary Question: Can you clarify the interchangeable exclusivity and its implications? - Management confirmed the receipt of the interchangeable designation and noted that while some competitors may also obtain it, this designation is expected to drive faster uptake of their product [45][46] Question: What is the impact of stocking on the Stellara biosimilar sales? - Management clarified that the sales figures are driven by timing of orders rather than stocking, as they operate on a B2B model [50][51]

Alvotech (ALVO) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 and thank you for standing by. Welcome to the Alvotech Q1 twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Benedict Stephenson. Please go ahead. Speaker1 Thank you. Welcome to Ab ...

JYB1904目前处于中国II期临床试验，针对哮喘和慢性自发性荨麻疹。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，12月23日，RAPT Therapeutics（RAPT.US，下称RAPT）宣布获上海济煜医 药科技有限公司（下称"济煜医药"）授权引进长效IgE抗体JYB1904（RPT904）的大中华区外全球 权益，济煜医药将获得3500万美元预付款，最高6.725亿美元里程碑付款及一定比例的销售分成， 交易总额7.075亿美元。 治疗选择。奥马珠单抗以被获批用于治疗哮喘、CSU、慢性鼻窦炎伴有鼻息肉（CRSwNP）及食物 过敏等过敏性疾病。 RAPT总裁兼首席执行官Brian Wong表示，奥马珠单抗在今年初获批后市场占有率快速扩大证明了 这一治疗领域有巨大需求。而RPT904有望成为这一领域的同类最佳产品。RAPT计划于2025年下 半年启动RPT904 在食物过敏中的IIb期临床研究。 同时，RAPT Therapeutics还于23日披露了1.5亿美元的私募配售计划， 由The Column Group和 TCGX领投 ，新老投资者共同参与，包括 ...