FORT MYERS, Fla.--(BUSINESS WIRE)--NeoGenomics will present research at ISLB 2025 showing high concordance between its RaDaR ST and RaDaR 1.0 MRD assays, plus four additional posters. ...

Metsera has become the obesity drug market's hottest ticket. ...

Core Insights - Argenx and Insmed reported strong third-quarter earnings, exceeding analyst expectations, which positively impacted their stock prices [1][2][3]. Company Performance - Argenx reported an adjusted profit of $5.18 per share on sales of $1.13 billion, significantly surpassing analyst projections of $4.49 per share and $1.07 billion in sales. Year-over-year, earnings increased by 273% and sales rose by 97% [2]. - Insmed reported a loss of $1.75 per share on sales of $142.3 million, which was worse than the expected loss of $1.28 per share and sales of $115.4 million. In the same period last year, Insmed lost $1.27 per share with sales of $93.4 million [3]. Sales Guidance - Insmed raised its guidance for Arikayce sales to a range of $420 million to $430 million, up from the previous estimate of $405 million to $425 million. Analysts had predicted $423.5 million in sales for Arikayce this year [4]. Stock Market Reaction - In premarket trading, Argenx shares rose by 1.5% to $834.23, while Insmed shares surged by 11.1% to $185.50. Argenx ranks No. 49 on the IBD 50 list of elite growth stocks with a strong IBD Digital Composite Rating of 98 [5]. - Insmed's stock has more than doubled this year, driven by enthusiasm for its experimental drug, treprostinil palmitil inhalation powder (TPIP), which has the potential to compete with existing treatments for high blood pressure in the lungs [6].

Hemostemix's Boots on the Ground in Florida October UpdateOctober 30, 2025 11:29 AM EDT | Source: Hemostemix Inc.Calgary, Alberta--(Newsfile Corp. - October 30, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option individuals suffering from pain related to angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiom ...

NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against MoonLake Immunotherapeutics (“Moonlake” or the “Company”) (NASDAQ: MLTX). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. The class action concerns whether Moonlake and certa ...

Summary of Invivyd Revolution Pivotal Program Conference Call Company Overview - **Company**: Invivyd - **Product**: VYD2311, an antibody developed as an alternative to COVID vaccination and for other potential uses Key Industry Insights - **COVID Landscape**: The current and future endemic COVID situation is still evolving, with significant systemic medical implications beyond respiratory symptoms, including cardiovascular and organ damage [9][10] - **Vaccine Efficacy**: Initial COVID vaccines showed short-term efficacy, but long-term protection has been questioned due to the evolving nature of the virus and the limitations of the human immune response [10][12] Core Points and Arguments - **Antibody Technology**: Invivyd focuses on developing antibodies that enhance human immune responses, aiming for a best-in-class safety and efficacy profile [6][7] - **Expansion Beyond COVID**: The company is exploring treatments for acute COVID, long COVID, and other viral pathogens like RSV and measles [7] - **Clinical Trials**: The Revolution Program includes a Phase 1/2 study and a Phase 3 randomized placebo-controlled study (Declaration) to assess VYD2311's efficacy in preventing symptomatic COVID-19 [29][34] - **Efficacy Expectations**: The Declaration study aims for a 70% to 90% reduction in symptomatic COVID-19 compared to placebo over a 90-day period [36][64] Important Data and Projections - **Commercial Opportunity**: U.S. COVID vaccine sales totaled $3.8 billion last year, with lower uptake compared to influenza vaccines, indicating a significant market opportunity for VYD2311 [46][74] - **Safety Profile**: VYD2311 has shown a favorable safety profile even at suprapharmacologic doses, with no significant adverse findings in preclinical testing [31][33] Additional Considerations - **Public Perception**: There is a notable fear and mistrust regarding COVID vaccination among the public, which presents an opportunity for Invivyd to restore trust through its antibody solutions [13][14] - **Regulatory Coordination**: The Liberty study will assess the safety and tolerability of mRNA vaccines versus VYD2311, which may inform future labeling and guidance for healthcare providers [42][43] - **Manufacturing and Delivery**: Invivyd is confident in its manufacturing capabilities to meet potential demand for VYD2311, which is designed for easy administration [90] Conclusion - Invivyd is positioned to offer a novel solution in the COVID landscape with VYD2311, focusing on safety, efficacy, and addressing public concerns about vaccination. The company is actively preparing for clinical trials and commercial opportunities while navigating regulatory landscapes.

Alnylam Pharmaceuticals (NasdaqGS:ALNY) Q3 2025 Earnings Call October 30, 2025 08:30 AM ET Speaker2Good morning ladies and gentlemen and welcome to the Alnylam Pharmaceuticals 3Q 2025 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session, and if at any time during this call you require immediate assistance, please press star zero for the operator. Also note that this call is being recorded on Thursday, October 30, ...

Financial Data and Key Metrics Changes - The company reported a 3% revenue growth in Q3 2025 compared to Q3 2024, driven by strong commercial execution [47] - Launch products generated $257 million in revenue, representing a 67% year-over-year growth [47] - Non-GAAP diluted EPS grew by 18% for the quarter [50] Business Line Data and Key Metrics Changes - The MS business showed resilient performance, positively impacted by gross-to-net adjustments and strong demand for VUMERITY, despite generic erosion of TECFIDERA in Europe [48][52] - LEKEMBY achieved global revenues growing 82% compared to Q3 2024, with a prescriber base growth of 14% quarter-over-quarter [38] - Skyclaris saw a 30% year-over-year revenue growth, now available in 34 countries [42] - ZERZUVEY experienced a 19% revenue growth compared to the previous quarter, with 80% of prescriptions written as first-line therapy [45] Market Data and Key Metrics Changes - The anti-amyloid market grew approximately 15% this quarter, indicating a positive trend in the market dynamics [41] - Blood-based biomarker testing is expected to reach up to 350,000 tests this year, a 75% increase compared to the previous year [41] Company Strategy and Development Direction - The company is focused on expanding its early-stage pipeline while maintaining a robust late-stage pipeline with 10 Phase III or Phase III-ready programs [18][28] - Strategic acquisitions, such as Alcion Therapeutics, are aimed at enhancing the company's capabilities in treating various diseases [15] - The company aims to deliver $1 billion in gross savings and $800 million in net savings under the Fit for Growth initiative by 2025 [62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong business trends observed in Q3, leading to an improved revenue outlook [50] - The company anticipates increased competitive pressures on the ex-U.S. MS business, particularly for TECFIDERA in Europe [61] - Management remains optimistic about the potential of LEKEMBY in the presymptomatic Alzheimer's disease population [35] Other Important Information - The company generated approximately $1.2 billion of free cash flow in the quarter, exiting with $4 billion in cash and marketable securities [58] - The company is actively working on securing reimbursement in European markets for Skyclaris and expanding its geographic reach [55] Q&A Session Summary Question: Impact of EVOQUE trial on Lykkembe franchise - Management indicated that the results of the EVOQUE trial will determine the impact on the Lykkembe franchise and the need for a broader portfolio [66][68] Question: Growth potential in immunology - Management highlighted the company's historical presence in immunology and the potential for growth in rare immunology and overlapping areas with existing experience [72][74] Question: Confidence in late-stage pipeline - Management expressed confidence in the late-stage pipeline, citing compelling Phase II data and a thoughtful progression in derisking the pipeline [79][81] Question: Early experience with LAKEMBY subcutaneous maintenance - Management reported positive feedback from payers and healthcare providers regarding the subcutaneous maintenance option, anticipating gradual uptake [88][90] Question: Commercial implications of prevention studies - Management acknowledged the potential commercial implications of positive trial results but emphasized the need for improved capacity and referral quality in the healthcare system [96][98]

Apellis Pharmaceuticals (NasdaqGS:APLS) Q3 2025 Earnings Call October 30, 2025 08:30 AM ET Speaker3Good morning ladies and gentlemen. Thank you for standing by and welcome to the Apellis Pharmaceuticals third quarter 2025 earnings conference call. Please be advised that today's conference is being recorded. I would now like to turn the call over to Eva Stranoski, Head of Investor Relations. Please go ahead. Good morning and thank you for joining us to discuss Apellis' third quarter 2025 financial results. W ...

ATLANTA, GA / ACCESS Newswire / October 30, 2025 / Dogwood Therapeutics, Inc. (Nasdaq:DWTX) (the "Company"), a developmentstage biotechnology company developing new medicines to treat pain and neuropathy, announced today that it will report third quarter 2025 financial results on Thursday, November 6, 2025, before the open of the financial markets. About Dogwood Therapeutics Dogwood Therapeutics (Nasdaq:DWTX) is a development-stage biopharmaceutical company focused on developing new medicines to treat pain ...