Latest news with #autoimmunediseases
Globe and Mail
a day ago
- Business
- Globe and Mail
GRI Bio Participates in the Virtual Investor 'What's Your Story' Summer Spotlight On-Demand Conference
– Video webcast now available on-demand LA JOLLA, CA, July 22, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) ('GRI Bio' or the 'Company'), a biotechnology company advancing an innovative pipeline of Natural Killer T ('NKT') cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced Marc Hertz, PhD, President, Chief Executive Officer and Director of GRI BIO, participated in the Virtual Investor 'What's Your Story' Summer Spotlight On-Demand Conference. As part of the event, Dr. Hertz dove deeper into his dedication to the Company, how he got to where he is today and provided insight into why he is so passionate about the Company's programs in development. The on-demand video webcast is now available on as well as the Events page under the Investors section of the Company's website ( About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio's therapies are designed to target the activity of Natural Killer T ('NKT') cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT ('iNKT') cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio's lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 diverse NKT ('dNKT') agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.
Yahoo
16-07-2025
- Business
- Yahoo
Goldman Sachs Resumes Coverage of Immunovant (IMVT) with a Hold Rating
Immunovant, Inc. (NASDAQ:IMVT) is one of the best oversold NASDAQ stocks to buy now. On July 10, Goldman Sachs analyst Corinne Johnson resumed coverage of Immunovant, Inc. (NASDAQ:IMVT) with a Hold rating and set a price target of $18.00. A closeup of a scientist working with a microscope in a biotech laboratory. The analyst supported the Neutral rating by stating that it sees limited downside to Immunovant, Inc. (NASDAQ:IMVT), and that a challenging regulatory backdrop also exists for the company, necessitating a cautious outlook. Immunovant, Inc. (NASDAQ:IMVT) has approximately $714 million in cash and cash equivalents as of March 31, which management declared provides runway for announced indications through GD readout anticipated in 2027. Immunovant, Inc. (NASDAQ:IMVT) develops treatments for autoimmune diseases. Its product pipeline includes batoclimab and IMVT-1402. Both are novel antibodies targeting the neonatal fragment crystallizable receptor (FcRn). While we acknowledge the potential of IMVT as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
30-06-2025
- Business
- Yahoo
argenx Advances Clinical Development of ARGX-119 in Congenital Myasthenic Syndromes
Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP), argenx's collaborative discovery model June 30, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its plan to advance the clinical development of ARGX-119, a first-in-class agonist antibody to muscle-specific kinase (MuSK), to a registrational study in patients with congenital myasthenic syndromes (CMS) following the analysis of topline data from the Phase 1b study. Detailed results will be presented at a future medical meeting. 'The results of our Phase 1b ARGX-119 study in congenital myasthenic syndromes, an ultra-rare disorder that affects patients from birth, builds on our experience and understanding of myasthenic disorders and aligns with our aspiration to serve even more patients living with these debilitating diseases,' said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. 'ARGX-119 is the sixth molecule developed through our Immunology Innovation Program to show proof-of-concept, reflecting the strength of our innovation model where our deep knowledge of the biology and expertise in antibody engineering come together to push the boundaries of what's possible. argenx remains focused on uncovering new biological insights into misunderstood diseases to meaningfully change the lives of patients who have long-been underserved,' said Peter Ulrichts, Ph.D., Chief Scientific Officer of argenx. The decision to advance the development of ARGX-119 in CMS is supported by the results of the Phase 1b study. ARGX-119 demonstrated a favorable safety and tolerability profile, which was the primary endpoint. Efficacy was evaluated across multiple secondary and exploratory endpoints, including Six-Minute Walk Test (6MWT), Quantitative Myasthenia Gravis (QMG) score and Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Consistent improvements were observed in treated DOK7-CMS patients through the 12-week study across multiple efficacy scores. Phase 1b CMS Study Design The Phase 1b, multicenter, randomized, double-blinded, placebo-controlled clinical trial assessed safety, tolerability, PK, immunogenicity, and preliminary efficacy of ARGX-119 in participants with DOK7-CMS. The study was also designed to demonstrate proof-of-biology through preliminary efficacy assessments, including muscle weakness, fatigability, daily activities and patient-reported global health outcomes. The clinical trial spanned approximately 11 months across a screening period (up to 28 days), a 12-week treatment period and a follow-up period of nearly seven months. At baseline, eligible participants were randomized 4:1 to receive intravenous ARGX-119 or placebo. The primary objective was to evaluate safety and tolerability; secondary objectives included PK, immunogenicity and preliminary efficacy of ARGX-119 in participants with DOK7-CMS. All but one of the patients enrolled in the Phase 1b study also participated in an observational natural history study initiated by argenx in 2024 to better understand the CMS patient journey and disease burden, helping to inform future development plans. About Congenital Myasthenic Syndromes Congenital Myasthenic Syndromes (CMS) are an ultra-rare and heterogenous group of congenital neuromuscular disorders caused by genetic defects that are essential for the integrity of the neuromuscular junction. Early age of onset and fatigable muscle weakness are considered clinical hallmarks of CMS. Muscle weakness can be debilitating and life-threatening causing difficulties in speaking or swallowing, impaired or absent mobility, proximal arm and leg weakness, and respiratory insufficiency. DOK7 variations are one of the more frequent and severe causes of CMS, accounting for approximately 24% of CMS cases. There are no approved treatments. The prevalence of CMS is estimated to be 5 per 1M (DOK7-CMS estimated to be 1.2 per 1M). About ARGX-119 ARGX-119 is a first-in-class humanized agonist monoclonal antibody (mAb) that specifically targets and activates muscle-specific tyrosine kinase (MuSK) to promote maturation and stabilization of the neuromuscular junction (NMJ). It is a mAb derived from llamas and discovered using the argenx SIMPLE Antibody™ platform technology. ARGX-119 is being developed for patients with neuromuscular disease, including congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA). ARGX-119 was developed through argenx's IIP program in collaboration with the world's leading key opinion leaders on MuSK and the NMJ, Professor Steven J. Burden from MGH, Professor Shohei Koide from NYU and Professor Jan Verschuuren and Associate Professor Maartje Huijbers from LUMC. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Instagram, Facebook, and YouTube. Media: Colin McBeancmcbean@ Investors: Alexandra Roy aroy@ Forward Looking Statements The contents of this announcement include statements that are, or may be deemed to be, 'forward looking statements.' These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'aims,' 'committed,' or 'plan' and include statements argenx makes concerning its commitment to improving the lives of people suffering from severe autoimmune diseases; its plan to advance the clinical development of ARGX-119 to a registrational study in CMS patients; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by 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
National Post
29-06-2025
- Business
- National Post
Aurinia Pharmaceuticals to Host Conference Call to Discuss AUR200 Phase 1 Study Results on June 30, 2025
Article content ROCKVILLE, Md. & EDMONTON, Alberta — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that it will host a webcast and conference call on June 30, 2025, at 8:30 a.m. ET to discuss AUR200 Phase 1 study results. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. A replay of the webcast will be available on Aurinia's website. Article content About Aurinia Article content Article content Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing AUR200, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Article content Article content Article content Article content Article content Article content
Yahoo
24-06-2025
- Business
- Yahoo
Market Accelerates Amid Rising Disease Prevalence, Kinase Innovation, and Demand for Safer Treatments
The global kinase inhibitors in autoimmune diseases market is experiencing significant growth, driven by rising autoimmune disease prevalence and advancements in biotechnology, specifically in targeted therapies like JAK inhibitors. These innovations provide a precise approach to treatment, addressing the root causes of immune dysfunction and benefiting from expedited regulatory approvals. While challenges such as high costs and competition persist, heavy investments in research and clinical trials suggest sustained market growth. North America is set to lead, backed by robust healthcare infrastructure and regulatory benefits. Major players like Pfizer and Sun Pharmaceuticals are enhancing product offerings, underscoring the competitive landscape. Dublin, June 24, 2025 (GLOBE NEWSWIRE) -- The "Kinase Inhibitors in Autoimmune Diseases Market - A Global and Regional Analysis: Focus on Regional and Country Analysis - Analysis and Forecast, 2025-2035" report has been added to offering. The global kinase inhibitors in autoimmune diseases market is currently in the growth stage of its lifecycle. With the increasing prevalence of autoimmune diseases and advancements in biotechnology, the demand for targeted therapies such as JAK inhibitors has been rising. Increasing demand for kinase inhibitors in autoimmune diseases therapies is anticipated to support the growth of the global kinase inhibitors in autoimmune diseases market during the forecast period 2025-2035. The global kinase inhibitors in autoimmune diseases market is expected to grow at a significant rate due to advancements in diagnostic technologies, the development of innovative therapies, and increasing awareness among patients and healthcare providers. These therapies offer a more specific approach to treatment, addressing the underlying causes of immune system dysfunction, which is a key driver for market expansion. The market is also benefitting from regulatory support and faster drug approvals, allowing new treatments to reach the market more quickly. However, challenges like high treatment costs, side effects, and competition from established therapies still are investing heavily in research and clinical trials to expand their drug pipelines and enhance treatment options, signaling continued market growth. As the market matures, it is expected to face increasing competition and pricing pressures, but the demand for more targeted and personalized treatments is likely to sustain its upward trajectory. North America is expected to dominate the global kinase inhibitors in autoimmune diseases market during the forecast period due to its advanced healthcare infrastructure, high prevalence, and increased awareness of the disease. The region also benefits from regulatory advantages and a strong pharmaceutical presence, which accelerates the availability of effective treatments and drives the growth of the global kinase inhibitors in autoimmune diseases market. How Can This Report Add Value to an Organization?Product/Innovation Strategy: Product launches and innovations in the global kinase inhibitors in autoimmune diseases market are focused on advancing treatment options to improve patient care. These innovations aim to enhance the efficacy of therapies and streamline the detection and management of the disease. Key players in the market, such as Pfizer, and Sun Pharmaceuticals, have been involved in the development of therapies for kinase inhibitors in autoimmune Strategy: Enterprises led by market leaders in the global kinase inhibitors in autoimmune diseases market are continuously working on updating their product portfolios with innovative treatments to maintain competitiveness. A detailed competitive benchmarking of the key players has been conducted, providing insights into how these companies compare in terms of product offerings, market share, and innovation. This benchmarking provides readers with a clear understanding of the market landscape and the positions of the leading players. Additionally, comprehensive competitive strategies, such as partnerships, agreements, and collaborations, will help readers identify untapped revenue opportunities in the Developments Launches: In March 2025, Pfizer Korea launched Litfulo (ritlecitinib tosylate), a new Janus kinase (JAK) inhibitor, for the treatment of severe alopecia areata in adolescents and adults, thereby expanding treatment options for patients aged 12 and older in Korea. Regulatory Activities: In July 2024, The U.S. FDA approved Sun Pharmaceutical Industries Ltd.'s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor, for the treatment of adults with severe alopecia areata, a chronic autoimmune disease. Demand - Drivers and Limitations The following are the drivers for the global kinase inhibitors in autoimmune diseases market: Rising Prevalence of Autoimmune Diseases Advancements in Kinase Inhibition Technology Growing Demand for Non-Immunosuppressive Therapies The global kinase inhibitors in autoimmune diseases market is expected to face some limitations, too, due to the following challenges: High Treatment Costs Limited Indication Scope Key Market Players and Competition Synopsis Pfizer Eli Lilly and Company Reistone Biopharma Incyte Corporation Bristol Myers Squibb Galapagos NV Aclaris Therapeutics Kadmon Pharmaceuticals Sanofi Ono Pharmaceutical Co. Ltd Key Topics Covered: Executive Summary1. Global Kinase Inhibitors in Autoimmune Diseases Market: Industry Outlook1.1 Market Overview and Ecosystem1.2 Market Trends1.3 Epidemiological Analysis of Autoimmune Diseases1.3.1 By Region1.4 Clinical Trials1.4.1 By Phase1.4.2 By Sponsor Type1.5 Regulatory Landscape / Compliance1.5.1 Legal Requirement and Framework in the U.S.1.5.2 Legal Requirement and Framework in the E.U.1.5.3 Legal Requirement and Framework in Asia-Pacific1.6 Market Dynamics1.6.1 Market Drivers1.6.2 Market Restraints1.6.3 Market Opportunities2. Global Kinase Inhibitors in Autoimmune Diseases Market, By Region, $Million, 2023-20352.1 North America2.1.1 Market Dynamics2.1.2 Market Sizing and Forecast2.1.2.1 North America Kinase Inhibitors in Autoimmune Diseases Market (by Country)2.1.2.1.1 U.S.2.1.2.1.2 Canada2.2 Europe2.2.1 Market Dynamics2.2.2 Market Sizing and Forecast2.2.2.1 Europe Kinase Inhibitors in Autoimmune Diseases Market (by Country)2.2.2.1.1 U.K.2.2.2.1.2 Germany2.2.2.1.3 France2.2.2.1.4 Italy2.2.2.1.5 Spain2.2.2.1.6 Rest-of-Europe2.3 Asia-Pacific2.3.1 Market Dynamics2.3.2 Market Sizing and Forecast2.3.2.1 Asia-Pacific Kinase Inhibitors in Autoimmune Diseases Market (by Country)2.3.2.1.1 Japan2.3.2.1.2 China2.3.2.1.3 India2.3.2.1.4 Rest-of-Asia-Pacific2.4 Rest-of-the-World2.4.1 Market Dynamics2.4.2 Market Size and Forecast3. Global Kinase Inhibitors in Autoimmune Diseases Market - Competitive Benchmarking and Company Profiles3.1 Competitive Landscape3.1.1 Key Strategies and Developments by Company3.1.1.1 Funding Activities3.1.1.2 Mergers and Acquisitions3.1.1.3 Regulatory Approvals3.1.1.4 Partnerships, Collaborations and Business Expansions3.1.2 Key Developments Analysis3.2 Company Profiles3.2.1 Company Overview3.2.2 Product Portfolio3.2.3 Target Customers/End Users3.2.4 Analyst View4. Research Methodology For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error 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
