Latest news with #RegeneronPharmaceuticalsInc
Yahoo
16-06-2025
- Business
- Yahoo
Regeneron, Sanofi Announce Positive Dupixent Results for Atopic Dermatitis
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) is one of the 11 most profitable NASDAQ stocks to buy now. On June 9, Regeneron Pharmaceuticals and Sanofi (NASDAQ:SNY) announced promising interim results from the open-label Phase 4 DISCOVER trial of Dupixent (dupilumab) in treating moderate-to-severe atopic dermatitis/AD in adolescents and adults with skin of color. These findings were presented at the 2025 Revolutionizing Atopic Dermatitis/RAD Conference on June 7. The DISCOVER trial enrolled 120 subjects with AD and Fitzpatrick skin types IV-VI (defined as light brown to black skin with high melanin content). Patients aged 12 years and older received Dupixent monotherapy every 2 weeks based on weight after a loading dose. At the 24-week mark, the study met its primary endpoint: 76% of participants achieved at least a 75% improvement in overall disease severity as measured by the Eczema Area and Severity Index (EASI-75). A pharmacist in a lab coat carefully analyzing a vial of medicine for its quality. Atopic dermatitis is a chronic skin condition driven by type 2 inflammation, often presenting with more pronounced symptoms and skin lesions in individuals with skin of color. Dupixent was invented using Regeneron's VelocImmune technology and developed in collaboration with Sanofi. It is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways without being an immunosuppressant. Over 1,000,000 patients are currently being treated with Dupixent globally. Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) discovers, invents, develops, manufactures, and commercializes medicines for treating various diseases worldwide. Sanofi (NASDAQ:SNY) is a healthcare company that researches, develops, manufactures, and markets therapeutic solutions. While we acknowledge the potential of REGN 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 . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error 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
Yahoo
02-06-2025
- Business
- Yahoo
Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron's Blockbuster Dupixent In Early Biomarker Response
Kymera Therapeutics, Inc. (NASDAQ:KYMR) on Monday revealed clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class, oral STAT6 degrader medicine. The findings significantly surpassed the company's expectations, demonstrating robust STAT6 degradation and a favorable safety profile, thereby derisking the program, the company said in a press release. Pharmacokinetics (PK): KT-621 demonstrated a favorable plasma PK profile after single and multiple doses. Rapid absorption was demonstrated with a median tmax of 2-4 hours and a mean half-life of 9-36 hours. There was a dose-proportional increase in exposure after multi-dosing, and a steady state was achieved by Day (PD): KT-621 demonstrated rapid, deep, and prolonged STAT6 degradation in blood after single doses of KT-621 and in blood and skin after multiple doses of KT-621. STAT6 levels in blood and skin were measured. Complete degradation within a cohort is defined as either a mean reduction of ≥95% or, when most subjects' STAT6 levels are reduced below the Lower Limit of Quantification (LLOQ), or both. In SAD, maximal degradation was achieved in blood as quickly as the first collected timepoint of 4 hours after a single dose, with mean STAT6 degradation reaching >90% across all SAD doses starting at 6.25 mg. All SAD cohorts at 75 mg or greater doses achieved >95% mean STAT6 degradation with STAT6 levels below LLOQ in multiple subjects. In MAD, STAT6 degradation was observed in blood at the first timepoint measured (8 hours) for doses above 1.5 mg. Steady-state, complete degradation, associated with STAT6 reductions below the LLOQ in the majority of subjects, was achieved at doses ≥50 mg, with recovery starting as early as 4 days after the last dose. In MAD, robust STAT6 degradation was observed in the skin at the first timepoint measured (Day 7) for doses above 1.5 mg. Steady-state, complete degradation, associated with ≥95% mean STAT6 degradation with STAT6 levels below LLOQ in multiple subjects, was achieved at doses ≥50 mg. Th2 Biomarkers: TARC reduction was observed for all KT-621 dose groups, with a median reduction of up to 37% at Day 14. The company says the results are comparable or superior to what was seen in the Sanofi SA (NASDAQ:SNY)/Regeneron Pharmaceuticals Inc's (NASDAQ:REGN) Dupixent (dupilumab) healthy volunteer study. The safety profile of KT-621 was undifferentiated from that of the placebo. The company's KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis patients is ongoing, with data expected to be reported in the fourth quarter of 2025. Two parallel Phase 2b trials in atopic dermatitis and asthma will start in 4Q25 and 1Q26, respectively. Price Action: KYMR stock was trading higher by 30.2% to $38.58 at last check Monday. Read Next:Photo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron's Blockbuster Dupixent In Early Biomarker Response originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Bloomberg
22-04-2025
- Business
- Bloomberg
Regeneron Inks $3 Billion Fujifilm Deal to Bolster US Drugmaking
Regeneron Pharmaceuticals Inc. agreed to pay Fujifilm Diosynth Biotechnologies more than $3 billion over the next decade to help manufacture its medicines in the US, as the threat of tariffs looms over the nation's drug supply. Fujifilm will produce drugs for Regeneron, maker of the $14 billion a year inflammation treatment Dupixent, at its facility in Holly Springs, North Carolina. The site is slated to begin operations later this year and future expansions are already being planned, Fujifilm said.
Globe and Mail
12-02-2025
- Business
- Globe and Mail
AMD Drugs Market to Hit USD 17.37 Billion by 2029 with 10.7% CAGR
"Regeneron Pharmaceuticals Inc. is a biotechnology company that focuses on the development, manufacturing, and distribution of therapeutic drugs such as Eylea and Eylea HD (high dose) in the US for the treatment of various retinal disorders including wet Age-Related Macular Degeneration (wAMD)." Key players in the Age-Related Macular Degeneration (AMD) drugs market include Regeneron Pharmaceuticals Inc. (US), Bayer AG (Germany), F. Hoffmann-La Roche Ltd (Switzerland), Novartis AG (Switzerland) The global Age-related Macular Degeneration drugs market is set to grow from USD 10.46 billion in 2024 to USD 17.37 billion by 2029, reflecting a robust CAGR of 10.7%. This growth is driven by rising AMD prevalence linked to lifestyle changes, increased R&D investment leading to more drug approvals, and improved reimbursement policies. The market is particularly expanding in developing countries and is witnessing a shift towards innovative therapies like gene therapy. However, challenges like high treatment costs and the off-label use of drugs such as Avastin hinder market potential. Notably, Eylea remains the leading product, while dry AMD therapies are expected to grow rapidly due to escalating cases among the aging population. North America is projected to be the fastest-growing region, with significant annual AMD case increases. Key players include Regeneron, Bayer, and Novartis, among others, with recent developments indicating a strong focus on new therapeutic solutions. Download PDF Brochure: Browse in-depth TOC on " Age-related Macular Degeneration (AMD) Drugs Market" 378 - Tables 54 - Figures 336 - Pages Based on molecules, the global Age-Related Macular Degeneration (AMD) drugs market has been segmented into Ranibizumab, Aflibercept, Faricimab, Pegcetacoplan, and other molecules including conbercept, brolucizumab, avacincaptad pegol, and bevacizumab-gamma among others. In 2023, aflibercept held the largest share of the Age-Related Macular Degeneration (AMD) drugs market by molecule. This large share of the molecule can be attributed to the high adoption of this molecule for the treatment of the wet or neovascular form of AMD. This adoption is due to the high affinity of the molecule for VEGF proteins preventing activation of native VEGF receptors and reducing angiogenesis and vascular permeability. Moreover, the efficacy of the molecule is supported by various research studies comparing the effectiveness of this molecule to other molecules used for AMD treatment. Additionally, the ongoing development of novel drug delivery methods and biosimilars for this molecule further supports the growth of the market of this molecule. Based on the type of AMD, the global Age-Related Macular Degeneration (AMD) drugs market has been segmented into wet AMD and dry AMD. In 2023, the wet AMD disease segment accounted for the largest share of the AMD market by type of AMD. The large share of wet AMD can be attributed to the rising prevalence of this disease affecting more than 20 million individuals globally. Reports from leading pharmaceutical companies highlight that more than 200,000 cases of wet AMD are reported in the US every year. This increase in wet AMD cases is attributed to the rising geriatric population with the World Health Organization (WHO) estimating a 2x increase in the number of individuals over 60 years of age by 2050. This market is also supported by new entrants targeting patients earlier in the disease cascade, with new drugs such as new entrants targeting patients earlier in the disease cascade with new drugs such as OPT-302 and KSI-301 being developed for the treatment of this disease. Based on end users, the global age-related macular degeneration (AMD) drugs market has been segmented into hospitals, specialty centers, and long-term care facilities. Hospitals accounted for the largest share of the AMD drugs market by end user in 2023. The large share of this segment is attributed to the rising prevalence of AMD cases and the ability of hospitals to provide advanced healthcare infrastructure and specialized treatment capabilities that aid in the treatment of patients with AMD. Furthermore, hospitals also support research that facilitates the development of better treatment for various diseases including AMD. Hospitals collaborate with pharmaceutical companies to ensure the optimal availability of AMD drugs for patients while providing comprehensive care, including diagnostics, treatment administration, and patient monitoring to enhance treatment outcome for the patients. The key regional markets for age-related macular degeneration (AMD) drugs market are North America, Europe, Asia Pacific, Latin America, Middle East and Africa. In 2023, North America accounted for the largest share of the market. This can be attributed to the increasing AMD cases in the region with reports from major pharmaceutical companies highlighting the occurrence of more than 200,000 new cases of AMD every year in the US. A rise in obesity, smoking, and poor diet in this region further contributes to the increase in the number of AMD cases. Additionally, an increase in the number of approvals for AMD drugs in the region further supports the market growth. Advanced healthcare infrastructure in these regions, including access to specialists and diagnostic tools, supports early detection and treatment. Request Sample Pages: The prominent players in the global Age-Related Macular Degeneration (AMD) market are Regeneron Pharmaceuticals Inc. (US), Bayer AG (Germany), F. Hoffmann-La Roche Ltd (Switzerland), Novartis AG (Switzerland), Apellis Pharmaceuticals (US), Coherus BioSciences (US), Astellas Pharma Inc. (Japan), Biogen (US), STADA Arzneimittel AG (Germany), Formycon AG (Germany), Biocon. (India), Outlook Therapeutics, Inc. (US), Intas Pharmaceuticals Ltd. (India), Teva Pharmaceutical Industries Ltd. (Israel), Chengdu Kanghong Biotech Company (China) and Sandoz Group AG (Switzerland). The market also includes players, such as Stealth BioTherapeutics Inc. (US), Ocular Therapeutix, Inc. (US), Opthea Limited (Australia), Kodiak Sciences Inc. (US), Innovent (China), Bio-Thera Solution (China), Alvotech (Iceland), Alteogen Inc. (South Korea), Shanghai Henlius Biotech, Inc. (China), Amgen Inc. (US), Ocumension Therapeutics. (China), and Adverum Biotechnologies, Inc. (US), that have drug candidates in phase 3 clinical trials. Regeneron Pharmaceuticals Inc. (US): Regeneron Pharmaceuticals Inc. is a biotechnology company that focuses on the development, manufacturing, and distribution of therapeutic drugs such as Eylea and Eylea HD (high dose) in the US for the treatment of various retinal disorders including wet Age-Related Macular Degeneration (wAMD). Eylea is one of the most adopted therapeutic drugs for the treatment of wet AMD across the globe. The company has partnered with major pharmaceutical companies such as Bayer AG to manufacture and distribute the drugs outside the US. Regeneron has operations in over 12 countries across the Asia Pacific, Europe, and North America, and conducts clinical trials in more than 60 countries. In 2023, the company allocated USD 96.2 million to improve Eylea HD, a higher hose of its already successful AMD drug Eylea. This drug allows patients to obtain similar therapeutic results with less number of injections reducing the treatment burden on the patients. The company has also developed innovative technologies like TRAPS and VelociSuite, which are used for the development of bispecific antibodies, essential for the development of next-generation ophthalmic drugs. F. Hoffmann-La Roche Ltd (Switzerland): Roche is a major pharmaceutical company that offers three FDA-approved drugs for the treatment of wet AMD among other retinal diseases: Lucentis, Vabysmo, and Susvimo, the company also provides Avastin (Bevacizumab) which is widely used as an off-label drug for the treatment of wet AMD owing to its affordability. In 2023, the company invested approximately 22% (USD 14.7 billion) of its annual revenue in R&D for the development of new drugs and exploring advanced research methods, including computational biology. The company has received marketing approvals for its AMD drugs in many countries, with recent expansions into markets like India. Roche's Genentech Ophthalmology Co-pay Program helps cover drug and administration costs making treatments more affordable. The company has operations in over 95 countries and offers a wide range of therapeutic products for a variety of diseases and disorders. Novartis AG (Switzerland): Novartis AG is a biotechnology company that focuses on the development and distribution of innovative medicines across key therapeutic areas, including cardiovascular, renal, metabolic, immunology, neuroscience, ophthalmology, and oncology. In 2023, Novartis became a pure-play innovative medicines company by spinning off its Sandoz generic and biosimilar business unit. The company strongly focuses on ophthalmology, and markets FDA-approved drugs like Lucentis and Beovu (brolucizumab) for treating wet Age-Related Macular Degeneration (AMD) across the globe. Novartis is also conducting phase 3 clinical trials for Beovu to expand its use for diabetic retinopathy, highlighting the company's focus on innovation and expanding treatment options. The company operates in over 130 countries and uses contract structures such as pay-over-time and outcome-based agreements to make its products more affordable and accessible to patients. For more information, Inquire Now!
Yahoo
05-02-2025
- Business
- Yahoo
Regeneron Pharmaceuticals Inc (REGN) Q4 2024 Earnings Call Highlights: Strong Revenue Growth ...
Revenue Growth: 10% year-over-year increase to $3.8 billion in Q4 2024. Net Income: $1.4 billion in Q4 2024, with diluted net income per share of $12.07. Full Year Revenue: $14.2 billion for 2024, excluding Ronapreve revenues. EYLEA and EYLEA HD Sales: Combined US net sales of $1.5 billion in Q4 2024. Libtayo Sales: Global net sales of $1.2 billion for 2024, with $367 million in Q4. Dupixent Sales: Worldwide net sales of $3.7 billion in Q4 2024, with US sales at $2.7 billion. Gross Margin: 86% on net product sales in Q4 2024. Free Cash Flow: Approximately $3.7 billion generated in 2024. Cash and Marketable Securities: $15.2 billion less debt at the end of 2024. Share Repurchase Authorization: Additional $3 billion, increasing capacity to $4.5 billion. Quarterly Dividend: Initiation with $0.88 per share, equivalent to $3.52 annually. 2025 R&D Spend Guidance: $5 billion to $5.2 billion. 2025 SG&A Guidance: $2.55 billion to $2.7 billion. 2025 Gross Margin Guidance: 87% to 88% on net product sales. 2025 Capital Expenditures Guidance: $850 million to $975 million. 2025 Effective Tax Rate Guidance: 11% to 13%. Warning! GuruFocus has detected 4 Warning Signs with REGN. Release Date: February 04, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Regeneron Pharmaceuticals Inc (NASDAQ:REGN) reported a strong fourth quarter with 10% revenue growth, driven by key franchises like Dupixent, Libtayo, and EYLEA. The company has a robust pipeline with approximately 40 product candidates across various therapeutic areas, showcasing significant future potential. Dupixent continues to be a transformative medicine with over 1 million patients worldwide and is well-positioned for future growth with new indications. Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced the initiation of a quarterly cash dividend program and an additional $3 billion share repurchase authorization, reflecting confidence in future cash flows. The company is advancing several promising R&D programs, including pivotal data expected for Linvoseltamab in multiple myeloma and odronextamab in follicular lymphoma. Regeneron Pharmaceuticals Inc (NASDAQ:REGN) faces ongoing competitive pressure in the anti-VEGF category, particularly affecting EYLEA sales. The company anticipates continued market dynamics that may put downward pressure on EYLEA business due to biosimilar competition. There are concerns about the safety profile of some pipeline products, such as the complement programs, which have shown class-specific adverse events. The company expects increased operating expenses in 2025, driven by costs to support the expanding late-stage pipeline and international expansion. Regeneron Pharmaceuticals Inc (NASDAQ:REGN) does not provide specific guidance on sales erosion expectations for the EYLEA franchise, leaving some uncertainty for investors. Q: Consensus numbers suggest expectations for annual sales erosion of about 7% annually over the next few years for the EYLEA franchise. Given the dynamics you described, do you think these expectations look reasonable? A: Marion McCourt, Executive Vice President - Commercial, stated that while they don't provide guidance, they believe EYLEA HD has a compelling profile with anticipated FDA approvals that could strengthen its position. However, they expect additional competitive pressure on EYLEA due to a biosimilar in the market. Q: Why did Regeneron decide to initiate a dividend now instead of waiting until the Sanofi development balance was paid off? A: Christopher Fenimore, CFO, explained that the decision was based on confidence in the repayment of the Sanofi development balance and a desire to diversify their capital allocation strategy. Initiating a dividend also opens up investment opportunities for funds with a dividend mandate. Q: How critical is it for Libtayo to hit overall survival in addition to DFS in the adjuvant CSCC indication? A: George Yancopoulos, Chief Scientific Officer, noted that while survival events are few due to the early stage of the disease, the FDA will ensure that data does not show unexpected trends. Marion McCourt added that the commercial opportunity in the US could benefit approximately 10,000 patients. Q: Could you speak to the magnitude of inventory impact on EYLEA HD last quarter and the dynamics with the biosimilar? A: Marion McCourt mentioned that there was an inventory build for EYLEA HD, impacting fourth-quarter sales. The combined net product sales impact was about $85 million, with higher inventory levels for EYLEA and lower for EYLEA HD. Leonard Schleifer noted recent legal victories that might limit biosimilar competition. Q: How are you thinking about balancing investments across the pipeline with numerous programs advancing to late-stage development? A: Leonard Schleifer emphasized that their primary capital allocation is towards R&D. They remain open to partnerships if beneficial but focus on making strategic decisions without fixed allocation quotas, given their extensive pipeline. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
