Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) announced updated data on its investigational gene therapy DB-OTO from the CHORD study, which targets profound genetic hearing loss due to variants of the otoferlin (OTOF) gene [1][9] Group 1: DB-OTO Gene Therapy - DB-OTO is a cell-selective, dual adeno-associated virus (AAV) vector gene therapy designed to provide durable hearing to individuals with profound, congenital hearing loss caused by OTOF gene variants [2] - The CHORD study is a registrational phase I/II multicenter, open-label study evaluating the safety, tolerability, and efficacy of DB-OTO in infants, children, and adolescents with OTOF-related hearing loss, currently enrolling participants under 18 years across the U.S., U.K., Spain, and Germany [3] - The study consists of two parts: Part A involves a single intracochlear infusion of DB-OTO in one ear, while Part B involves administering DB-OTO in both ears at the selected dose from Part A [4] Group 2: Study Results - Out of 12 participants aged 10 months to 16 years, 11 experienced clinically meaningful hearing improvements, with three achieving normal hearing levels; eight participants with longer follow-up showed stability or continued improvement in hearing [5][7] - Among three participants who completed speech assessments, all showed substantial improvement, with one able to identify one- and two-syllable words without visual cues [6] - The trial met its primary endpoint, with nine participants showing hearing improvements at a threshold of ≤70 decibel hearing level (dBHL) at week 24 [6] Group 3: Regulatory and Market Context - DB-OTO has received Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy designations from the FDA, with the European Medicines Agency also granting Orphan Drug Designation [7] - REGN plans to submit regulatory filings for DB-OTO in the U.S. later this year, pending discussions with the FDA [8] Group 4: Portfolio Diversification - REGN is diversifying its portfolio as its lead drug Eylea faces competition from Roche's Vabysmo, which has seen significant uptake [10] - Eylea HD sales surged 29% in the second quarter due to increased demand, helping to counter the decline in Eylea sales [13] - The company's oncology franchise has been bolstered by recent FDA approvals for Libtayo and linvoseltamab-gcpt, as well as Ordspono for treating certain types of lymphoma [15][16][17]

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the top stocks to buy in Michael Burry’s stock portfolio. On October 6, the company announced it is poised to incur an $83 million in-process research and development (IPR&D) charge. Regeneron Pharmaceuticals, Inc. (REGN) Prepares for $83M Charge Copyright: nexusplexus / 123RF Stock Photo The charge is related to an $80 million up-front payment made to Hansoh Pharmaceuticals Group Company Limited as part of a 2025 license agreement. In addition to ...

Core Insights - Regeneron Pharmaceuticals announced significant progress in their investigational gene therapy DB-OTO for profound genetic hearing loss, with 11 out of 12 participants in the CHORD trial experiencing clinically meaningful hearing improvements, including three achieving normal hearing levels [1][2][3] Group 1: Clinical Trial Results - The CHORD trial involved pediatric participants with profound hearing loss due to variants of the OTOF gene, with 12 participants aged 10 months to 16 years receiving DB-OTO via intracochlear infusion [2][9] - The primary endpoint was met, with 9 participants showing hearing improvements at a threshold of ≤70 decibels (dBHL) at week 24, indicating a level that typically does not require cochlear implantation [3][11] - Among participants with longer follow-up, eight showed stability or continued improvement in hearing, and all three who completed speech assessments demonstrated significant improvements in speech recognition [4][5] Group 2: Safety and Regulatory Status - The surgical procedure and DB-OTO were well tolerated, with no adverse findings related to DB-OTO reported; however, two serious adverse events were noted, unrelated to the therapy [5][6] - A U.S. regulatory submission for DB-OTO is planned for later this year, pending discussions with the FDA, which has granted multiple designations to the therapy, including Orphan Drug and Fast Track [6][7] Group 3: Background on Hearing Loss - OTOF-related hearing loss is a rare condition affecting approximately 20-50 newborns per year in the U.S., caused by variants in the OTOF gene, leading to a lack of functional otoferlin protein critical for auditory nerve communication [8][13] - The CHORD trial is a Phase 1/2 multicenter, open-label study evaluating the safety and efficacy of DB-OTO in children with OTOF-related hearing loss, currently enrolling participants across multiple countries [9][10]

Company Overview - Regeneron Pharmaceuticals develops and provides innovative medicines for various conditions, including eye diseases, atopic dermatitis, asthma, and rheumatoid arthritis [2] Valuation and Performance - Regeneron stock is currently trading approximately 44% lower than its 1-year peak and has a price-to-sales (PS) multiple below its 3-year average, indicating potential value [1] - The company has demonstrated sound revenue growth of 5.4% over the last twelve months (LTM) and an average of 0.3% over the past three years [5] - Regeneron maintains a free cash flow margin of nearly 25.0% and an operating margin of 27.0% LTM, showcasing strong cash generation capabilities [5] - The stock is trading at a moderate price-to-earnings (PE) ratio of 13.4, despite its favorable fundamentals [5] - Compared to the S&P 500, Regeneron offers lower valuation, greater LTM revenue growth, and superior margins [5] Future Outlook - The average forward returns for Regeneron are projected at 12.7% over 6 months and 25.8% over 12 months, with a win rate exceeding 70% for both time frames [6] - The Trefis High Quality Portfolio, which includes Regeneron, has consistently outperformed its benchmarks, including the S&P 500, indicating a robust investment strategy [9]

Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) has received FDA approval for the label expansion of its PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][9] Group 1: Approval and Efficacy - Libtayo is now approved for high-risk CSCC patients, marking it as the only immunotherapy to show efficacy in this setting [5][9] - The FDA's approval was based on the late-stage C-POST study, which demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo [4][9] - An additional regulatory application for Libtayo is under review in the European Union, with a decision expected by the first half of 2026 [3] Group 2: Financial Performance - Libtayo's sales reached $661.6 million in the first half of 2025, reflecting an 18% year-over-year increase [5] - REGN's stock has declined by 20.5% year to date, contrasting with the industry's growth of 10.5% [2] Group 3: Portfolio Diversification - REGN is actively working to diversify its portfolio, especially as its lead drug Eylea faces competition from Roche's Vabysmo [12] - Eylea sales in the U.S. increased by 29% in the second quarter due to higher demand for a higher dose version [13] - The oncology franchise has been bolstered by the recent FDA approvals of linvoseltamab-gcpt for relapsed or refractory multiple myeloma and Ordspono for follicular lymphoma, despite setbacks with odronextamab [10][11]

The U.S. Food and Drug Administration on Wednesday cleared Regeneron Pharmaceuticals' immunotherapy, Libtayo, as an add-on treatment for skin cancer patients at high risk of their disease returning after surgery and radiation, the drugmaker said. ...

Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial Libtayo is the current standard of care in advanced CSCC; approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today ...

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The news team covers key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2][3] Group 2 - The team delivers news and insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4][5] - All content published by Proactive is edited and authored by humans, ensuring adherence to best practices in content production and search engine optimization [5]

Looking into the current session, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) shares are trading at $603.61, after a 0.60% increase. Moreover, over the past month, the stock increased by 5.27%, but in the past year, fell by 39.40%. Shareholders might be interested in knowing whether the stock is undervalued, even if the company is performing up to par in the current session. Regeneron Pharmaceuticals P/E Ratio Analysis in Relation to Industry PeersThe P/E ratio is used by long-term shareholders to assess t ...

Group 1 - Regeneron Pharmaceuticals, Inc. is considered a promising biotech stock, with Generate Investment Management Ltd acquiring 12,000 shares valued at approximately $6,300,000 in the second quarter [1] - The company recently reported a Phase 2 COURAGE study where garetosmab showed exceptional efficacy in treating fibrodysplasia ossificans progressiva [2] - Regeneron maintains a strong presence in the U.S. with a new manufacturing facility in Rensselaer and a deal with Fujifilm, supported by strong growth in Dupixent and a healthy balance sheet [3] Group 2 - Regeneron Pharmaceuticals, Inc. specializes in medicines for various diseases, including EYLEA and Dupixent, and was incorporated in 1988 [4]