Core Viewpoint - Regeneron and Johnson & Johnson face challenges in the early intervention field for smoldering multiple myeloma (SMM), despite promising new data. The adoption of Regeneron's Lynozyfic and Johnson's Darzalex may be slow due to the need for physicians to balance the risks of overtreatment with the difficulty in identifying high-risk patients who may benefit [3][4]. Group 1: Regeneron's Lynozyfic - Lynozyfic shows a total response rate (ORR) of 100% and a complete response rate (CR) of 36.8% for high-risk SMM, but these rates may not be as significant for active myeloma. The key measure of success is whether the drug can delay disease progression and improve survival [4][5]. - The safety profile of Lynozyfic raises concerns, with a 12.5% incidence of grade 3-4 infections and a 25% incidence of grade 3-4 neutropenia, alongside a 42% occurrence of any grade cytokine release syndrome [4][5]. Group 2: Johnson & Johnson's Darzalex - The AQUILA trial indicates that Darzalex monotherapy extends progression-free survival (PFS) and overall survival (OS) for high-risk SMM patients, reducing disease progression rates from 41.8% in the observation group to 21.8%. This has led to EU approval and potential FDA approval [8]. - There are concerns regarding the definition of "high-risk" SMM in the AQUILA trial compared to existing SLiM standards, which may hinder the widespread application of Darzalex due to the asymptomatic nature of the disease [8]. Group 3: Patient Identification and Treatment Concerns - The Quiredex trial shows that lenalidomide combined with dexamethasone significantly delays the progression to multiple myeloma, with a PFS of 9.5 years compared to 2.1 years for the control group. However, many physicians remain cautious about early intervention due to overtreatment risks and challenges in accurately identifying high-risk patients [6][8]. - The use of circulating tumor DNA (ctDNA) detection technology is suggested to better identify patients at high risk of progressing to multiple myeloma, aiming to minimize overtreatment [6].

Core Insights - Regeneron Pharmaceuticals, Inc. is a biotechnology company focused on developing medicines for serious diseases, with a market cap of $59.1 billion, and is set to announce its fiscal Q3 earnings for 2025 on October 28 [1] Financial Performance - Analysts expect Regeneron to report a profit of $7.80 per share for Q3 2025, a decrease of 33.5% from $11.73 per share in the same quarter last year [2] - For fiscal 2025, the expected profit is $32.36 per share, down 16.2% from $38.62 per share in fiscal 2024, with a further decline of 2.4% anticipated for fiscal 2026 [3] Stock Performance - Regeneron's stock has declined 44.9% over the past 52 weeks, underperforming compared to the S&P 500 Index's 12.3% return and the Health Care Select Sector SPDR Fund's 8.6% drop [4] - Following a better-than-expected Q2 earnings release, Regeneron's shares surged 2.5%, with overall revenue improving 3.6% year-over-year to $3.7 billion, exceeding analyst expectations by 10.2% [5] Analyst Ratings - Wall Street analysts maintain a "Moderate Buy" rating for Regeneron, with 18 out of 27 analysts recommending "Strong Buy," and a mean price target of $729.85, indicating a potential upside of 29.5% from current levels [6]

Core Viewpoint - Investing in companies that have underperformed but show potential for long-term recovery can yield above-average market returns, exemplified by DexCom and Regeneron Pharmaceuticals, whose shares are down 17% and 21% this year respectively due to company-specific challenges [1]. DexCom - DexCom specializes in continuous glucose monitoring (CGM) systems for diabetes patients, facing challenges such as worse-than-expected financial results and a faster-than-anticipated rebate eligibility impacting revenue [3][4]. - In Q2, DexCom's revenue increased by 15% year-over-year to $1.2 billion, with non-GAAP net earnings per share at $0.48, reflecting an 11.6% increase compared to the previous year, indicating a rebound in financial performance [4]. - The CGM market presents significant growth opportunities, with over 4.5 million insulin patients in the U.S. eligible for coverage but not yet using CGM, and the launch of Stelo as an over-the-counter option for non-insulin patients further expands market potential [6][7]. - DexCom benefits from a network effect due to its large installed base and integration with third-party devices, which could help mitigate tariff threats through a multipronged strategy [7][8]. Regeneron Pharmaceuticals - Regeneron is working to overcome a recent patent cliff, indicating potential for future growth and recovery in its stock performance [8].

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 ...