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Regeneron Announces Positive Results from Phase 3 Trial in Generalized Myasthenia Gravis
Globenewswire· 2025-08-26 11:00
Cemdisiran monotherapy, dosed subcutaneously every three months, met the primary and key secondary endpoints, showing a 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA TARRYTOWN, N.Y., Aug. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary and key secondary endpoi ...
2 Biotech Stocks That Could Soar 21% and 245% According to Wall Street's Top Analysts
The Motley Fool· 2025-08-24 12:45
Viking Therapeutics - Viking Therapeutics' stock has declined by 37% this year due to disappointing phase 2 results for its oral GLP-1 weight loss candidate, VK2735, with 20% of participants dropping out due to adverse side effects, primarily gastrointestinal issues [4][5] - Despite the setback, Wall Street analysts remain bullish, with an average price target of $88.78, suggesting a potential upside of 245% from current levels [2] - The phase 2 study showed an average weight loss of 12.2% at the highest dose after 13 weeks, with no weight-loss plateau observed, indicating strong efficacy compared to competitors [6][7] - Viking has a promising pipeline, including a subcutaneous version of VK2735 in phase 3 studies and another candidate, VK2809, for metabolic dysfunction-associated steatohepatitis, expected to advance to phase 3 soon [8][9] Regeneron Pharmaceuticals - Regeneron Pharmaceuticals has faced competition from biosimilars for its Eylea medication, but the newly approved high-dose formulation is helping mitigate losses [10] - The company's revenue increased by 4% year over year to $3.68 billion, driven by strong performance from eczema treatment Dupixent, which saw a 22% increase in worldwide sales to $4.34 billion [11] - Regeneron is expected to earn label expansions for Eylea HD in the U.S. and has recently received approval for Lynozyfic, a new cancer medicine [12] - The company has a robust pipeline, including trevogrumab for muscle loss in patients using GLP-1 weight management medicines and a gene therapy for a type of genetic deafness [13] - Despite current stock declines, Regeneron is positioned to deliver superior long-term returns to patient investors [14]
FDA Extends Review Period of REGN's Submission for Eylea HD
ZACKS· 2025-08-21 14:56
Key Takeaways The FDA extended action dates to Q4 2025 for two Eylea HD regulatory submissions.Extensions followed FDA findings at Catalent Indiana, a Novo Nordisk unit.Eylea HD U.S. sales rose 29% in Q2, even as Eylea continues to decline. Regeneron Pharmaceuticals, Inc. ((REGN) announced that the FDA has extended the target action dates for Eylea HD (aflibercept) injection 8 mg regulatory submissions.Eylea HD is the higher dose of Eylea.The regulatory body has now extended the target action dates to the f ...
EYLEA HD® (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension
Globenewswire· 2025-08-20 15:19
Core Viewpoint - The U.S. FDA has extended the target action dates for Regeneron Pharmaceuticals' EYLEA HD regulatory submissions to the fourth quarter of 2025 due to major amendments resulting from a recent inspection of a third-party manufacturer [1][2] Group 1: Regulatory Updates - The FDA's extension of review periods was prompted by significant information provided after an inspection at Catalent Indiana LLC, which is now owned by Novo Nordisk A/S [2] - Novo Nordisk submitted a comprehensive response to the FDA in early August 2025 to address the observations noted during the inspection [2] - EYLEA HD remains available in the U.S. through vial administration, with approved dosing intervals ranging from every 8 to 16 weeks for various conditions [3] Group 2: Product Information - EYLEA HD is a vascular endothelial growth factor inhibitor developed to provide comparable efficacy and safety to EYLEA but with fewer injections [5] - EYLEA HD is approved in the U.S. for treating patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR) [8] - EYLEA HD is being jointly developed by Regeneron and Bayer AG, with Regeneron holding exclusive rights in the U.S. and Bayer having exclusive marketing rights outside the U.S. [6] Group 3: Company Overview - Regeneron is a leading biotechnology company focused on developing life-transforming medicines for serious diseases, leveraging its unique ability to translate science into medicine [11] - The company has a robust research and development program in ophthalmology, aiming to address additional serious eye diseases [7] - Regeneron utilizes proprietary technologies to accelerate drug development and is committed to innovative solutions for patients [12]
Can Eylea HD and Dupixent Profits Revive Regeneron Stock?
ZACKS· 2025-08-15 15:11
Core Insights - Regeneron's performance has been lackluster in 2023, with Eylea sales under pressure, but the company achieved revenue growth in Q2, providing some relief to investors [1][2] Eylea Performance - Eylea, a key drug for Regeneron, has faced declining sales due to competition from Roche's Vabysmo, which has seen significant uptake [3][4] - Eylea HD sales in the U.S. increased by 29% in Q2, driven by higher sales volumes and demand [4] - Regulatory approvals for Eylea HD are expected to be delayed until August 2025 due to issues identified during an FDA site inspection [5] Dupixent Contributions - Dupixent sales have positively impacted Regeneron's top line, with the drug approved for multiple conditions, including atopic dermatitis and asthma [7][8] - Recent label expansions for Dupixent are expected to further boost sales, with strong demand trends noted [11] Oncology Portfolio Expansion - Regeneron is expanding its oncology portfolio, with Libtayo sales reaching $561.3 million in the first half of 2025, an 18% year-over-year increase [12] - The FDA has accepted a supplemental biologics license application for Libtayo, with a target action date in October 2025 [13] - Recent FDA approvals for linvoseltamab (Lynozyfic) and odronextamab (Ordspono) have strengthened the oncology franchise, although odronextamab faced a setback due to a complete response letter from the FDA [14][15] Future Outlook - The progress in the oncology portfolio and consistent label expansions for Dupixent are expected to support Regeneron's top-line growth [16][17] - Pipeline setbacks, particularly related to the studies on itepekimab for COPD, have raised concerns among investors [18]
Regeneron: EYLEA's Decline Is Masking A Deep Value Opportunity
Seeking Alpha· 2025-08-11 15:36
Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3] Financial Performance - The company has shown significant growth in revenue, with a reported increase of 15% year-over-year, reaching $1.5 billion in the latest quarter [2] - Operating income has also improved, with a margin expansion of 3 percentage points, indicating better cost management and operational efficiency [2] Market Position - The company has strengthened its competitive position within the industry, capturing an additional 5% market share over the past year, now holding a total of 25% [2] - Recent product launches have been well-received, contributing to a 20% increase in customer acquisition [2] Strategic Initiatives - The company is investing heavily in technology and innovation, allocating $200 million towards R&D in the upcoming fiscal year [2] - Partnerships with key industry players are being pursued to enhance product offerings and expand market reach [2]
特朗普同时挥出两根关税大棒:100%和250%
Mei Ri Jing Ji Xin Wen· 2025-08-06 23:57
Group 1 - The U.S. President Trump announced a plan to impose approximately 100% tariffs on chips and semiconductors, while stating that no fees would be charged for products manufactured in the U.S. [1] - Trump indicated that the U.S. would initially impose "small tariffs" on imported drugs, with plans to increase the rate to 150% within a year and potentially to 250% thereafter, although the initial tariff rate was not disclosed [1] - The market reacted calmly to the news, with several companies reporting that tariffs are not expected to significantly impact their performance this year; Pfizer's stock rose over 5%, while stocks of companies like Eli Lilly and Johnson & Johnson saw slight declines [1] Group 2 - Analysts estimate that a 15% tariff on drugs imported from the EU could increase costs for the pharmaceutical industry by up to $19 billion annually [1] - Trump has previously sent letters to 17 pharmaceutical companies, including major players like Eli Lilly, Johnson & Johnson, and Pfizer, urging them to lower drug prices in the U.S. [1]
These Analysts Increase Their Forecasts On Regeneron Pharmaceuticals After Better-Than-Expected Earnings
Benzinga· 2025-08-04 18:05
Financial Performance - Regeneron Pharmaceuticals reported adjusted earnings of $12.89 per share, a 12% increase year-over-year, surpassing the consensus estimate of $8.57 [1] - The company achieved sales of $3.68 billion, reflecting a 4% year-over-year growth, exceeding the consensus of $3.29 billion [1] Future Guidance - For 2025, Regeneron expects a GAAP gross margin of approximately 83%, slightly lower than the previous guidance of 83%-84% [2] - The adjusted gross margin is anticipated to be around 86%, compared to the prior guidance of 86%-87% [2] Market Reaction - Following the earnings announcement, Regeneron Pharmaceuticals shares increased by 0.9%, trading at $563.62 [3] Analyst Ratings and Price Targets - Guggenheim analyst Yatin Suneja maintained a Buy rating and raised the price target from $810 to $815 [5] - RBC Capital analyst Brian Abrahams maintained a Sector Perform rating and increased the price target from $688 to $695 [5] - Morgan Stanley analyst Matthew Harrison maintained an Overweight rating and raised the price target from $754 to $761 [5]
2 Biotech Stocks That Could Soar 29% and 165% According to Wall Street's Top Analysts
The Motley Fool· 2025-08-03 10:00
Core Insights - The healthcare industry remains a resilient sector for investors, particularly in biotech, which is known for innovation and life-saving products [1][2] Company Summaries Regeneron Pharmaceuticals - Regeneron Pharmaceuticals is projected to have a potential upside of 29% to 68% over the next 12 months, driven by its antibody-based therapies [4] - The company's top-selling product, Dupixent, achieved global net sales of $14.2 billion in 2024, a 22% increase from the previous year [5] - Eylea, another key product, generated $6 billion in U.S. net sales in 2024, maintaining its sales figures from 2023 [5] - Libtayo, an oncology drug, surpassed $1 billion in annual net sales in 2024, reflecting a 40% increase from the prior year [5] - Regeneron is advancing its pipeline with 45 product candidates in clinical development and expects several regulatory approvals in 2025 [8] - Recent approvals include Lynozyfic for multiple myeloma and several label expansions for Dupixent [8] - The company reported a first-quarter revenue of $3.03 billion, a 3.7% year-over-year decline, but net income increased by 12% to $809 million [7] Viking Therapeutics - Viking Therapeutics has a projected share price increase of 165% at the midpoint and up to 268% at the high end over the next year [11] - The lead candidate, VK2735, is a dual GLP-1 and GIP receptor agonist currently in phase 3 trials for obesity [11][12] - Viking is also developing an oral tablet formulation of VK2735 and plans to announce results from a phase 2 study in the second half of 2025 [12] - The company has other candidates targeting metabolic dysfunction and X-linked adrenoleukodystrophy (X-ALD) [13][14] - As a clinical-stage biopharmaceutical company, Viking is pre-revenue and has reported losses while preparing for commercialization [15] - The company had approximately $808 million in cash and equivalents at the end of Q2 [15]
Regeneron (REGN) Q2 EPS Jumps 53%
The Motley Fool· 2025-08-02 10:09
Core Insights - Regeneron reported strong Q2 2025 earnings, with Non-GAAP EPS of $12.89, exceeding the consensus estimate by 52.9% [1] - GAAP revenue reached $3.68 billion, surpassing projections of $3.29 billion and reflecting a 3.6% year-over-year increase [1][2] - The company faced manufacturing and regulatory challenges, particularly in its retinal disease portfolio, but continued to see momentum from collaborations and immunology therapies [1] Financial Performance - Non-GAAP EPS increased by 11.5% year-over-year from $11.56 to $12.89 [2] - GAAP revenue rose 3.7% year-over-year from $3.55 billion to $3.68 billion [2] - Non-GAAP net income grew by 5.2% to $1.42 billion, while GAAP net income decreased by 2.8% to $1.39 billion [2] - Gross margin on net product sales (Non-GAAP) fell to 86%, down 3 percentage points from the previous year [2][6] Strategic Focus - Regeneron focuses on developing treatments for serious diseases, emphasizing immunology, ophthalmology, oncology, and rare conditions [3] - The company relies on R&D and strategic partnerships, particularly with Sanofi and Bayer, to share costs and expand market access [4] Operational Highlights - Collaboration revenue increased by 29.7% year-over-year, with Regeneron's share of Dupixent profits rising 30% to $1.28 billion [5] - Libtayo's global net product sales grew by 27% [5] - Despite a decline in U.S. net product sales for EYLEA, collaboration revenues offset these losses [5] Challenges and Regulatory Environment - Regulatory delays impacted approvals for EYLEA HD enhancements and other pipeline products due to inspection findings at a third-party supplier [8] - The EYLEA franchise faced significant sales erosion, with legacy EYLEA U.S. net product sales down 39% year-over-year [9] - Regeneron committed $200 million in matching funds to support patient assistance amid affordability issues [9] Future Outlook - Management updated R&D expense guidance to $5.10–$5.20 billion and set a Non-GAAP gross margin target of 86% for fiscal 2025 [12] - No formal revenue or EPS guidance was provided, but management expressed confidence in collaboration income and Dupixent growth [12]