Dupixent Updates - Dupixent is now used to treat over a million patients globally, with continued growth in multiple indications for diseases involving type 2 inflammation [1][3] - The recent approval and launch in chronic obstructive pulmonary disease (COPD) has secured coverage from top commercial and Medicare payers, addressing approximately 300,000 patients in the US [3] - Continued growth potential exists in additional indications, including chronic spontaneous urticaria (CSU) with an FDA decision expected by April 18, 2025, and bullous pemphigoid, for which a supplemental Biologics License Application (sBLA) was submitted in Q4 2024 [3] EYLEA and EYLEA HD Updates - EYLEA HD and EYLEA remained the US anti-VEGF category leader in 2024, with aggregate US net product sales of $6 billion, up 1% year-over-year [1][40] - Combined US net product sales for Q4 2024 were $1.5 billion, with EYLEA HD contributing $305 million and EYLEA contributing $1.19 billion [40][45] - The company filed an application with the FDA for the EYLEA HD pre-filled syringe (PFS), with approval and launch expected by mid-2025 [1][12] Libtayo Updates - Libtayo exceeded $1 billion in annual net sales for 2024, becoming the first and only immunotherapy to show a statistically significant clinical benefit as adjuvant therapy in high-risk cutaneous squamous cell carcinoma (CSCC) [1][12] - A Phase 3 study demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo in high-risk CSCC patients [12] Pipeline and R&D Highlights - The company has approximately 40 investigational candidates in its pipeline, covering dozens of disease states with expansive market potential [1] - The total addressable commercial market for advanced pipeline programs is expected to exceed $220 billion by 2030 [12] - Key pipeline candidates include itepekimab (IL-33) for COPD, fianlimab (LAG3) for melanoma, linvoseltamab (BCMAxCD3) for multiple myeloma, and odronextamab (CD20xCD3) for lymphoma [12] Genetics and Data-Driven Innovation - The Regeneron Genetics Center has sequenced nearly three million people with de-identified linked healthcare records [6] - A strategic collaboration with Truveta, Inc is expected to expand the DNA-linked healthcare database to include sequencing and linked Electronic Health Records for up to 10 million additional individuals [6] - The company was selected by UK BioBank consortium members to complete proteomic assay data generation for the UK Biobank Pharma Proteomics Project [6]

Clinical Trial Results - Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death in high-risk CSCC patients compared to placebo, meeting the primary endpoint of DFS at the first prespecified interim analysis [1][2] - The Phase 3 C-POST trial enrolled 415 patients with high-risk CSCC, randomized to receive Libtayo or placebo for up to 48 weeks, with a median follow-up duration of 24 months [2] - Libtayo is the first and only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting, following a recent Phase 3 trial with Keytruda that failed in the same setting [1] Safety Profile - Adverse events of any grade occurred in 91% of patients in the Libtayo arm and 89% in the placebo arm, with Grade ≥3 AEs occurring in 24% and 14% of patients, respectively [3] - Treatment discontinuations due to adverse reactions occurred in 10% of patients in the Libtayo arm and 1.5% in the placebo arm, with two patients experiencing an AE leading to death in each arm [3] Regulatory and Market Impact - Libtayo is already the standard of care for certain patients with advanced CSCC and has been approved in more than 30 countries for various indications, including advanced BCC, CSCC, NSCLC, and cervical cancer [5][25] - The company plans to submit the trial results to the U.S. FDA in the first half of 2025, with detailed results to be presented at an upcoming medical meeting [20] Company Background and Technology - Regeneron's VelocImmune technology, which utilizes a genetically engineered mouse platform, was instrumental in developing Libtayo and other FDA-approved fully human monoclonal antibodies [26] - The company's oncology strategy includes a robust pipeline with nearly half of its assets in clinical development, focusing on checkpoint inhibitors, bispecific antibodies, and costimulatory bispecific antibodies [16] Trial Design and Methodology - The C-POST trial is a randomized, placebo-controlled, double-blind, multicenter Phase 3 study investigating Libtayo as adjuvant treatment for high-risk CSCC patients who have completed surgery and post-operative radiation therapy [22] - The trial design includes a primary endpoint of DFS and secondary endpoints such as freedom from locoregional recurrence, freedom from distant recurrence, overall survival, and cumulative incidence of second primary CSCC tumors [24]

Strategic Collaboration and Investment - Regeneron Pharmaceuticals announced a strategic collaboration with Truveta Inc and its collective of US health systems to advance innovation and data-driven discovery across life sciences, public health, and healthcare delivery [1] - Regeneron will invest $119.5 million in Truveta's Series C financing round and collaborate to launch the Truveta Genome Project, aiming to sequence up to ten million additional de-identified patient volunteers with linked electronic health records (EHRs) [1] - The Truveta Genome Project will extend Regeneron's DNA sequence-linked healthcare database, which currently includes nearly three million de-identified patient volunteers, to unlock insights into how genetics impact health and potentially lead to new genetic-based therapies [1][4] Project Goals and Impact - The Truveta Genome Project aims to dramatically accelerate the discovery of new genetics-based drug targets and therapies, while empowering healthcare analytics and management [4] - The project will integrate genotypic data from up to ten million de-identified consented volunteers with Truveta's medical database, representing over 120 million patients across 30 health systems, to yield actionable insights for drug development and healthcare delivery [3] - Regeneron's RGC will have exclusive rights to perform all research-related sequencing on samples collected under the collaboration and access to de-identified EHR data provided by study participants [6][7] Industry and Scientific Advancements - The collaboration combines Regeneron's expertise in genetics and drug development with Truveta's extensive phenotypic data and collaboration of leading US health systems to create a 'Big Data' resource for next-generation drug discovery and healthcare management [8] - Regeneron's RGC has already identified dozens of genetic-based drug targets for conditions such as chronic liver disease, obesity, cancer, and neurodegenerative conditions, leading to multiple clinical-stage medicines [3] - Illumina Inc, a global leader in DNA sequencing, will also invest $20 million in Truveta's Series C financing round to support the Truveta Genome Project [2] Company Background - Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for serious diseases, with a focus on eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases [9] - The company leverages proprietary technologies like VelociSuite to produce optimized fully human antibodies and new classes of bispecific antibodies, shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center [10] - The Regeneron Genetics Center (RGC) is a genomic research initiative that has harnessed human genetics for over a decade to discover new medicines, validate research programs, and optimize clinical trials, with a database of over 2.6 million sequenced exomes [12]

NEW YORK, Jan. 13, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).Shareholders who purchased shares of REGN during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/regeneron-pharmaceuticals-inc-loss-submission-form/?id=122003&from=4CLASS ...

SAN DIEGO, Jan. 10, 2025 /PRNewswire/ -- The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) securities between November 2, 2023 and October 30, 2024, inclusive (the "Class Period"), have until March 10, 2025 to seek appointment as lead plaintiff of the Regeneron class action lawsuit.  Captioned Radtke v. Regeneron Pharmaceuticals, Inc., No. 25-cv-00145 (S.D.N.Y.), the Regeneron class action lawsuit charges Regeneron and c ...

If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider Regeneron (REGN) . This company, which is in the Zacks Medical - Biomedical and Genetics industry, shows potential for another earnings beat.This biopharmaceutical company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters wa ...

LOS ANGELES, Jan. 10, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Regeneron Pharmaceuticals, Inc. ("Regeneron" or "the Company") (NASDAQ: REGN) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.Investors who purchased the Company's securities between November 2, 2023 and October 30, 2024, inclusive (the ...

NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Attorney Advertising-- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Regeneron Pharmaceuticals, Inc. (“Regeneron” or “the Company”) (NASDAQ: REGN) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acqu ...

SAN FRANCISCO, Jan. 9, 2025 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) faces a securities fraud class action after shares of the company plunged $84.59 on Oct. 31, 2024, wiping out about $9 billion of market value.Hagens Berman has opened an investigation into whether Regeneron may have misled investors about its marketing and reimbursement practices related to its EYLEA® product, an injection to treat age-related macular degeneration by inhibiting anti vascular endothelial growth factor ...

NEW YORK, Jan. 08, 2025 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all persons or entities who purchased or otherwise acquired Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) (NASDAQ: REGN) securities between November 2, 2023 and October 30, 2024, inclusive (the “Class Period”). The lawsuit seeks to recover damages for the Company’s investor ...