Core Viewpoint - Regeneron Pharmaceuticals reported strong fourth-quarter and full-year 2024 earnings, exceeding analyst estimates, and announced its initiation of a quarterly dividend, leading to a 5% increase in its stock price [1][2]. Financial Performance - Regeneron's revenue increased by 10% year over year to $3.79 billion, with combined U.S. sales of Eylea and Eylea HD reaching $1.5 billion, a 2% increase from the previous year [9]. - The company initiated a quarterly dividend of $0.88 per share, resulting in a forward dividend yield of 0.50% [3][4]. Competitive Position - Regeneron's dividend per share is competitive compared to other major biotech and pharmaceutical companies, although it is still early in its dividend-paying journey [2][3]. - The company faces competition for Eylea from Roche and biosimilar challenges from Amgen's Pavblu, but it is ramping up Eylea HD, which offers more dosing flexibility [7][10]. Growth Drivers - Dupixent, Regeneron's eczema treatment, saw fourth-quarter global sales increase by 15% year over year to $3.7 billion, with analysts projecting potential annual sales of $20 billion due to a new COPD indication [11][12]. - Regeneron has a robust pipeline with several dozen programs aimed at expanding its oncology presence, which is expected to lead to significant approvals in the future [12]. Capital Allocation - The company announced an increase in its share repurchase capacity by $3 billion to $4.5 billion, indicating a preference for share buybacks over dividend increases [13][14]. - Management emphasizes that share repurchases will remain the primary method of returning capital to shareholders, although there is potential for future dividend increases [14].

Core Viewpoint - Dupixent (dupilumab) is under Priority Review by the FDA for the treatment of bullous pemphigoid (BP), with a decision expected by June 20, 2025, potentially making it the first targeted therapy for BP in the U.S. [1][5] Group 1: Drug Efficacy and Clinical Trials - The supplemental Biologics License Application (sBLA) for Dupixent is supported by a pivotal trial involving 106 adults with moderate-to-severe BP, where Dupixent patients achieved sustained disease remission five times more than those on placebo [2] - Sustained disease remission was defined as complete clinical remission with the tapering of oral corticosteroids by week 16, without relapse or rescue therapy during the 36-week treatment period [2] - The trial demonstrated significant reductions in disease severity, itch, and the use of oral corticosteroids compared to placebo [2] Group 2: Disease Background and Patient Population - Bullous pemphigoid is a chronic, debilitating skin disease characterized by intense itching, blisters, and painful lesions, primarily affecting an elderly population [4] - Approximately 27,000 adults in the U.S. suffer from uncontrolled BP despite systemic corticosteroid treatment [4] Group 3: Regulatory Status and Designations - Dupixent has been granted Priority Review by the FDA, which is reserved for therapies that show potential for significant improvements in treating serious conditions [5] - The drug previously received Orphan Drug Designation for BP, indicating its intended use for a rare disease affecting fewer than 200,000 people in the U.S. [5] Group 4: Safety Profile - Common adverse events associated with Dupixent include peripheral edema, arthralgia, back pain, and upper respiratory tract infections, among others [3]

Core Insights - Allka Research has over two decades of experience in investment, focusing on uncovering undervalued assets in ETFs, commodities, technology, and pharmaceutical sectors [1] - The company emphasizes a conservative investment approach, aiming to deliver substantial returns and strategic insights to clients [1] - Allka Research is committed to simplifying investment strategies, making them accessible to both seasoned and novice investors [1] Company Mission - The mission of Allka Research is to empower individuals financially by sharing knowledge and insights through the Seeking Alpha platform [1] - The company aims to provide thought-provoking analyses and informed perspectives to foster a community of informed investors [1] - Allka Research seeks to demystify investing, inspiring confidence in readers to navigate the markets intelligently [1]

Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at least four prior lin ...

NEW YORK, Feb. 11, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company") (NASDAQ: REGN) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Regeneron investors who were adversely affected by alleged securities fraud between November 2, 2023 and October 30, 2024. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/regeneron-ph ...

NEW YORK, Feb. 10, 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=127844&from=4 CLAS ...

TARRYTOWN, N.Y., Feb. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions. The data were presented today at the virtual Angiogenesis (Angiogenesis, Exudation, and Degeneration) 2025 annual ...

At three years of EYLEA HD treatment, the vast majority of patients maintained visual and anatomic improvements while achieving extended dosing regimens, including those of just twice a year: 77%, 58%, 40% and 24% achieved last assigned dosing intervals of ≥3, ≥4, ≥5 and 6 months, respectively At three years, the vast majority of patients who switched to EYLEA HD from a fixed 2-month dosing regimen with EYLEA® (aflibercept) Injection 2 mg maintained visual and anatomic improvements while rapidly extending t ...

NEW YORK, Feb. 7, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company") (NASDAQ: REGN) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Regeneron investors who were adversely affected by alleged securities fraud between November 2, 2023 and October 30, 2024. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/regeneron-pha ...

NEW YORK, Feb. 6, 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=127270&from=4 CLASS ...