Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Regeneron Pharmaceuticals due to allegations of misleading statements and violations of federal securities laws related to the pricing and sales of its Eylea drug [2][4]. Group 1: Allegations Against Regeneron - The complaint alleges that Regeneron made false and misleading statements regarding credit card fee payments to distributors, which were not disclosed as price concessions [4]. - It is claimed that these undisclosed payments led to inflated reported sales of Eylea and overstated average selling prices (ASP) reported to federal agencies, violating the False Claims Act [4][5]. - The U.S. Department of Justice filed a complaint against Regeneron, alleging that the company failed to report millions in discounts, resulting in inflated Medicare reimbursements [5]. Group 2: Financial Impact - Following the DOJ announcement, Regeneron's stock price fell by $31.50, or 3.36%, closing at $904.70 on April 12, 2024, with unusually heavy trading volume [6]. - On October 31, 2024, Regeneron reported a 3% increase in U.S. net sales for Eylea compared to Q3 2023, with Eylea HD sales of $392 million, missing consensus estimates of $415 million to $425 million [7]. - The stock price dropped by $84.59, or 9.2%, to close at $838.20 per share on the same day due to weaker-than-expected quarterly sales [7]. Group 3: Legal Proceedings - Investors who suffered losses exceeding $100,000 in Regeneron between November 2, 2023, and October 30, 2024, are encouraged to contact Faruqi & Faruqi to discuss their legal options [1]. - There is a March 10, 2025, deadline for investors to seek the role of lead plaintiff in the federal securities class action against Regeneron [2]. - The lead plaintiff is defined as the investor with the largest financial interest who directs and oversees the litigation on behalf of the class [8].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Regeneron Pharmaceuticals, Inc. regarding a class action lawsuit alleging misleading statements and omissions related to the pricing and sales of Eylea, a primary product of the company [1]. Allegations Summary - The lawsuit claims that Regeneron made materially false and misleading statements by failing to disclose payments made to distributors to cover credit card fees, which affected the pricing of Eylea [1]. - It is alleged that these undisclosed payments led to a price concession that lowered Eylea's selling price, providing a competitive advantage in the market [1]. - The complaint further asserts that Regeneron overstated the average selling price (ASP) reported to federal agencies, violating the False Claims Act, and that positive statements about the company's business were misleading [1]. Class Action Details - The class period for the lawsuit is defined as November 2, 2023, to October 30, 2024, with a deadline for shareholders to register for participation set for March 10, 2025 [2]. - Shareholders who register will receive updates on the case's progress and can seek to be appointed as lead plaintiff without any cost or obligation [2]. Firm's Mission - The Gross Law Firm aims to protect investors' rights and ensure companies adhere to responsible business practices, seeking recovery for losses incurred due to misleading statements or omissions [3].

Core Viewpoint - A class action lawsuit has been filed against Regeneron Pharmaceuticals, Inc. for allegedly misleading investors about its business prospects during the period from November 2, 2023, to October 30, 2024 [1][2]. Allegations - The lawsuit claims that Regeneron failed to disclose several key points, including: - Payments made to distributors to cover credit card fees, which were contingent on not charging Eylea customers more for credit card use [2] - These payments effectively subsidized the prices for customers using credit cards to purchase Eylea [2] - The price concessions led to a lower selling price for Eylea [2] - Retina practices were sensitive to higher prices for anti-VEGF medications, giving Regeneron a competitive advantage through these concessions [2] - The misleading reporting of Eylea sales due to these undisclosed payments [2] - Overstated Average Selling Price (ASP) reported to federal agencies, violating the False Claims Act [2] - Positive statements made by the company regarding its business and prospects were materially misleading [2] Next Steps for Investors - Shareholders interested in serving as lead plaintiffs must submit their applications by March 4, 2025 [3]. - Investors can choose to remain absent class members and still be eligible for recovery without participating in the case [3]. Company Background - Robbins LLP is a recognized leader in shareholder rights litigation, dedicated to helping shareholders recover losses and improve corporate governance since 2002 [4].

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 Insights - The FDA has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of bullous pemphigoid (BP) under priority review [1][5][10] - Dupixent has shown significant efficacy in a pivotal study, with five times more patients achieving sustained disease remission compared to placebo [2][10] - BP is a chronic skin disease affecting approximately 27,000 adults in the US, characterized by severe itching and blisters [4][10] Group 1: Dupixent's Efficacy and Safety - The pivotal study involved 106 adults with moderate-to-severe BP, meeting its primary endpoint [2] - Dupixent significantly reduced disease severity, itch, and the use of oral corticosteroids compared to placebo [2] - Common adverse events associated with Dupixent included peripheral edema, arthralgia, and hypertension [3] Group 2: Regulatory and Market Context - Priority review is granted for therapies that may offer significant improvements in treating serious conditions [5] - Dupixent has received orphan drug designation for BP, indicating its potential impact on a rare disease affecting fewer than 200,000 people in the US [5] - If approved, Dupixent would be the first targeted treatment for BP in the US, with an FDA decision expected by June 20, 2025 [10] Group 3: Dupixent Development and Applications - Dupixent is a fully human monoclonal antibody targeting interleukin-4 and interleukin-13 pathways, not classified as an immunosuppressant [7] - The drug has received regulatory approvals in over 60 countries for various indications, with more than one million patients treated globally [8] - Dupilumab is being developed by Sanofi and Regeneron, with ongoing studies for additional diseases driven by type-2 inflammation [9][10]

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 ...