Core Viewpoint - Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma who have undergone at least three prior therapies [1][2] Summary by Sections Clinical Development - Linvoseltamab is an investigational bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, designed to activate T-cells to kill cancer cells [4] - The pivotal LINKER-MM1 trial involved 282 patients with relapsed and refractory multiple myeloma, focusing on safety, tolerability, and anti-tumor activity [5][6] - The trial's primary endpoint is the objective response rate, with secondary endpoints including duration of response and overall survival [5] Regulatory Status - The FDA has accepted the Biologics License Application for linvoseltamab, with a target action date set for July 10, 2025 [2] - The European Commission is expected to make a final decision regarding the marketing authorization in the coming months [1] Disease Context - Multiple myeloma is the second most common blood cancer, with over 35,000 new cases diagnosed annually in Europe and 187,000 globally [3] - The disease is characterized by the proliferation of cancerous plasma cells, leading to severe health complications [3] Treatment Landscape - Current treatments for multiple myeloma are not curative, and most patients will eventually require additional therapies due to disease progression [3] - Linvoseltamab is being evaluated not only as a monotherapy but also in combination with other treatments across various lines of therapy [7]

NEW YORK, Feb. 28, 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 ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $100,000 In Regeneron To Contact Him Directly To Discuss Their OptionsIf you suffered losses exceeding $100,000 in Regeneron between November 2, 2023 and October 30, 2024 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).[You may also click here for additional information]NEW YORK, Feb. 27, 2025 /PRN ...

Core Viewpoint - Regeneron Pharmaceuticals has resubmitted the Biologics License Application (BLA) for odronextamab to the FDA for the treatment of relapsed/refractory follicular lymphoma, with a decision expected by July 30, 2025 [1][2]. Group 1: FDA Review and Clinical Trials - The FDA accepted the BLA resubmission after Regeneron met the enrollment target for the Phase 3 trial (OLYMPIA-1), which was the only issue identified in the previous submission [2]. - Data from Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2) showed an overall response rate of 80% (n=103), with 74% (n=95) achieving a complete response [2]. - Serious adverse events were reported in 67% of patients, with cytokine release syndrome, COVID-19, and pneumonia being the most common [2]. Group 2: Product Information and Market Context - Odronextamab is already approved in the EU as Ordspono™ for treating R/R FL or diffuse large B-cell lymphoma after two or more lines of therapy [3]. - Follicular lymphoma (FL) is a common subtype of B-cell non-Hodgkin lymphoma, with approximately 122,000 cases diagnosed globally each year and over 13,600 cases expected in the U.S. in 2025 [4]. Group 3: Clinical Development Program - The clinical development program for odronextamab includes ongoing trials (ELM-1 and ELM-2) investigating its safety and efficacy across various B-NHL subtypes [5][6]. - The primary endpoint for these trials is the objective response rate, with secondary endpoints including complete response and overall survival [6]. - Odronextamab is being evaluated both as a monotherapy and in combination with other therapies in multiple Phase 3 trials [7]. Group 4: Company Overview - Regeneron is a leading biotechnology company focused on developing medicines for serious diseases, leveraging over three decades of expertise in biology and proprietary technologies [12][13]. - The company is known for its innovative approaches in blood cancer research, particularly in bispecific antibodies and other therapeutic modalities [9].

SAN DIEGO, Feb. 25, 2025 /PRNewswire/ -- 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, both dates inclusive (the "Class Period"), have until Monday, 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 as ...

Core Viewpoint - The Rosen Law Firm is reminding investors who purchased Regeneron Pharmaceuticals, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline for a class action lawsuit [1][2]. Group 1: Class Action Details - Investors who purchased Regeneron securities between November 2, 2023, and October 30, 2024, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by March 10, 2025 [3]. - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. Group 2: Allegations Against Regeneron - The lawsuit alleges that Regeneron made false and misleading statements regarding its business practices, particularly related to its product Eylea [5]. - Specific allegations include that Regeneron paid credit card fees to distributors to prevent them from charging customers more for using credit cards, which effectively subsidized the prices for Eylea [5]. - The lawsuit claims that these actions misled investors about the true sales figures and pricing strategies of Regeneron, resulting in damages when the true information was revealed [5].

Core Insights - Regeneron Pharmaceuticals Inc. is experiencing significant challenges, including disappointing sales, legal issues, and analyst downgrades [1][2] - TD Cowen has reduced its price target for Regeneron from $1,230 to $1,030 due to increased competition and lower revenue expectations for EYLEA® [1] Sales Performance - Regeneron reported only a 3% year-over-year increase in U.S. net sales for EYLEA® and EYLEA HD® in Q3 2024, attributing the underperformance to lower net selling prices and pricing pressure in the anti-VEGF category [6] Legal Challenges - The company is involved in a securities fraud class action lawsuit related to a significant stock price drop on October 31, 2024, which resulted in a loss of approximately $9 billion in market capitalization [2] - The lawsuit alleges that Regeneron made false statements regarding Medicare reimbursement rules for EYLEA® and failed to disclose credit card fee payments to distributors, which allegedly inflated reported sales figures [3][4] Regulatory Issues - The Department of Justice has filed a lawsuit against Regeneron for alleged violations of the False Claims Act, claiming the company fraudulently inflated Medicare reimbursement rates by submitting false Average Sales Price (ASP) reports [5] - The undisclosed price concessions related to credit card processing fees are central to the allegations, suggesting that Regeneron misrepresented its revenue reporting [7]

Core Insights - Regeneron Pharmaceuticals announced updated data for its investigational gene therapy DB-OTO, showing significant improvements in hearing among children with profound genetic hearing loss due to otoferlin gene variants [1][6][12] - The Phase 1/2 CHORD trial demonstrated that 10 out of 11 children assessed post-treatment exhibited notable hearing improvements, with some achieving near-normal hearing levels [3][4] Group 1: Trial Results - The first participant in the trial showed improvement in hearing to near-normal levels across key speech frequencies, with positive auditory brainstem responses corroborating these findings [3] - Among the 11 participants with at least one post-treatment assessment, 10 demonstrated improved hearing at various decibel levels, with three out of five participants showing significant improvements in average hearing thresholds [4] - The first child treated at 10 months of age exhibited progress in speech and development, highlighting the therapy's potential impact on quality of life [1][2] Group 2: Safety and Tolerability - The surgical procedure for administering DB-OTO was well tolerated, with no serious adverse events related to the therapy reported [5] - Five participants experienced transient vestibular adverse events post-surgery, which resolved within six days [5] Group 3: Regulatory Designations - DB-OTO has received multiple designations from the U.S. FDA, including Orphan Drug and Fast Track designations, indicating its potential significance in treating rare pediatric diseases [6] - The investigational therapy is currently under clinical investigation, with its safety and efficacy not yet evaluated by regulatory authorities [6] Group 4: Background on Hearing Loss - Congenital deafness affects approximately 1.7 out of every 1,000 children born in the U.S., with genetic causes accounting for about half of these cases [7] - Otoferlin-related hearing loss is ultra-rare and results from variants in the OTOF gene, leading to a lack of functional otoferlin protein essential for auditory nerve communication [7] Group 5: CHORD Trial Overview - The CHORD trial is a Phase 1/2, multicenter, open-label study evaluating the safety, tolerability, and preliminary efficacy of DB-OTO in children with otoferlin variants [8][9] - The trial is currently enrolling participants across the U.S., U.K., and Spain, with a focus on infants, children, and adolescents [9]

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 during the class period from November 2, 2023, to October 30, 2024 [1]. - Specific allegations include that Regeneron paid credit card fees to distributors to prevent them from charging higher prices to Eylea customers using credit cards, which effectively subsidized the prices for these customers [1]. - It is alleged that these actions led to a price concession that lowered Eylea's selling price, providing a competitive advantage in a sensitive pricing environment for retina practices [1]. - The complaint asserts that Regeneron misrepresented Eylea sales figures and overstated the Average Selling Price (ASP) reported to federal agencies, violating the False Claims Act [1]. Next Steps for Shareholders - Shareholders who purchased shares of Regeneron during the specified class period are encouraged to register for the class action by March 10, 2025, to potentially be appointed as lead plaintiffs [2]. - Registration will include enrollment in a portfolio monitoring software to provide updates throughout the case lifecycle [2]. Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and illegal business practices [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements or omissions [3].

Core Viewpoint - A class action securities lawsuit has been filed against Regeneron Pharmaceuticals, alleging securities fraud that affected investors between November 2, 2023, and October 30, 2024 [1][2]. Group 1: Allegations of Fraud - The lawsuit claims that Regeneron made false statements regarding payments made to distributors, which were conditioned on not charging Eylea customers more for credit card usage [2]. - It is alleged that these payments effectively subsidized the prices for customers using credit cards to purchase Eylea, leading to a misleading boost in reported sales [2]. - The complaint further asserts that Regeneron failed to report these payments as price concessions, resulting in an overstatement of the Average Selling Price (ASP) reported to federal agencies, thus violating the False Claims Act [2]. Group 2: Legal Process and Participation - Investors who suffered losses during the specified timeframe have until March 10, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without incurring any out-of-pocket costs or fees, indicating a no-cost participation model [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the United States [4].