Regeneron Pharmaceuticals, Inc. (REGN) obtained positive opinion for its pipeline candidate linvoseltamab from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).The CHMP recommended conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti ...

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]. 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]. - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6]. Group 2: Allegations Against Regeneron - The lawsuit alleges that Regeneron made false and misleading statements regarding its pricing practices for Eylea, including undisclosed payments to distributors that affected the selling price [5]. - Specific claims include that Regeneron’s actions misled investors about the true sales figures and violated the False Claims Act by overstating the Average Sales Price reported to federal agencies [5]. - The lawsuit asserts that when the true details were revealed, investors suffered damages due to the misleading nature of Regeneron's statements about its business and operations [5]. Group 3: Rosen Law Firm's Credentials - The Rosen Law Firm emphasizes its experience and success in securities class actions, having achieved significant settlements and recognition in the field [4]. - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4]. - The firm has been consistently ranked among the top firms for securities class action settlements since 2013 [4].

TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an imm ...

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 ...

FDA decision expected by July 30, 2025TARRYTOWN, N.Y., Feb. 26, 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 odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025. Acceptance of the BLA resubmission follows the ac ...

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]