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].

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].