Regeneron(REGN)
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智慧芽生物医药:小核酸设计、专利布局与检索方案
Zhi Hui Ya· 2025-03-06 02:53
Investment Rating - The report does not explicitly state an investment rating for the small nucleic acid industry. Core Insights - The small nucleic acid field is experiencing significant advancements in patent strategies, particularly in the areas of chemical modifications and delivery technologies. Companies like Alnylam are leading the way in establishing a strong patent barrier through innovative approaches to RNA modifications and targeted delivery systems [4][24][25]. Summary by Sections Current Patent Landscape - The report outlines the current patent landscape in the small nucleic acid sector, highlighting key patents related to siRNA mechanisms and structural features. Early patents primarily cover siRNA mechanisms and typical structural characteristics, with companies like Alnylam acquiring exclusive licenses to build their patent barriers [8][9]. Challenges in Chemical Modification Searches - The report identifies challenges in searching for chemical modifications, including the diversity of modification descriptions and the lack of commercial databases supporting searches by chemical type. It emphasizes the need for standardized modification descriptions to facilitate better patent searches [22][27][32]. Breakthroughs in Domestic Small Nucleic Acid Design - The report discusses breakthroughs in domestic small nucleic acid design, focusing on the development of siRNA targeting validated genes. It emphasizes the importance of establishing "target patents" to protect against early entrants in the market [11][39]. Case Study: HSD17B13 - A case study on HSD17B13 highlights the active research and patenting efforts by companies like Regeneron and Alnylam in developing RNAi therapies targeting this gene. The report details the specific sequences and modifications involved in these patents [37][39][54]. Patent Search Workflow - The report outlines a comprehensive workflow for patent searches in the small nucleic acid field, including target name searches, sequence searches, and modification searches. This structured approach aims to streamline the identification of relevant patents and potential infringement risks [36][45][51].
Inclusion Body Myositis Pipeline Market Landscape Report 2025 Featuring Abcuro, Regeneron Pharmaceuticals, and Vandria
GlobeNewswire News Room· 2025-03-05 15:39
Core Insights - The report titled "Inclusion Body Myositis - Pipeline Insight, 2025" provides a comprehensive overview of the current pipeline for Inclusion Body Myositis (IBM), highlighting the efforts of over 2 companies and the development of more than 3 pipeline drugs projected until 2025 [2][4]. Group 1: Understanding Inclusion Body Myositis - Inclusion Body Myositis is a progressive muscle disorder primarily affecting adults over 50, with an estimated patient population exceeding 50,000 in the U.S. and Europe [3]. - The report addresses both symptomatic and pathophysiological aspects of IBM, along with insights into diagnostic methodologies and current treatment paradigms [3]. Group 2: Current Treatment Landscape - There are currently no approved therapeutic options specifically for IBM, and existing treatments like immunosuppressants and corticosteroids have shown limited efficacy [4]. - The report discusses various strategies under investigation to meet the unmet medical needs in this therapeutic area [4]. Group 3: Advancements in the Therapeutic Pipeline - The report highlights emerging drugs in the IBM pipeline, including ABC008 by Abcuro, Inc., which is an anti-KLRG1 antibody currently in Phase II/III trials targeting cytotoxic T cells involved in IBM [5]. Group 4: Strategic Developments and Future Outlook - The report details pipeline development activities such as collaborations, acquisitions, mergers, and licensing that are shaping the future of IBM treatments [6]. - These strategic developments may provide new pathways for improving care and management for individuals affected by IBM [6].
CLASS ACTION DEADLINE APPROACHING: Berger Montague Advises Regeneron Pharmaceuticals (NASDAQ: REGN) Investors to Inquire About a Securities Fraud Class Action by March 10, 2025
Prnewswire· 2025-03-05 13:33
PHILADELPHIA, March 5, 2025 /PRNewswire/ -- Berger Montague PC advises investors that a securities class action lawsuit has been filed against Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company") (NASDAQ: REGN) on behalf of purchasers of Regeneron securities between November 2, 2023 through October 30, 2024, inclusive (the "Class Period").Investor Deadline: Investors who purchased or acquired REGENERON securities during the Class Period may, no later than MARCH 10, 2025, seek to be appointed as a ...
Regeneron Pharmaceuticals, Inc. (REGN) TD Cowen 45th Annual Health Care Conference (Transcript)
Seeking Alpha· 2025-03-04 19:11
Group 1 - Regeneron Pharmaceuticals participated in the TD Cowen 45th Annual Health Care Conference, highlighting its ongoing engagement with investors and analysts [1] - Marion McCourt, Chief Commercial Officer, and Ryan Crowe, Senior Vice President of Investor Relations, represented the company during the conference [1] - The conference included a forward-looking statement disclaimer, indicating that remarks may involve risks and uncertainties that could affect actual results [3] Group 2 - The discussion began with a focus on the EYLEA franchise, with inquiries about its latest developments and key catalysts for growth in 2025 [4]
Contact Levi & Korsinsky by March 10, 2025 Deadline to Join Class Action Against Regeneron Pharmaceuticals, Inc.(REGN)
Prnewswire· 2025-03-04 10:45
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 and concealed payments made to distributors to cover credit card fees, which misled investors about the pricing and sales of Eylea [2]. - It is alleged that these payments allowed Regeneron to offer price concessions that lowered Eylea's selling price, misleadingly boosting reported sales figures [2]. - The complaint also states 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: Investor Actions - 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 serving as a lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees, indicating a no-cost participation model [3]. Group 3: Legal Representation - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years and consistently ranking among the top securities litigation firms in the U.S. [4].
Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug
ZACKS· 2025-03-03 21:00
Core Opinion - Regeneron Pharmaceuticals, Inc. has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its pipeline candidate linvoseltamab, aimed at treating adults with relapsed and refractory multiple myeloma [1][2] Pipeline Candidate - Linvoseltamab is a bispecific antibody designed to activate T-cells against multiple myeloma cells by targeting B-cell maturation antigen [5] - The recommendation for conditional marketing authorization is for patients who have undergone at least three prior therapies and have shown disease progression [2] Regulatory Developments - The FDA has accepted the biologics license application for linvoseltamab, with a target action date set for July 10, 2025 [6] - The acceptance follows the resolution of manufacturing issues identified in a previous complete response letter [7] Clinical Trials - Linvoseltamab is undergoing a broad clinical development program, including a phase Ib study and a phase III confirmatory study [8][7] Oncology Portfolio Expansion - Regeneron is actively working to strengthen its oncology portfolio, which includes Libtayo and the recently approved odronextamab for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma [9][10] - The FDA has also accepted the resubmission of the BLA for odronextamab, with a target action date of July 30, 2025 [11] Financial Performance - Regeneron’s shares have declined by 30.5% over the past year, contrasting with a 6.7% decline in the medical-biomedical genetics industry [3] - The company reported better-than-expected results for the fourth quarter, but faces challenges due to declining sales of its lead drug, Eylea, which is under pressure from competition [13]
REGN Deadline: REGN Investors with Losses in Excess of $100K Have Opportunity to Lead Regeneron Pharmaceuticals, Inc. Securities Fraud Lawsuit
Prnewswire· 2025-03-02 17:52
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].
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
Globenewswire· 2025-02-28 12:00
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]
Levi & Korsinsky Reminds Regeneron Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of March 10, 2025 - REGN
Prnewswire· 2025-02-28 10:45
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 ...
SHAREHOLDER REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Regeneron Pharmaceuticals
Prnewswire· 2025-02-27 15:06
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Regeneron Pharmaceuticals, Inc. related to alleged violations of federal securities laws, particularly concerning misleading statements and undisclosed financial practices that may have inflated the reported sales of its drug Eylea [2][4][5]. 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, leading to inflated sales figures for Eylea [4]. - It is claimed that Regeneron's actions provided a competitive advantage by subsidizing treatment costs, which misled investors about the company's true financial health [5]. - The U.S. Department of Justice filed a complaint against Regeneron under the False Claims Act, alleging that the company failed to report millions in discounts, resulting in inflated Average Selling Prices (ASP) for Eylea [5]. Group 2: Financial Impact and Stock Performance - 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 third-quarter 2024 financial results, revealing only a 3% increase in U.S. net sales for Eylea compared to the previous year, with sales of Eylea HD at $392 million, missing consensus estimates [7]. - The stock price dropped by $84.59, or 9.2%, to close at $838.20 per share on the same day, indicating a significant market reaction to the disappointing sales figures [7]. Group 3: Legal Proceedings and Investor Actions - 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 firm is also seeking information from whistleblowers, former employees, and shareholders regarding Regeneron's conduct [9].