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US Supreme Court to hear 'skinny label' patent fight involving Amarin
Reuters· 2026-01-16 19:44
Core Viewpoint - The U.S. Supreme Court's decision to hear a patent dispute involving Amarin Pharma's cardiovascular drug Vascepa may significantly impact generic drug manufacturers and the "skinny label" strategy [1] Group 1: Patent Dispute - The case centers around Amarin Pharma's Vascepa, which is a cardiovascular drug [1] - The outcome of this dispute could set a precedent affecting the generic drug market [1] Group 2: Implications for Generic Drug Makers - The ruling may influence how generic drug makers approach the development and marketing of their products [1] - The "skinny label" strategy, which allows generics to avoid patent infringement by omitting certain indications, could be affected by the court's decision [1]
亿腾医药拟换股合并嘉和生物
Xin Lang Cai Jing· 2025-12-04 06:18
Core Viewpoint - Edding Group Company Limited is set to reverse merge with Jiahe Biotech-B (06998.HK) through a share swap, marking Hong Kong's first reverse merger of an unprofitable biotech company under the 18A rule [3][5]. Group 1: Company Overview - Edding Group is a comprehensive biopharmaceutical company that has established a competitive portfolio of innovative drugs through acquisitions and licensing agreements with multinational pharmaceutical companies [5]. - The company has successfully launched multiple innovative drugs in China over its 20 years of operation, demonstrating strong clinical development and management capabilities [5]. - Edding's product portfolio includes five main products, three of which are original research products and two are innovative products, all of which have been commercialized [5][6]. Group 2: Financial Performance - Edding's revenue for the years 2022, 2023, 2024, and the first half of 2025 was RMB 2.073 billion, RMB 2.304 billion, RMB 2.546 billion, and RMB 1.136 billion respectively, with corresponding net profits of RMB 306 million, RMB 308 million, RMB 389 million, and RMB 115 million [17][18]. - The gross profit margin for the years 2022 to 2025 remained relatively stable, with gross profits of RMB 1.368 billion (66.0%), RMB 1.506 billion (65.4%), RMB 1.716 billion (67.4%), and RMB 760 million (66.9%) [18]. Group 3: Shareholder Structure - Prior to the merger, the controlling shareholder, Mr. Ni Xin, held 45.19% of the voting rights through various entities [10][11]. - Post-merger, Mr. Ni is expected to become the controlling shareholder of Edding Jiahe, with an estimated holding of approximately 37.39% [10][11]. Group 4: Management Team - The expanded board of directors will consist of seven members, including two executive directors, two non-executive directors, and three independent directors, effective upon completion of the merger [14][15]. - Key executives include Dr. Guo Feng as CEO and Dr. Han Shuhua as Chief Scientific Officer [15].
Genor Biopharma Holdings Limited(H0199) - PHIP (1st submission)
2025-12-02 16:00
The Stock Exchange of Hong Kong Limited and the Securities and Futures Commission take no responsibility for the contents of this Post Hearing Information Pack, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this Post Hearing Information Pack. Post Hearing Information Pack of GENOR BIOPHARMA HOLDINGS LIMITED 嘉和生物藥業 (開 曼 )控股有限公司 (the "Company") (Incorpora ...
嘉和生物药业(开曼)控股有限公司(H0199) - 聆讯后资料集(第一次呈交)
2025-12-02 16:00
香港聯合交易所有限公司及證券及期貨事務監察委員會對本聆訊後資料集的內容概不負責,對其準確性或 完整性亦不發表任何聲明,並表明概不就因本聆訊後資料集全部或任何部分內容而產生或依賴該等內容而 引致的任何損失承擔任何責任。 a a a a a a a a a a a a a a a a GENOR BIOPHARMA HOLDINGS LIMITED 嘉和生物藥業(開曼)控股有限公司 (「本公司」) (於開曼群島註冊成立的有限公司) (股份代號:6998) 的聆訊後資料集 警告 閣下如已將名下之嘉和生物藥業(開曼)控股有限公司股份全部售出或轉讓,應立即將本通函連同隨附之代表委任表格,送交買主或承讓 人或經手買賣或轉讓之銀行、股票經紀或其他代理,以便轉交買主或承讓人。 本通函僅供參考,並不構成收購、購買或認購本公司證券的邀請或要約。 a a a a a a a a a a a a a a a a GENOR BIOPHARMA HOLDINGS LIMITED 嘉和生物藥業(開曼)控股有限公司 本聆訊後資料集乃根據香港聯合交易所有限公司(「聯交所」)及證券及期貨事務監察委員會(「證監會」)的 要求而刊發,僅用作向香港 ...
嘉和生物药业(开曼)控股有限公司(H0199) - 申请版本(第一次呈交)
2025-11-13 16:00
香港聯合交易所有限公司及證券及期貨事務監察委員會對本申請版本的內容概不負責,對其準確性或完整 性亦不發表任何聲明,並表明概不就因本申請版本全部或任何部分內容而產生或依賴該等內容而引致的任 何損失承擔任何責任。 a a a a a a a a a a a a a a a a GENOR BIOPHARMA HOLDINGS LIMITED 嘉和生物藥業(開曼)控股有限公司 (「本公司」) (於開曼群島註冊成立的有限公司) (股份代號:6998) 的申請版本 警告 本申請版本乃根據香港聯合交易所有限公司(「聯交所」)及證券及期貨事務監察委員會(「證監會」)的要求 而刊發,僅用作向香港公眾人士提供資料。 本申請版本為草擬本,其所載資料並不完整,亦可能會作出重大變動。 閣下閱覽本文件,即表示 閣下 知悉、接納並向本公司、其聯席保薦人或顧問表示同意: (a) 本文件僅為向香港公眾人士提供有關本公司的資料,概無任何其他目的。投資者不應根據本文件所 載資料作出投資決定; (b) 在聯交所網站刊發本文件或其任何補充、修訂或更換附頁,並不會引致本公司、其聯席保薦人或顧 問任何須進行本公司反向收購交易(「反向收購交易」)的責任。 ...
Genor Biopharma Holdings Limited(H0199) - Application Proof (1st submission)
2025-11-13 16:00
The publication of this Application Proof is required by The Stock Exchange of Hong Kong Limited (the "Stock Exchange") and the Securities and Futures Commission (the "Commission") solely for the purpose of providing information to the public in Hong Kong. This Application Proof is in draft form. The information contained in it is incomplete and is subject to change which can be material. By viewing this document, you acknowledge, accept and agree with the Company, its joint sponsors or advisers that: GENOR ...
Amarin's Q3 Earnings Lag Estimates, Revenues Beat, Stock Down
ZACKS· 2025-10-30 17:11
Core Insights - Amarin Corporation (AMRN) reported adjusted earnings of 1 cent per share for Q3 2025, missing the Zacks Consensus Estimate of 8 cents per share, compared to an adjusted loss of 5 cents per share in the same quarter last year [1][7] - Total revenues for Q3 were $49.7 million, exceeding the Zacks Consensus Estimate of $43 million, and representing a 17% increase year-over-year due to higher product sales in the U.S. [2][7] Financial Performance - The reported earnings excluded stock-based compensation and restructuring expenses; including these, the company incurred a loss of 2 cents per share in Q3 2025, an improvement from a loss of 6 cents per share in the prior year [2] - Net product revenues from Vascepa, the company's sole marketed drug, were $48.6 million, a 16% year-over-year increase, with U.S. product revenues totaling $40.9 million, surging 34% from the previous year [4][7] - Revenues from the European market for Vazkepa totaled $4.1 million, down 5% year-over-year, attributed to the transition to a fully partnered model with Recordati [5] - Revenues from the rest of the world were $3.6 million, down 48% year-over-year, while licensing and royalty revenues increased by 149% to $1.1 million [8] Cost Management - Selling, general, and administrative expenses decreased by 47% year-over-year to $19.7 million, reflecting the impact of recent restructuring and cost optimization efforts [8] - Research and development expenses totaled $4.2 million, down 7% year-over-year [9] Strategic Developments - Amarin signed a long-term license and supply agreement with Recordati to commercialize Vazkepa across 59 countries in the EU, which is expected to accelerate growth in the European market [10][11] - The company initiated a global restructuring expected to deliver approximately $70 million in cost savings over the next year [10] Market Reaction - Following the earnings announcement, Amarin's shares fell by 11.3% on October 29, although the stock has rallied 73.3% year-to-date compared to the industry's increase of 10.8% [3]
GNTA, BBIO, AMRN Jump After Hours: Key Biotech Catalysts Driving Stock Gains
RTTNews· 2025-10-29 05:03
Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]
Amarin (AMRN) Surges 12.5%: Is This an Indication of Further Gains?
ZACKS· 2025-10-06 14:46
Company Overview - Amarin (AMRN) shares increased by 12.5% to close at $18.84, supported by high trading volume, compared to an 11.4% gain over the past four weeks [1] - The price surge is linked to rising investor confidence in Vascepa, Amarin's sole marketed drug, which treats severe hypertriglyceridemia [1] Earnings Expectations - Amarin is projected to report quarterly earnings of $0.31 per share, reflecting a year-over-year increase of 131% [2] - Expected revenues are $42.36 million, showing a slight increase of 0.2% from the same quarter last year [2] Stock Performance Insights - The consensus EPS estimate for Amarin has remained stable over the last 30 days, indicating that stock price movements may not sustain without earnings estimate revisions [3] - The stock currently holds a Zacks Rank of 2 (Buy), suggesting positive market sentiment [4] Industry Comparison - Amarin operates within the Zacks Medical - Biomedical and Genetics industry, where Fortrea Holdings Inc. (FTRE) has seen a decline of 1.6% to $9.45, with a monthly return of -8.7% [4] - Fortrea's consensus EPS estimate has decreased by 13.3% over the past month to $0.15, representing a 34.8% decline from the previous year [5]
Amarin: Vascepa's Global Pivot From U.S. Squeeze To International Boom
Seeking Alpha· 2025-09-29 21:52
Core Insights - The article emphasizes the importance of strong brand recognition, solid financials, and growth potential in identifying profitable investment opportunities within the consumer products sector [1] Group 1: Investment Focus - The company specializes in the consumer products sector, focusing on identifying firms that combine strong brand recognition with solid financial performance [1] - There is a keen observation of consumer trends, which aids in recognizing potential investment opportunities [1] Group 2: Analytical Approach - The analysis is based on an in-depth understanding of the industry, which enhances the ability to identify profitable investments [1]