Accessibility StatementSkip Navigation NEW YORK, Sept. 9, 2025 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Organon & Co. (NYSE: OGN) breached their fiduciary duties to shareholders. For additional information, please visit Shareholder Derivative Litigation - Kuehn Law. Attorney advertising. Prior results do not guarantee similar outcomes. Contacts:Kuehn Law, PLLCJustin Kuehn, Esq.53 Hill Street, Suite 605Southampton, NY 119 ...

VANCOUVER, BC / ACCESS Newswire / September 8, 2025 / (TSXV:OGN)(OTCQB:OGNNF) Orogen Royalties Inc. ("Orogen" or the "Company") is pleased to announce its shares have been qualified to begin trading on the OTCQB® Venture Market ("OTCQB"). Orogen Royalties Inc. begins trading today on OTCQB under the symbol "OGNNF". ...

Core Viewpoint - Fuhong Hanlin's stock rose nearly 6% following the FDA approval of two biosimilar products, BILDYOS and BILPREVDA, in collaboration with Organon, enhancing its market position in the U.S. biosimilar sector [1] Group 1: Company Developments - Fuhong Hanlin's stock price increased by 5.78%, reaching 81.45 HKD, with a trading volume of 48.73 million HKD [1] - The FDA approved BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), which are biosimilars to PROLIA and XGEVA, respectively [1] - The approval covers all indications for the original products in the U.S. market [1] Group 2: Partnership and Market Impact - In 2022, Fuhong Hanlin entered into a licensing and supply agreement with Organon, granting Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [1] - The approval of these products strengthens Organon's biosimilar portfolio in the U.S., which has been developed over eight years and spans five major therapeutic areas [1]

BILDYOS® (60mg/ml) 骨质疏松症等5项适应症 BILPREVDA® (120mg/1.7ml) 骨相关事件等3项适应症 0 自个海外获批"中国籍"地舒单抗 ■ 复宏汉霖已有3款产品在美国获批 格隆汇9月2日｜复宏汉霖(2696.HK)与Organon(OGN.US)9月2日共同宣布，美国食品药品监督管理局 (FDA)已批准地舒单抗注射液(60mg/mL)BILDYOS®(denosumab-nxxp)和地舒单抗注射液 (120mg/1.7mL)BILPREVDA®(denosumab-nxxp)的上市申请。两款产品分别为PROLIA®(denosumab)和 XGEVA®(denosumab)的生物类似药，此次获批覆盖原研产品在美国已获批的所有适应症。 复宏汉霖执行董事兼CEO朱俊博士表示："BILDYOS 和 BILPREVDA 获得美国FDA批准，标志着复宏 汉霖又一批自主研发、自主生产的生物类似药取得美国监管认可，也体现了我们对科学卓越和产品质量 的承诺。我们很荣幸能够通过与Organon 的合作，继续扩大优质生物药的可及性，为更多美国患者提供 在疗效和安全性上与原研药同等的生物类似药治 ...

复宏汉霖执行董事兼首席执行官朱俊博士表示："BILDYOS 和 BILPREVDA 获得美国 FDA 批准，标志 着复宏汉霖又一批自主研发、自主生产的生物类似药取得美国监管认可，也体现了我们对科学卓越和产 品质量的承诺。"通过与 Organon 的合作，复宏汉霖将继续扩大优质生物药的可及性，为更多美国患者 提供在疗效和安全性上与原研药同等的生物类似药治疗选择。 智通财经了解到，BILDYOS 和 BILPREVDA 的获批是基于一整套全面数据的审查，其中包括结构与功 能分析数据、临床药代动力学数据，以及一项临床对比研究。研究表明，BILDYOS 和BILPREVDA 在 安全性、纯度和效力方面与原研药 PROLIA 和 XGEVA 高度相似，且无临床意义上的差异。 据悉，2022年，复宏汉霖与 Organon 签订许可与供应协议，授予 Organon 对包括BILDYOS 和 BILPREVDA 在内的多个生物类似药在除中国以外的全球区域的独家商业化权益。BILDYOS和 BILPREVDA的获批，进一步充实了 Organon 在美国的生物类似药产品组合。该组合已深耕逾八年，覆 盖五大主要治疗领域。 智通财经 ...

智通财经了解到，BILDYOS和BILPREVDA的获批是基于一整套全面数据的审查，其中包括结构与功能 分析数据、临床药代动力学数据，以及一项临床对比研究。研究表明，BILDYOS和BILPREVDA在安全 性、纯度和效力方面与原研药PROLIA和XGEVA高度相似，且无临床意义上的差异。 据悉，2022年，复宏汉霖与Organon签订许可与供应协议，授予Organon对包括BILDYOS和BILPREVDA 在内的多个生物类似药在除中国以外的全球区域的独家商业化权益。BILDYOS和BILPREVDA的获批， 进一步充实了Organon在美国的生物类似药产品组合。该组合已深耕逾八年，覆盖五大主要治疗领域。 Organon生物类似药和普药业务美国商业主管Jon Martin表示："BILDYOS和BILPREVDA的FDA成功获 批标志着我们朝提升关键骨骼护理治疗可及性迈出了重要一步。数百万美国人，都需要这些治疗，尤其 是日益增长的老龄化人口。我们开发这些生物类似药的目标是提高多个治疗领域的可及性和可负担性， 包括对女性影响很大的骨质疏松症。" 复宏汉霖执行董事兼首席执行官朱俊博士表示："BILDYOS和BI ...

复宏汉霖执行董事兼首席执行官朱俊博士表示："BILDYOS 和 BILPREVDA 获得美国 FDA 批准，标志 着复宏汉霖又一批自主研发、自主生产的生物类似药取得美国监管认可，也体现了我们对科学卓越和产 品质量的承诺。"通过与 Organon 的合作，复宏汉霖将继续扩大优质生物药的可及性，为更多美国患者 提供在疗效和安全性上与原研药同等的生物类似药治疗选择。 智通财经了解到，BILDYOS 和 BILPREVDA 的获批是基于一整套全面数据的审查，其中包括结构与功 能分析数据、临床药代动力学数据，以及一项临床对比研究。研究表明，BILDYOS 和BILPREVDA 在 安全性、纯度和效力方面与原研药 PROLIA 和 XGEVA 高度相似，且无临床意义上的差异。 据悉，2022年，复宏汉霖与 Organon 签订许可与供应协议，授予 Organon 对包括BILDYOS 和 BILPREVDA 在内的多个生物类似药在除中国以外的全球区域的独家商业化权益。BILDYOS和 BILPREVDA的获批，进一步充实了 Organon 在美国的生物类似药产品组合。该组合已深耕逾八年，覆 盖五大主要治疗领域。 智通财经 ...

Group 1 - A lawsuit has been filed against Organon & Co. by an investor over alleged violations of securities laws, claiming that the company provided misleading statements while concealing material adverse facts [2] - The lawsuit specifically addresses the company's capital allocation priorities, particularly regarding a significant reduction in quarterly dividends by 70% following the acquisition of Dermavant [2] - Investors who purchased shares of Organon & Co. prior to October 2024 are encouraged to contact the Shareholders Foundation for potential options [1][3] Group 2 - The Shareholders Foundation, Inc. is involved in monitoring legal issues related to shareholders and provides information on securities class actions and settlements [3] - The foundation is not a law firm and does not initiate legal actions, but serves as a public service to inform investors [3]

Group 1 - Organon & Co.'s securities are currently undervalued, with a forward P/E ratio of approximately 2.4x compared to the sector average of 17x [1] - Following the separation from Merck, Organon's stock price has fallen below $10 [1] Group 2 - The article emphasizes that a low price does not necessarily indicate a good investment opportunity [1]

Core Insights - Organon (OGN) is currently more attractive to value investors compared to HealthEquity (HQY) based on various financial metrics and Zacks Rank [3][7]. Valuation Metrics - OGN has a forward P/E ratio of 2.38, significantly lower than HQY's forward P/E of 24.60 [5]. - The PEG ratio for OGN is 0.90, while HQY's PEG ratio stands at 1.18, indicating OGN's better valuation relative to its expected earnings growth [5]. - OGN's P/B ratio is 3.23, compared to HQY's P/B ratio of 3.74, further supporting OGN's more favorable valuation [6]. Zacks Rank and Style Scores - OGN holds a Zacks Rank of 2 (Buy), indicating a stronger earnings outlook, while HQY has a Zacks Rank of 3 (Hold) [3]. - OGN has a Value grade of A, whereas HQY has a Value grade of C, reflecting OGN's superior valuation metrics [6].