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Health Regulators Ask DOJ to Investigate Hims & Hers. The Stock Plunges.
Barrons· 2026-02-07 01:25
Health Regulators Ask DOJ to Investigate Hims & Hers. The Stock Plunges. - Barron'sSkip to Main ContentThis copy is for your personal, non-commercial use only. Distribution and use of this material are governed by our Subscriber Agreement and by copyright law. For non-personal use or to order multiple copies, please contact Dow Jones Reprints at 1-800-843-0008 or visit www.djreprints.com.# Health Regulators Ask DOJ to Investigate Hims & Hers. The Stock Plunges.By [Evie Liu]ShareResize---ReprintsIn this arti ...
Hims & Hers Health(HIMS.US)推出廉价减肥药次日即遭FDA叫停,股价盘后暴跌
Xin Lang Cai Jing· 2026-02-07 01:17
来源:智通财经网 美国食品药品监督管理局(FDA)表示,将打击类似Hims & Hers Health(HIMS.US)所销售的仿制减肥药。 就在此前一天,这家远程医疗公司开始提供一种价格大幅打折的仿制药品。 远程医疗公司通过调整剂量或添加成分来规避规则,使他们的产品被认为与品牌版本有所区别。 在一项更明确的行动中,美国卫生与公众服务部(HHS)总法律顾问迈克·斯图尔特周五在 X 上发帖称, 该机构已根据《联邦食品、药品和化妆品法案》中的犯罪及刑事诉讼条款,将 Hims 移交给司法部进行 调查。 诺和诺德发言人利兹·斯克尔布科娃在声明中表示:"我们欢迎 HHS 和 FDA 今天采取的行动,以保护患 者免受未经批准的仿制药侵害,这些药物是由外国不真实的活性药物成分制成的,可能对患者安全构成 重大风险。" Hims 的代表表示,公司一直按照适用法律运营,并"期待继续与 FDA 接触,以确保人们能够安全地获 得负担得起的医疗服务"。 礼来在声明中对这一举措表示赞赏,称公司期待 FDA、其他监管机构和执法部门采取行动。 诺和诺德与 Hims 之间有一段波折的历史。去年,两家公司曾合作提供诺和诺德注射减肥药的折扣版 本 ...
盘后暴跌超14%!FDA监管震动Hims & Hers股价
美股IPO· 2026-02-07 00:35
Core Viewpoint - Hims & Hers Health Inc's stock plummeted 12.6% after the FDA issued a warning regarding the sale of unapproved compounded GLP-1 drugs, indicating a significant regulatory challenge for the company [1]. Regulatory Actions - The FDA is taking decisive actions against companies like Hims & Hers that sell compounded drugs as alternatives to approved treatments, aiming to protect consumers from unverified products [3]. - The FDA's intervention follows Hims & Hers' aggressive expansion, including the launch of a compounded semaglutide tablet priced at $49 per month, which the company claims is designed to enhance absorption [3]. - The FDA has warned that companies cannot claim unapproved compounded products are equivalent to FDA-approved drugs, indicating a tightening of regulations [3]. Competitive Landscape - Novo Nordisk, the manufacturer of the popular drug Wegovy, has responded by labeling Hims & Hers' new product as "unapproved, misleading, and untested," and plans to take legal and regulatory action against the company for "illegal mass compounding" [3]. - Novo Nordisk emphasizes that it remains the only manufacturer producing a legally approved oral semaglutide tablet using proprietary absorption technology [3]. Company Positioning - Hims & Hers executives argue that their platform provides essential accessibility and personalized services for patients who prefer non-injection methods [4]. - The company claims to have invested years in building the necessary infrastructure to offer personalized options to patients [4]. - The FDA's recent stance indicates an escalation in actions against misleading direct-to-consumer advertising, following previous warnings about unverified claims regarding compounded drugs [4]. Market Implications - The regulatory crackdown creates a volatile environment for telehealth investors, as Hims & Hers faces significant survival threats since its inception [5]. - The market is closely monitoring whether the FDA will follow through on its threats of legal action without prior notice, which could impact Hims & Hers' promised affordability [5].
FDA Targets Hims & Hers, Other Marketers of Unapproved GLP-1 Weight-Loss Drugs
WSJ· 2026-02-06 23:23
Core Viewpoint - The FDA is taking decisive steps to restrict the use of GLP-1 active pharmaceutical ingredients in non-approved drugs [1] Group 1 - The FDA's actions indicate a regulatory tightening around GLP-1 drugs, which may impact companies involved in the development and marketing of these pharmaceuticals [1]
US signals crackdown on compounded weight-loss drugs; Hims shares tumble
Reuters· 2026-02-06 21:59
The U.S. Food and Drug Administration said on Friday it plans to restrict GLP-1 ingredients used in non-approved compounded drugs that companies such as Hims & Hers and other compounding pharmacies ha... ...
Hims & Hers stock nears one-year low amid battle over compounded Wegovy pill
MarketWatch· 2026-02-06 20:29
Hims & Hers also said it's selling a cancer-detection test that's featured in its Super Bowl ad, which plays like a commentary on the wealthy's access to better healthcare. ...
Hims' $49 weight-loss pill rattles investor case for cash-pay obesity market
Reuters· 2026-02-06 18:14
Core Viewpoint - Hims & Hers is attempting to sell a $49 compounded version of Novo Nordisk's Wegovy pill, which is causing turbulence in the obesity drug market and raising questions about the legality of this strategy, potentially impacting the returns of established drugmakers in the sector [1] Group 1 - Hims & Hers' new product is significantly cheaper than the original Wegovy, which may attract consumers looking for more affordable obesity treatment options [1] - The move has sparked a debate regarding the legality of selling compounded medications, which could lead to regulatory scrutiny and affect market dynamics [1] - The introduction of this compounded version threatens the profitability of major pharmaceutical companies that produce obesity drugs, as it may lead to a decrease in their market share [1]
Hims & Hers Strengthens Platform-Led Digital Healthcare Model
ZACKS· 2026-02-06 16:31
Key Takeaways Hims & Hers runs a proprietary digital platform linking providers, personalized plans and ongoing care.HIMS launched Labs for biomarker tracking, feeding provider action plans and deeper personalization.Hims & Hers acquired YourBio Health and invested in AI to integrate diagnostics with digital care delivery.The renowned health and wellness platform, Hims & Hers Health, Inc. (HIMS) , operates as a digital healthcare platform built on proprietary technology that integrates care delivery, data a ...
受诺和诺德法律威胁,Hims & Hers早盘大跌6.5%
Xin Lang Cai Jing· 2026-02-06 15:44
这一价格远低于诺和诺德在其直连消费者的官网诺和关怀上的定价 —— 该平台上,维格卫起始剂量的 售价为 149 美元。 来源:环球市场播报 作者:埃尔莎・奥伦 这张图片为示意图,智能手机屏幕上显示着 Hims & Hers 健康公司的品牌标识。 受诺和诺德发出法律威胁影响,远程医疗企业 Hims & Hers 的股价在本周五早盘交易中走低。 这家线上远程医疗公司于周四宣布,计划推出诺和诺德减肥药丸的平价仿制品,此举直接引发诺和诺德 采取法律行动。 消息传出后,Hims 的股价在周四的交易中一度飙升 15%,但在诺和诺德指认该行为 "涉嫌违法" 后,股 价迅速回吐涨幅,最终收跌 3.8%,创 12 个月新低;本周五早盘交易中,其股价再度下跌 6.5%。 Hims 方面表示,将推出一款维格卫同款减肥药丸,其有效成分与原研药一致,均为司美格鲁肽。用户 订阅后,首月用药价格低至 49 美元,首月过后,价格将上调至 99 美元。 与此同时,巴克莱银行分析师詹姆斯・戈登认为,这款定价 49 美元的维格卫仿制品,成为诺和诺德面 临的 "新隐患"。 他补充道:"尽管这类复合仿制药短期内可能吸引对价格敏感的患者,但该类产品的监管 ...
NVO, LLY Stocks Slide as HIMS Launches $49 Compounded Semaglutide Pill
ZACKS· 2026-02-06 15:30
Key Takeaways Hims & Hers launched a compounded oral semaglutide weight-loss pill as a needle-free option for patients.Novo Nordisk shares slid after HIMS priced its pill at $49, challenging high-priced branded GLP-1 injectables.HIMS stock reversed gains after FDA warned against mass-marketing illegal copycat drugs. Hims & Hers Health, Inc. (HIMS) , a leading health and wellness platform, is moving further into the fast-growing weight-loss market with the announcement of a new compounded semaglutide pill th ...