ToplineThe Food and Drug Administration sent warning letters to dozens of drug companies this month, including popular telehealth firm Hims & Hers, demanding they correct “false or misleading claims” about some of their products, targeting the companies just days after President Donald Trump signed an order designed to clamp down on direct-to-consumer drug advertising.Hims was one of dozens of companies that received the warning letters. (Photo illustration by Cheng Xin/Getty Images)Getty Images ...

Hims & Hers Health Inc. (NYSE: HIMS) saw its stock fall 6% on Tuesday following the release of a warning letter from the US Food and Drug Administration (FDA) concerning marketing claims related to it... ...

Hims & Hers Health Inc. HIMS stock is trading lower on Tuesday. The U.S. Food and Drug Administration (FDA) issued a warning letter to Hims & Hers Health, dated Sept. 9, addressed to the company’s CEO, Andrew Dudum.HIMS is encountering selling pressure. See the trading setup here.The FDA flagged misleading claims made by Hims & Hers Health regarding its compounded semaglutide products. Semaglutide is an active ingredient in Novo Nordisk A/S’ NVO flagship Wegovy and Ozempic.In a warning letter, the FDA said ...

We came across a bullish thesis on Hims & Hers Health, Inc. on PatchTogether Investing’s Substack. In this article, we will summarize the bulls’ thesis on HIMS. Hims & Hers Health, Inc.'s share was trading at $48.11 as of September 4th. HIMS’s trailing and forward P/E were 60.90 and 62.50 respectively according to Yahoo Finance. Hims & Hers (NYSE: HIMS) saw its stock fall 30% after Q2 2025 earnings as investors questioned whether its growth story is losing steam. Revenue fell sequentially for the first t ...

The U.S. Food and Drug Administration has sent a warning letter to telehealth firm Hims & Hers Health regarding its compounded versions of Novo Nordisk's diabetes drug Ozempic and weight-loss treatment Wegovy. ...

文章核心观点 - 美国食品药品监督管理局向远程医疗巨头Hims & Hers Health发出警告信 指责其销售复合版司美格鲁肽产品的营销宣传存在误导性 导致公司股价单日下跌超过7% [1][2] FDA警告信内容 - FDA指出公司在网站上销售复合药物司美格鲁肽 并声称其产品使用与诺和诺德品牌药Ozempic和Wegovy"相同的活性成分" [1][2] - FDA认为这些宣传语暗示其产品与FDA批准的药物相同 但实际上复合药物并未经FDA批准 因此属于虚假或误导性宣传 产品被认定为冒牌货 [2] - FDA要求公司在15天内对指控作出回应 或提供证据证明其产品未违反法律 [5] 公司业务与产品背景 - Hims & Hers Health是一家远程医疗巨头 业务包括复合药物 公司销售护肤 性健康和防脱发产品 [3] - 公司于2024年5月推出复合司美格鲁肽后知名度大增 当时品牌药司美格鲁肽正处于短缺状态 复合药物制造商得以填补供应缺口 [3][4] - FDA于今年2月确定短缺结束 但公司目前利用漏洞继续销售个性化剂量的司美格鲁肽 [4] 市场反应与股价表现 - 受FDA警告信影响 公司股价在盘中交易中下跌超过7%至49.91美元 股价下探至50日移动平均线支撑位 [2] - 公司股价今年波动剧烈 2月曾创下近73美元的历史高点 4月回落至24美元附近 7月反弹至70美元以上 近期又跌至41美元附近 [6] - 截至周一收盘 公司股价较9月2日的低点已反弹32% [6]

Key Takeaways HIMS appoints Mo Elshenawy as CTO to accelerate its AI-powered digital health platform strategy.Hims & Hers' recent $870 million convertible notes raise will fund AI, diagnostics and global tech expansion.HIMS leverages proprietary algorithms and cloud systems to scale personalized virtual care delivery.The renowned health and wellness platform, Hims & Hers Health, Inc. (HIMS) , is actively deepening its technology integration to transform how healthcare is delivered. The company recently appo ...

FDA强调，复合型药物产品本身并未获得FDA批准，因此不得将其等同于经过临床试验和审批的标准药 品。监管机构已要求Hims&Hers在15个工作日内提交整改措施，若未能有效应对相关问题，可能将面临 包括扣押产品、发布禁令在内的法律制裁。 周二，Hims&Hers Health(HIMS.US)股价走低，截至发稿，该股跌超7%，报49.99美元。此前该公司因 其关于"复合型司美格鲁肽"产品的宣传内容收到美国食品药品监督管理局(FDA)的正式警告信。 ...

FDA强调，复合型药物产品本身并未获得FDA批准，因此不得将其等同于经过临床试验和审批的标准药 品。监管机构已要求Hims & Hers在15个工作日内提交整改措施，若未能有效应对相关问题，可能将面 临包括扣押产品、发布禁令在内的法律制裁。 智通财经APP获悉，周二，Hims & Hers Health(HIMS.US)股价走低，截至发稿，该股跌超7%，报49.99 美元。此前该公司因其关于"复合型司美格鲁肽"产品的宣传内容收到美国食品药品监督管理局(FDA)的 正式警告信。 ...

In the latest trading session, Hims & Hers Health, Inc. (HIMS) closed at $54.03, marking a -2.65% move from the previous day. The stock's change was less than the S&P 500's daily gain of 0.47%. Meanwhile, the Dow experienced a rise of 0.11%, and the technology-dominated Nasdaq saw an increase of 0.94%. The stock of company has risen by 20.6% in the past month, leading the Medical sector's gain of 5.49% and the S&P 500's gain of 2.32%.Market participants will be closely following the financial results of Him ...