Hims & Hers Halts Compounded Semaglutide Sales Amid FDA Action
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Should l Buy HIMS?
Source: Newsfilter
- FDA Regulatory Action: The U.S. FDA plans to restrict GLP-1 ingredients used in non-approved compounded drugs due to concerns over quality and safety, leading Hims & Hers to halt its $49 weight-loss pill, which could impact its market competitiveness.
- Market Response: Hims & Hers stated that it had constructive conversations with industry stakeholders since launching the compounded semaglutide pill, deciding to cease offering this treatment, reflecting the company's sensitivity to the regulatory environment.
- Legal Consequences: The FDA has referred Hims & Hers to the Department of Justice, although it did not clarify whether it would quickly halt the sale of the product, this action could significantly affect the company's operations and financial status.
- New Product Launch: Hims & Hers plans to introduce Novo Nordisk's Wegovy pill at an introductory price of $49 per month, about $100 less than the brand name, aiming to attract customers by offering a more competitive alternative.
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Analyst Views on HIMS
Wall Street analysts forecast HIMS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for HIMS is 42.88 USD with a low forecast of 29.00 USD and a high forecast of 85.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
12 Analyst Rating
2 Buy
7 Hold
3 Sell
Hold
Current: 23.480
Low
29.00
Averages
42.88
High
85.00
Current: 23.480
Low
29.00
Averages
42.88
High
85.00
About HIMS
Hims & Hers Health, Inc. provides a consumer-first platform, which helps customers to fulfill their health and wellness needs. Its platform includes access to a provider network, a clinically focused electronic medical record system, digital prescriptions, cloud pharmacy fulfillment, and personalization capabilities. Its digital platform enables access to treatments for a range of chronic conditions, including those related to sexual health, hair loss, dermatology, mental health, and weight loss. It connects patients to licensed healthcare professionals who can prescribe medications when appropriate and prescriptions are fulfilled online through licensed pharmacies on a subscription basis. It also offers access to a range of health and wellness products designed to meet individual needs, which can include curated prescription and non-prescription products. Through its mobile applications, consumers can access a range of educational programs, wellness content, and other services.
About the author

Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
- Launch of Compounded Drug: On February 5, 2026, Hims announced the launch of a compounded semaglutide pill priced starting at $49, aimed at meeting the growing consumer demand for prescription weight loss medications, despite strong opposition and potential legal action from Novo Nordisk.
- FDA Approval vs. Compounded Distinction: Hims clarifies that its compounded products have not undergone FDA evaluation for safety and effectiveness, a critical distinction for consumers when choosing weight loss treatment options, highlighting the regulatory differences between FDA-approved and compounded medications.
- Rise of Telehealth Platforms: As consumer interest in telehealth-based weight loss treatments increases, Hims' service allows users to obtain prescriptions through online consultations, a convenience that may drive more individuals to opt for this treatment method, although not all states offer this service.
- Increased Market Transparency: Hims publicly discloses service details, including the availability of FDA-approved GLP-1 medications and compounded options, aiding consumers in making informed decisions about weight loss plans, reflecting the company's commitment to market transparency.
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- Legal Threats Prompt Withdrawal: Hims & Hers has announced the cessation of its copycat Wegovy weight-loss pill following threats of legal action from Novo Nordisk and the FDA, highlighting the company's vulnerability under regulatory pressure.
- Rapid Market Response: The company had planned to launch the semaglutide-based weight-loss pill at a price of $49 per month, but the legal risks forced a retraction, potentially leading to a decline in customer trust.
- Advertising Plans Affected: Although Hims intended to run an advertisement during the Super Bowl addressing the 'health gap,' the emergence of legal issues may undermine the ad's impact and affect brand perception.
- Industry Backlash: Novo Nordisk accused Hims of 'illegal mass compounding' and noted that the FDA had previously warned them about deceptive advertising, reflecting significant dissatisfaction and caution within the industry regarding Hims' practices.
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- Product Withdrawal: Hims & Hers announced the cessation of its compounded weight-loss pill following legal threats from Novo Nordisk and feedback from industry stakeholders, reflecting the company's commitment to consumer safety.
- Escalating Legal Threats: Novo Nordisk accused Hims of 'illegal mass compounding' and plans to pursue legal and regulatory actions, highlighting the intense competition in the market and the need for intellectual property protection.
- FDA Intervention: The U.S. Food and Drug Administration announced plans to take legal action against Hims, including restricting access to ingredients, which could further negatively impact the company's operations and reputation.
- Advertising Strategy: Despite the controversy, Hims plans to run an advertisement during the Super Bowl, emphasizing the wealth gap as a health gap in America, indicating the company's intent to reshape its brand image through marketing strategies.
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- FDA Regulatory Action: The U.S. FDA plans to restrict GLP-1 ingredients used in non-approved compounded drugs due to concerns over quality and safety, leading Hims & Hers to halt its $49 weight-loss pill, which could impact its market competitiveness.
- Market Response: Hims & Hers stated that it had constructive conversations with industry stakeholders since launching the compounded semaglutide pill, deciding to cease offering this treatment, reflecting the company's sensitivity to the regulatory environment.
- Legal Consequences: The FDA has referred Hims & Hers to the Department of Justice, although it did not clarify whether it would quickly halt the sale of the product, this action could significantly affect the company's operations and financial status.
- New Product Launch: Hims & Hers plans to introduce Novo Nordisk's Wegovy pill at an introductory price of $49 per month, about $100 less than the brand name, aiming to attract customers by offering a more competitive alternative.
See More
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