All articles tagged with #hims and hers
Novo Nordisk has filed a US lawsuit to block Hims & Hers from selling weight‑loss pills and injections it says are unapproved and infringe its patents, arguing safety concerns over compounded versions. The move comes as the FDA tightens rules on compounding, and amid broader pressure from expiring patents on Wegovy/Ozempic; Hims & Hers’ stock fell while Novo Nordisk edged higher following the filing.
Novo Nordisk filed a lawsuit seeking a permanent ban and damages against Hims & Hers for allegedly selling compounded, patent-infringing versions of Wegovy (semaglutide); Hims paused its obesity-pill copycat after regulatory scrutiny as FDA actions loom, underscoring a broader crackdown on compounded GLP-1 drugs used by as many as 1.5 million Americans amid intense obesity-drug competition.
Hims & Hers has canceled its plan to develop a Wegovy‑style weight‑loss medication, shelving a project to mimic Novo Nordisk’s semaglutide as the company reassesses its drug‑development strategy in the competitive obesity market.
Hims & Hers will stop selling a cheaper, compounded version of Novo Nordisk’s obesity pill Wegovy after health officials called for an investigation into possible federal-law violations; the platform had offered a $49/month compounded version, while Novo Nordisk’s Wegovy costs $149–$299/month, as FDA and HHS/DOJ actions move to curb unapproved compounded GLP-1 drugs.
Novo Nordisk said it will take legal and regulatory action against telehealth provider Hims & Hers after it unveiled a cheaper copycat Wegovy. Hims plans an oral semaglutide pill priced at $49 for the first month and $99 thereafter under a 5-month plan, triggering about 7% declines in Novo Nordisk and Eli Lilly shares; Novo argues the product is illegal mass compounding that risks patient safety, while Hims says its copy uses a different formulation. Wegovy’s SNAC absorption technology is a key point of contrast, and Lilly is preparing its own oral GLP-1, orforglipron, pending FDA approval.
Novo Nordisk says Hims & Hers’ new $49/month, compounded semaglutide version of Wegovy is illegal mass compounding and unsafe, pledging legal action; the FDA has warned against copycat GLP‑1 drugs. The move intensifies price competition in obesity drugs, with Novo forecasting up to a 13% drop in net sales and shares for Novo Nordisk and Lilly slipping.
The FDA has begun cracking down on telehealth companies like Hims & Hers for promoting unapproved and misleading versions of prescription drugs, including weight loss medications, as part of a broader effort to ensure truthful pharmaceutical advertising. The agency sent over 100 cease and desist letters to companies making false claims, highlighting concerns over online drug promotion and advertising practices that may mislead consumers about drug safety and efficacy.
FDA Commissioner Martin Makary criticized Hims & Hers' Super Bowl ad for violating federal law by promoting weight-loss drugs without discussing potential side effects, highlighting concerns over misleading direct-to-consumer pharmaceutical advertising and a decline in FDA enforcement actions.
Hims & Hers Health stock declined while GoodRx shares rose following a deal with Novo Nordisk, reflecting differing market reactions to recent corporate developments.
Hims & Hers, a telehealth company known for weight-loss drugs, experienced a volatile quarter with a significant stock decline due to sales disappointments and market uncertainties, especially in its weight-loss and sexual health segments, raising questions about its long-term growth prospects.
Stock futures rose as markets gained optimism for a September rate cut. Palantir surged 5.3% after strong Q2 earnings and raised full-year guidance, while Vertex fell 16% due to a failed drug trial. Hims & Hers dropped 13% amid lower-than-expected profits, and other companies like DuPont and Axon reported mixed results. BP and AMD showed positive movements, with BP exceeding profit expectations and AMD preparing to report earnings. Several other companies are set to release earnings today.
Hims & Hers stock dropped over 11% after missing Wall Street's Q2 sales forecast despite higher profits, as the company shifts focus to personalized healthcare and faces challenges in its obesity-related business. The company maintains its annual sales guidance but faces scrutiny over its core business and recent market performance, amid a broader industry context involving weight-loss drugs and strategic partnerships.
Hims & Hers stock dropped 10% after missing revenue expectations in Q2, despite a 73% revenue increase year-over-year and higher net income. The company forecasted Q3 revenue slightly below analyst estimates and reported strong EBITDA, but faced controversy over compounded drug sales and a failed collaboration with Novo Nordisk.
Hims & Hers will offer generic semaglutide in Canada after Novo Nordisk's patent on Ozempic and Wegovy expired in January 2023 due to non-payment of maintenance fees, opening the market for more affordable weight loss treatments. The Canadian market for semaglutide is rapidly growing, and Hims aims to provide accessible, high-quality care, although the approval process for generics is still underway. Novo Nordisk's patent lapse was due to administrative oversight, and the company has stated that patent expirations are part of the normal lifecycle of pharmaceutical products.
Hims & Hers experienced a setback after its partnership with Novo Nordisk ended abruptly due to disputes over marketing and the sale of compounded versions of Wegovy, a popular weight-loss drug. The split highlights tensions between telehealth platforms and pharmaceutical companies, with Hims & Hers continuing to expand its offerings despite legal and regulatory challenges. The company, which has grown rapidly and aims for significant revenue by 2030, faces potential revenue loss from the termination of its partnership but remains focused on broadening its healthcare services.