Hims & Hers Health: Navigating Legal Quicksand and the Path to Shareholder Redemption

The abrupt termination of Hims & Hers Health's (HIMS) partnership with Novo Nordisk in June 2025, coupled with a subsequent 34.6% stock plunge, has thrust the company into a crisis of regulatory, operational, and reputational collapse. At the heart of this turmoil lies a web of alleged misstatements, violations of FDA regulations, and governance failures that have left shareholders exposed to material losses. For investors, the path forward hinges on understanding the legal and operational risks now crystallizing—and acting swiftly to secure rights through litigation-driven value recovery.

The Partnership Collapse: A Foreseeable Disaster

The collaboration with Novo Nordisk, which granted Hims access to Wegovy (semaglutide) for its telehealth platform, was terminated after Novo accused Hims of selling illegitimate knockoff versions of the drug. These counterfeit products allegedly contained unapproved active pharmaceutical ingredients (APIs) sourced from Chinese manufacturers, violating FDA safety protocols. Novo's termination letter, dated June 2025, explicitly cited Hims' noncompliance with FDA regulations and its continued sale of compounded semaglutide after the agency had declared the shortage resolved in April 2025.

This breach of partnership terms was not unforeseen. The FDA's April 2025 announcement had already set strict deadlines for compounders: state-licensed pharmacies (Section 503A) could no longer produce semaglutide copies after April 22, while outsourcing facilities (Section 503B) faced a May 22 cutoff. Hims, however, continued to market compounded semaglutide as a Wegovy substitute, leveraging telehealth prescriptions to bypass FDA restrictions.

Data visualization showing a sharp decline from $63.26 to $45.00, with a 34.6% drop on June 23.

Legal Landmines and Shareholder Misstatements

The lawsuits filed by Hagens Berman and Wolf Haldenstein on June 25, 2025, allege that Hims engaged in material misstatements to investors. Key claims include:
1. False Compliance Claims: Hims represented its compounded semaglutide sales as legally compliant with FDA rules, even though post-April 2025 production violated Section 503A/503B restrictions.
2. Omission of Partnership Risks: Despite Novo's escalating concerns over Hims' practices, the company failed to disclose the threat of termination in earnings reports or investor calls.
3. Misleading Revenue Projections: Hims attributed 15% of 2024 revenue to Wegovy sales, but its reliance on counterfeit versions inflated this figure, creating a false impression of growth sustainability.

Moore Law PLLC, leading the investigation, argues these misstatements created a “substantial risk of investor harm,” warranting class-action remedies. The lawsuits, targeting Hims and its executives, seek to recover losses for investors who purchased shares between April 29 (when the FDA announced the shortage resolution) and June 23 (the termination date).

Regulatory and Operational Fallout

The FDA's crackdown on compounded semaglutide has left Hims with no viable path to recoup its Wegovy-related revenue. Novo's termination of the partnership has eliminated access to authentic Wegovy, while Hims' compounded alternatives face enforcement actions for violating:
- Section 503A/503B: Mass production of FDA-approved drug copies is now illegal.
- API Sourcing Rules: Use of unapproved Chinese APIs breaches FDA quality standards.
- Telehealth Compliance: Prescribing compounded drugs without individualized patient need violates “personalization” requirements.

Analysts project further stock declines due to valuation multiple compression and regulatory fines. Hims' CEO, Andrew Dudum, has accused Novo of anticompetitive behavior, but this defense ignores the FDA's explicit warnings about compounded GLP-1 products' risks.

A Call to Action for Shareholders

The stakes are clear:
1. Deadline Urgency: The August 25, 2025, lead plaintiff deadline is non-negotiable. Shareholders who delay risk losing eligibility for settlements.
2. Settlement Potential: If the class-action succeeds, recoveries could total $50–$100 million—substantial for a company with a $750 million market cap.
3. Governance Reforms: Litigation may pressure Hims to replace its leadership or restructure operations to align with FDA rules, stabilizing the business long-term.

Investors should:
- Contact law firms (e.g., Hagens Berman) to file claims promptly.
- Monitor regulatory updates, including FDA enforcement actions against Hims.
- Evaluate holding periods and losses to qualify for recoveries.

Conclusion: A Precarious Balance

Hims & Hers stands at a crossroads: its survival depends on navigating legal liabilities while rebuilding trust with regulators and investors. For shareholders, the path to value recovery is narrow but actionable. The August 25 deadline is a critical juncture—delaying engagement could mean forfeiting rights to compensation. In an era of heightened scrutiny on pharmaceutical compliance, Hims' saga underscores the imperative for investors to act decisively when corporate misstatements and governance failures threaten their capital.

Investors are advised to consult legal counsel immediately to secure their position in pending litigation.