Organogenesis Holdings Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Organogenesis Holdings Inc. (ORGO)

If you purchased or acquired Organogenesis Holdings securities between May 2024 and September 2025, you may be eligible to join this securities investigation and seek compensation.

About Organogenesis Holdings

Organogenesis Holdings, headquartered in Canton, MA, is a biotechnology company focused on developing and manufacturing regenerative medicine products.

The company’s primary pipeline asset, ReNu, is designed to address knee osteoarthritis and has been a central focus of its clinical and commercial strategy.

Potential Concerns Under Investigation

Lawyers are investigating whether Organogenesis Holdings and its executives made misleading statements or failed to disclose key information about the company’s ReNu clinical program and its prospects for regulatory approval.

On May 2, 2024, Organogenesis announced that its first Phase 3 ReNu trial achieved its primary endpoint with statistical significance. Management called the results a “milestone achievement” and said the company would meet with the FDA to discuss approval. Attorneys are reviewing whether those statements omitted known risks related to the second ongoing Phase 3 trial.

Executives allegedly continued to issue positive statements throughout 2024 and 2025. On May 9, 2024, the company expressed strong optimism about ReNu’s market potential and its ability to transform the business. On August 8, 2024, Organogenesis reported that enrollment for the second Phase 3 trial had been completed ahead of schedule and projected submission of a Biologics License Application by the end of 2025.

Attorneys may review whether these public statements presented a balanced assessment of clinical risks or omitted adverse information known internally.

On November 11, 2024, an interim analysis described the second Phase 3 trial as “in the favorable zone” and consistent with statistical assumptions. However, after markets closed on September 25, 2025, the company disclosed that the trial failed to meet its primary endpoint, and investors reacted sharply to the news.

On September 26, 2025, Organogenesis shares fell $0.58, or 12.39%, to close at $4.10, causing substantial harm to investors. Attorneys are evaluating whether Organogenesis’ alleged upbeat statements and omissions may have caused investors to purchase shares at inflated prices.

Your Rights and Next Steps

Investors who purchased Organogenesis Holdings securities between May 2024 and September 2025, and suffered losses, may have important legal rights. This is an active investigation, not a filed lawsuit. However, if evidence supports potential securities law violations, a class action lawsuit could follow.

Lawyers are ready to help investors understand their options and evaluate whether their losses are linked to the issues under investigation. Participating in the investigation does not require any upfront payment, and investors’ identities can be kept confidential. If a class action is filed, eligible investors may be able to recover a portion of their losses.

It is important to act promptly, as securities investigations are time-sensitive. Investors who act early may have a stronger voice in the process and help ensure that their interests are represented.

You May Be Entitled to Compensation

If you purchased Organogenesis Holdings securities during the relevant period and experienced financial losses, you may be eligible to join this potential class action investigation and seek compensation. Time is of the essence, as securities investigations often move quickly.

To learn more about your rights and to participate in the investigation, complete the form below.