Kahn Swick & Foti Investigates Humacyte Officers and Directors

Law firm launches probe into alleged violations and failures to disclose material information

Apr. 13, 2026 at 5:21pm

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A close-up photograph of a shiny metal medical device component, floating on a plain white background and dramatically lit to convey a sense of corporate uncertainty and regulatory risk.A medical device component under intense scrutiny as Humacyte faces an investigation into its regulatory compliance.Durham Today

The law firm of Kahn Swick & Foti, LLC (KSF) has initiated an investigation into Humacyte, Inc. (Nasdaq: HUMA) and its officers and directors, citing concerns over the company's failure to disclose material information to shareholders, including issues with its manufacturing facilities and clinical sites that led to a Form 483 from the FDA.

Why it matters

The investigation could lead to legal action against Humacyte's leadership, potentially impacting the company's operations and stock price. It also raises broader questions about transparency and accountability in the biotech industry.

The details

According to KSF, the investigation is focused on whether Humacyte's officers and directors breached their fiduciary duties or violated state or federal laws. The firm cites two key events: Humacyte's August 2024 announcement that the FDA would require additional time to review the company's Biologic License Application (BLA) for its acellular tissue engineered vessel, and the FDA's subsequent October 2024 issuance of a Form 483 citing various manufacturing violations at Humacyte's Durham, North Carolina facility.

  • On August 9, 2024, Humacyte announced the FDA would need more time to review its BLA.
  • On October 17, 2024, the FDA issued a Form 483 citing manufacturing violations at Humacyte's Durham facility.

The players

Kahn Swick & Foti, LLC

A law firm that specializes in securities litigation and has launched an investigation into Humacyte.

Charles C. Foti, Jr.

A partner at Kahn Swick & Foti and the former Attorney General of Louisiana, leading the investigation into Humacyte.

Humacyte, Inc.

A biotech company that develops regenerative medicine products, including an acellular tissue engineered vessel that is the subject of the FDA review.

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What they’re saying

“KSF's investigation is focusing on whether Humacyte's officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws.”

— Charles C. Foti, Jr., Partner, Kahn Swick & Foti

What’s next

The investigation by Kahn Swick & Foti is ongoing, and the law firm is encouraging any individuals with information that could assist in the probe, or long-term Humacyte shareholders who wish to discuss their legal rights, to contact the firm.

The takeaway

This investigation highlights the importance of transparency and accountability in the biotech industry, particularly when it comes to disclosing material information that could impact investors. The outcome of this probe could have significant implications for Humacyte's future operations and shareholder confidence.