The legal pressure stems from an August 2024 disclosure in which Humacyte admitted the FDA required more time to review its Biologic License Application for the acellular tissue engineered vessel. The situation intensified in October 2024 when the agency issued a Form 483 for the company’s Durham facility. Inspectors cited critical lapses, specifically noting a lack of microbial quality assurance and testing, alongside inadequate executive oversight.

Following these revelations, shareholders initiated a securities class action lawsuit, alleging that Humacyte and its executives failed to disclose material information regarding company operations. With a federal court recently denying the company’s motion to dismiss the claims, the litigation is moving into a more active phase. The ongoing probe by Kahn Swick & Foti seeks to determine if these failures represent a broader pattern of corporate malfeasance that harmed investor interests.