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Humacyte Faces Class Action Lawsuit Over Alleged Misconduct
San Francisco, California–Humacyte, a biotechnology firm specializing in regenerative medicine, is currently embroiled in a class action lawsuit initiated by investors who claim the company failed to provide accurate information regarding its flagship product and the regulatory adherence of its manufacturing facilities.
The law firm Hagens Berman is encouraging shareholders of Humacyte (NASDAQ: HUMA) who have experienced significant financial losses to come forward. The timeframe for the class period is noted as May 10, 2024, to October 17, 2024, with a deadline for lead plaintiffs set for January 17, 2025. More details can be found on their official website.
According to the lawsuit, Humacyte and several of its executives allegedly did not disclose important negative information pertaining to the company’s operations and future prospects. Specific allegations include that the manufacturing facility located in Durham, North Carolina, faced serious compliance problems, such as quality assurance shortcomings and issues uncovered during microbial testing.
This situation escalated when the FDA conducted an inspection of the Durham facility, which resulted in a postponement of the review process for Humacyte’s Biologic License Application (BLA) concerning its acellular tissue engineered vessel (ATEV). Notably, on August 9, 2024, the company indicated that the FDA required additional time to finalize its review of the BLA, and later, on October 17, 2024, the FDA released a Form 483 outlining several violations detected at the facility.
In the wake of these disclosures, Humacyte’s stock value saw a drastic drop, prompting Hagens Berman to initiate an investigation into the claims made in the lawsuit.
Reed Kathrein, the Hagens Berman partner leading the investigation, stated, “It seems investors may have suffered due to Humacyte’s alleged failure to reveal crucial information regarding its business operations. Should the allegations prove accurate, this could represent a serious breach of securities laws.”
Investors who have put funds into Humacyte, as well as anyone who might have information relevant to the investigation, are encouraged to share their losses. For those possessing non-public insights about Humacyte, there are pathways available through the SEC Whistleblower program that could potentially yield rewards of up to 30% from any recoveries achieved by the SEC.
For further information and answers to common inquiries regarding this case and the ongoing investigation, interested parties can access additional resources.
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About Hagens Berman
Hagens Berman is a noteworthy global plaintiffs’ rights law firm dedicated to complex litigation, advocating for corporate responsibility. The firm represents a range of clients including investors, whistleblowers, and consumers, consistently achieving notable outcomes for those affected by corporate misconduct. Hagens Berman boasts a proven track record, having secured upwards of $2.9 billion in related cases. For more information about the firm and its accomplishments, visit their official website.
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