Humacyte’s (HUMA) Statements to Investors Called Into Question in Light of FDA Violations – Hagens Berman

SAN FRANCISCO, Oct. 28, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (NASDAQ: HUMA), a biotechnology company focused on developing acellular tissue engineered vessels, has faced significant setbacks in recent months due to regulatory scrutiny from the U.S. Food and Drug Administration (FDA). The company’s stock price has plummeted following disclosures of FDA violations at its manufacturing facility and delays in the approval process for its flagship product.

Hagens Berman urges investors in Humacyte who suffered substantial losses to submit your losses now.

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Investigation Into Humacyte, Inc. (HUMA):

On August 9, 2024, Humacyte announced that the FDA would require additional time to review its Biologic License Application (BLA) for its acellular tissue engineered vessel (ATEV) in the vascular trauma indication. This news sent shockwaves through the market, leading to a 16% decline in the company’s stock price.

Then, on October 17, 2024, the FDA disclosed in a Form 483 that a number of violations were found at Humacyte’s Durham, North Carolina facility during an inspection performed by the FDA on April 1 through April 5, 2024. The violations cited by the FDA include, among other things, references to “no microbial quality assurance,” “no microbial testing,” and “inadequate” quality oversight at the facility for a number of issues. On this news, the price of Humacyte shares fell more than 16%.

Shareholder rights firm Hagens Berman is investigating the accuracy of Humacyte’s prior public statements and whether the company may have violated the U.S. securities laws.

As recently as May 12, 2024, when questioned by analysts at the company’s first quarter earnings call about the FDA’s facility inspection and any observations or corrections that needed to be made, Humacyte executives claimed that the inspection was “very successful” and that they remained “very confident” in the approval of their product.

“The discrepancies between the executives’ assurances and the FDA’s findings raise concerns about the company’s transparency and its commitment to regulatory compliance,” said Reed Kathrein, the Hagens Berman partner leading the firm’s investigation.

If you invested in Humacyte or have knowledge that may assist the firm’s investigation, submit your losses now »

If you’d like more information and answers to frequently asked questions about the Humacyte investigation, read more »

Whistleblowers: Persons with non-public information regarding Humacyte should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].

About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. 

Contact:
Reed Kathrein, 844-916-0895

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