The litigation focuses on Humacyte’s statements about the FDA’s inspections and the company’s disclosures about its communications with the FDA’s inspections, particularly about the FDA’s inspections of the company’s facilities for the manufacture of its tissue engineered vessel (ATEV) in the vascular trauma indication.
On May 12, 2024, during the company’s Q1 2024 earnings call, an analyst specifically questioned Humacyte management about the company’s facility inspection with the FDA. Humacyte’s Chief Operating Officer (Heather Prichard) said in part that “our manufacturing facility and had a very successful outcome[] [a]nd based on the outcome of inspection and all of the other FDA interactions on the whole, we remain very confident in approval of HAV in vascular trauma.”
When Prichard made the above statements, the FDA had on April 5, 2024 sent her a letter on Form 483 which was not published until October 17, 2024 that communicated serious matters listing inspectional observations. The FDA observed in its April 5, 2024 Form 483 that the company’s facility had no microbial quality assurance, inadequate quality assurance, and reciting that under FDA regulations its observer in his or her judgment indicated that the observations consisted in whole or part of filthy, putrid, or decomposed substance or has been prepared, packed or held under insanitary conditions whereby it may have been become contaminated with filth, or whereby it may have been rendered injurious to health.
But on August 12, 2024, Humacyte’s shares plunged 16% on news that the FDA communicated its delay in considering the company’s biologics license application for ATEV. Then, on October 17, 2024 the FDA published its April 5, 2024 Form 483 addressed to Prichard, driving the price of Humacyte shares down another 16%.
CASE TIMELINE
