The executives and directors of biotechnology company Humacyte Inc. have been hit with a shareholder derivative suit in North Carolina federal court alleging the company concealed that its manufacturing facility failed to comply with certain quality assurance practices, leading to delayed regulatory review for its product candidate.
According to the complaint, Humacyte and its executives and directors failed to disclose for several months there were issues at its Durham, North Carolina, manufacturing facilities, such as the absence of microbial testing. These deficiencies were not revealed publicly until the U.S. Food and Drug Administration announced in October 2024 that Humacyte’s facilities were noncompliant.
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