Humacyte facility inspection likely not root cause of BLA delay, says TD Cowen

TD Cowen notes that Humacyte (HUMA) shares were under pressure yesterday after Form 483 observations from the FDA manufacturing facility inspection were made public. However, the firm assumes the company resolved the “minor items months” ago and though it was not in contact with management, TD does not believe these observations remain outstanding and are not the root cause of the delay in the BLA approval decision, the analyst tells investors. TD Cowen keeps a Buy rating and $10 price target on Humacyte shares, which fell 16% to close at $4.86 on Thursday and is up 37c, or nearly 8%, to $5.23 in Friday pre-market trading.