Humacyte issues raised in 483 appear ‘fixable,’ says BTIG

BTIG keeps a Buy rating on Humacyte (HUMA) with a $10 price target after the FDA published a Form 483 notifying the company of findings from facility inspections in early April. While Humacyte has not specifically spoken on the details from FDA inspections, management’s prior commentary alluded to several “follow-up items” from the agency they were in the process of addressing, the analyst tells investors in a research note. BTIG says that while the FDA update “is not ideal,” the issues that have been raised “appear to be fixable.” Form 483s are not a “no” on approval but they create uncertainty around the timing of the approval and Humacyte’s ability to eventually commercialize the product, adds the firm.