Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.
Humacyte on Friday announced that the FDA will need more time to review its investigational acellular tissue engineered vessel, which the company is proposing for the treatment of vascular trauma. The regulator was initially scheduled to release its verdict by Aug. 10.
The FDA—which informed Humacyte of the delay on Friday—did not specify how long it needs to extend its review period and has not yet provided the company a new target action date. The company’s shares dropped as much as 18% in after-hours trading Friday, according to SeekingAlpha.
Humacyte CEO Laura Niklason in a statement said that the FDA has conducted several visits of the company’s clinical sites and manufacturing facilities during the review period, as well as engaged with the biotech in “multiple discussions” regarding the application “including post-marketing and labelling discussions.”
Given these interactions, Niklason said that Humacyte is “confident in the approvability” of the acellular tissue engineered vessel (ATEV), noting that the FDA representatives “expressed an apology” for the delay in the review.
ATEV is a potential first-in-class bioengineered human tissue that can be used for arterial replacement and repair. The investigational device—designed to be universally implantable—can be available off-the-shelf and does not require harvesting veins from trauma patients, which not only takes additional surgical time but also introduces further injuries to a patient.
Humacyte backed its Biologics License Application with data from the pivotal Phase II/III V005 study, which showed that ATEV resulted in “superior function and patency” in hemodialysis patients. At six months, 81.3% of those in the ATEV arm achieved functional patency compared to 66.4% in patients who received arteriovenous fistula, the current standard of care.
At 12 months, the frequency of secondary patency in the ATEV arm dropped to 68.3% but remained greater than arteriovenous fistula comparators, who showed patency of 62.2%. A joint test for superiority showed that ATEV hit statistical significance versus the standard of care.
Humacyte should have enough cash to weather Friday’s regulatory delay. In its first-quarter 2024 report, issued in May, the company said that it had $115.5 million in cash and cash equivalents which “will be adequate to finance operations for at least 12 months.”
