Humacyte concerns raised in 483 not that big a deal, says Piper Sandler

Piper Sandler analyst Allison Bratzel keeps a Neutral rating on Humacyte (HUMA) after an early-April Form 483 was made available yesterday by the FDA. The firm does not think the concerns raised by FDA “are that big of a deal,” and notes the company indicates they have already been addressed. That said, Piper does not think manufacturing-related concerns could be ruled out as a reason for the Acellular Tissue Engineered Vessel FDA action data delay back in August. With the ATEV application “still in FDA limbo,” coupled with a cautious view on the potential commercial launch of the ATEV in vascular trauma, Piper remains comfortable on the sidelines on Humacyte shares.