Aziyo Biologics Inc. shares hit an all-time low Monday after the U.S. Food and Drug Administration said it wouldn’t approve the company’s next-generation CanGaroo RM product without more data.
Shares fell to $1.23, their lowest level since the company went public in October 2020, before trimming those losses to rise to $1.54 for a decline of nearly 61%.
Aziyo, which filed for FDA approval last year and had expected a green light from the agency by the end of March, said the FDA issued a “not substantially equivalent” notice and called on the company to address items related to drug testing, including a request to modify an in-vitro drug-release assay used as a manufacturing control.
The CanGaroo RM is new version of Aziyo’s FDA-approved CanGaroo product, with the addition of antibiotics to the biomaterial envelope to reduce the risk of bacterial colonization.
The FDA issues “not substantially equivalent” notices when the agency finds that a device isn’t substantially equivalent to one that is already being marketed.
The Silver Springs, Md., biotechnology company noted that the FDA’s review didn’t raise any questions surrounding the appropriateness of the pathway or the majority of the data submitted to support the filing, and that it is confident that it can address the FDA’s questions promptly.