Friday, the FDA announced it would require additional time to complete its review of Humacyte Inc.’s Biologic License Application (BLA) for the acellular tissue-engineered vessel (ATEV) in the vascular trauma indication.

The ATEV trauma program BLA was submitted to the FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of August 10, 2024.

In a phone call from FDA CBER leadership today, the Company was informed that the FDA required additional time to complete its review. The revised action date is undisclosed.

“We received a call from FDA CBER leadership this afternoon apologizing to us and stating that additional time is required for review,” said Laura Niklason, CEO of Humacyte ( HUMA ).

ATEV is a bioengineered human tissue designed to be a universally implantable vascular conduit for arterial replacement and repair.

Arterial replacement involves a graft to replace or bypass the blocked part of the artery. The graft may be a plastic tube or a blood vessel (vein) taken from your body (most often the opposite leg) during the same surgery.

While harvesting vein from a trauma patient takes valuable surgical time, ATEV is available off the shelf, and does not require further injuring the patient to obtain the needed vascular repair material.

Humacyte’s FDA marketing application included results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program.

The ATEV received priority designation for vascular trauma by the U.S. Secretary of Defense.

Humacyte ( HUMA ) will release its financial results for the second quarter on Tuesday, August 13, and host a conference call to discuss recent corporate updates from its ATEV programs.

Price Action: HUMA stock is down 8.98% at $7.20 during the premarket session at last check Monday.

Illustration of Phrama lab worker created with MidJourney.

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