Humacyte, INC 8-K filings

Humacyte, Inc. has entered into a purchase agreement with Lincoln Park Capital for up to $50 million in common stock sales, providing flexible funding for its operations.

Humacyte reports an FDA delay in the review of its ATEV for vascular trauma, while also announcing positive Phase 3 trial results for hemodialysis access and a third RMAT designation.

Humacyte's acellular tissue engineered vessel (ATEV) showed superior results compared to the standard autogenous fistula in a Phase 3 clinical trial for hemodialysis access.

Humacyte's 2024 Annual Meeting saw the election of six Class III directors and the ratification of PricewaterhouseCoopers LLP as the independent auditor.

Humacyte announced its first quarter 2024 financial results, highlighted by the FDA granting priority review for its Biologics License Application (BLA) for the Human Acellular Vessel (HAV) in vascular trauma.

Humacyte's bioengineered human tissue, HAV, received FDA priority review for vascular trauma, supported by positive clinical trial results and real-world evidence.

Humacyte, a clinical-stage biotechnology company, has announced a public offering of 13.4 million shares of its common stock at $3.00 per share, aiming to raise approximately $40.2 million.

Humacyte's bioengineered human acellular vessels (HAVs) are nearing potential market launch after receiving priority review from the FDA, with a PDUFA date set for August 10, 2024.

The FDA has granted Priority Review to Humacyte's Biologics License Application for its Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma.