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Humacyte Inc (NASDAQ: HUMA) opened close to 25% up on Monday after the Food & Drug Administration granted its ATEV a special advanced-therapy designation. 

Shares of the biotech firm are still down some 30% versus their year-to-date high. 

The Acellular Tissue Engineering Vessel of the company based out of North Carolina, United States caters to patients with advanced peripheral artery disease. 

ATEV is implantable and is used in vascular replacement and repair. Dr. Cindy Cao – the chief regulatory officer of Humacyte said in a press release today:

We are excited that this additional designation has been granted in advanced PAD, as we expect it will further strengthen our communication with the FDA and expedite the development of our ATEV.

Humacyte stock does not pay a dividend at writing. 

The advanced-therapy designation will enable close interactions with the U.S. regulator and allow for a priority review of the company’s biologics license application. 

On Monday, the FDA also cleared an IND (investigational new drug) application for ATEV in patients for peripheral artery disease as well. According to Dr. Cindy Cao:

We are very pleased to receive our third RMAT (regenerative medicine advanced therapy) designation from the Food and Drug Administration. 

Note that ATEV has not received approval for sale by any regulatory agency in the world so far. Wall Street currently has a consensus “buy” rating on Humacyte stock with upside to $8.70 (up another 35% from here) on average. 

In May, Humacyte reported $31.9 million in net loss for its first financial quarter – down from $37 million a year ago. Analysts, however, had called for an even narrower $25.78 million loss. 

The biotech firm is yet to report a quarterly revenue. Experts had forecast it to post $0.02 million in revenue for its Q1. Laura Niklason – its chief executive said at the time:

Among our recent accomplishments is the completion of a Budget Impact Model illustrating the potential economic value of the HAV compared to current standard of care in vascular trauma.

HUMA had just over $115 million in cash and equivalents at the end of March, 2024. A year ago, it had $80.4 million only. Operating expenses remained sequentially unchanged at about $26.6 million for Humacyte in the first quarter indicating strategic expansion with controlled spending. 

Note that Humacyte shares traded at a high of over $14 during the COVID pandemic in 2021. 

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