Benchmark has reiterated a Buy rating and a $15.00 price target on shares of Humacyte (NASDAQ: HUMA).
The firm has updated its models following the company's second-quarter filings. Humacyte is currently awaiting further information from the FDA regarding its Biologic License Application (BLA) for its Acellular Tissue Engineered Vessel (ATEV) intended for vascular trauma treatment.
Humacyte's management has expressed confidence in the ATEV's approvability for treating vascular trauma, based on their interactions with the FDA. They are now anticipating a revised action date. While the company awaits this information, it is actively preparing for the commercial launch of ATEV and advancing other programs in its pipeline.
The company's pipeline includes potential treatments for a range of surgical procedures that require vascular grafts. These procedures cover a broad spectrum, from trauma reconstruction and vascular access for dialysis patients to peripheral arterial disease repair. In the future, the company aims to expand its offerings to include coronary artery bypass grafts and a BioVascular Pancreas (BVP).
In other recent news, Humacyte, a biotechnology platform company, reported a net loss of $56.7 million for the second quarter of 2024. Despite the financial setback, the company highlighted significant progress in its product pipeline, including encouraging results from the Phase 3 trial of its Acute Tissue Engineered Vascular (ATEV) product. The U.S. Food and Drug Administration (FDA) has, however, postponed the review of the ATEV for vascular trauma, causing uncertainty about the new timeline for approval.
TD Cowen continues to hold a positive outlook on Humacyte, maintaining a Buy rating for the company. The firm's confidence is reinforced by the impressive results from Humacyte's humanitarian program in Ukraine, which demonstrated high rates of patency and successful infection avoidance with the use of ATEV.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.