On Monday, Benchmark raised the price target for Humacyte (NASDAQ:HUMA) to $17.00, up from the previous target of $15.00, while maintaining a Buy rating on the stock. Currently trading at $4.47, the stock sits well below analyst targets ranging from $6 to $25.
According to InvestingPro data, Humacyte has delivered an impressive 61% return over the past year. The revision follows the company's announcement that it received full FDA approval for its SYMVESS product, which is designed for use in adults requiring urgent revascularization to prevent imminent limb loss, when an autologous vein graft is not feasible.
The FDA's final labeling for SYMVESS omits any reference to synthetic graft materials, a development the analyst noted as being more favorable than expected. This decision was influenced by data from a study published in JAMA Surgery on November 20, demonstrating SYMVESS's superiority over synthetic grafts.
Humacyte anticipates receiving approval for the improved labeling in roughly 8 weeks, positioning the commercial launch of SYMVESS for the first quarter of 2025. In light of this advancement, Benchmark has adjusted its revenue forecast and valuation assumptions for Humacyte, leading to the increased price target.
The analyst also highlighted that the FDA's approval mitigates the regulatory risks associated with Humacyte's new product pipeline. While the company shows promise, InvestingPro analysis indicates the company is currently burning through cash with negative EBITDA of $105 million in the last twelve months. InvestingPro subscribers have access to 8 additional key insights about Humacyte's financial health and growth prospects.
The firm upholds its positive outlook on Humacyte's potential to capture a significant market share in the domain of surgical procedures that necessitate vascular grafts. This includes applications in trauma reconstruction, vascular access for dialysis, peripheral arterial disease repair, and potentially in coronary artery bypass grafts and a BioVascular Pancreas (BVP).
Benchmark reiterates its Buy rating for Humacyte, reflecting confidence in the company's market prospects following the FDA's approval of SYMVESS. With a beta of 1.38, the stock shows moderate market sensitivity.
For a comprehensive analysis of Humacyte's valuation and growth potential, including exclusive Fair Value calculations and detailed financial metrics, explore the full research report available on InvestingPro.
In other recent news, Humacyte Inc. has received full FDA approval for its bioengineered human tissue product, SYMVESS. The approval is based on clinical trials that demonstrated high rates of patency and low rates of amputation and infection. This development marks a significant advancement in regenerative medicine and trauma care, providing a new treatment option for patients with arterial injuries.
Following the FDA's approval, H.C. Wainwright analyst Vernon Bernardino raised his price target on Humacyte stock to $15 from $12, indicating an increased probability of success for SYMVESS. Meanwhile, BTIG reaffirmed its Buy rating and $10.00 price target for Humacyte. Despite not generating any revenue, Humacyte reported a decrease in net loss to $39.2 million in Q3 2024, and successfully raised approximately $30 million through a registered direct offering, boosting its cash reserves to $71.0 million.
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