On Thursday, H.C. Wainwright adjusted its financial outlook for shares of Humacyte (NASDAQ: HUMA), increasing the price target to $15.00 from the previous $12.00 while reaffirming a Buy rating. Currently trading at $3.46, the stock sits well below analyst targets ranging from $6 to $25.
This valuation adjustment came after Humacyte’s recent announcement regarding FDA approval for its medical product, Symvess. According to InvestingPro data, the company has a market capitalization of $445 million and currently shows a weak financial health score.
Humacyte shared news on December 19 that the U.S. Food and Drug Administration (FDA) granted full approval for their product, Symvess, an acellular tissue-engineered vessel (ATEV)-tyod.
Symvess is now approved for use in adults as a vascular conduit in cases of extremity arterial injury when there is an urgent need for revascularization to prevent imminent limb loss and when an autologous vein graft is not an option. InvestingPro analysis reveals the company is rapidly burning through cash, with negative free cash flow of $92.26 million in the last twelve months.
The FDA’s acceptance and Priority Review designation for Humacyte’s Biologics License Application (BLA) for Symvess took place in February 2024. The application was set for a Prescription Drug User Fee Act (PDUFA) action date of August 10, 2024. Following the FDA’s full approval, H.C. Wainwright increased its weighted-probability of success (POS) for Symvess to 70% from the previous 60%.
H.C. Wainwright’s forecast for Symvess sales stands at $17.1 million in 2025. The firm suggests that Humacyte’s stock should be considered a core holding for the next 12 months. The endorsement of the stock and the increased price target reflect the firm’s confidence in the product’s market potential and the company’s future financial performance.
In other recent news, BTIG has maintained its Buy rating and $10 price target for Humacyte, reflecting continued support for the company’s stock as it transitions into the commercial phase of its SYMVESS product.
In financial news, Humacyte reported a decrease in net loss to $39.2 million in Q3 2024, despite not generating any revenue. The company boosted its cash reserves to $71.0 million through a registered direct offering of approximately $30 million.
On the analysts’ front, Humacyte’s developments, including the FDA review of the ATEV Biologics License Application for vascular trauma and the development of the Bioengineered Vascular Patch for Type 1 diabetes, were highlighted by BTIG. The company is also making progress on the VO-12 trial targeting women for dialysis access, in collaboration with Fresenius. These are all recent developments in the company’s operations.
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