Humacyte Stock Soars Over 50% Following FDA Approval

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Humacyte Stock Soars Over 50% Following FDA Approval

Investing.com -- Humacyte Inc. shares surged by 56% in pre-opening trades on Friday following the announcement that the company's SYMVESS product received full approval from the U.S. Food and Drug Administration (FDA). The bioengineered human tissue is designed to be used as a vascular conduit for arterial replacement and repair, representing a significant advancement in regenerative medicine and trauma care.

The FDA's approval of SYMVESS came after it demonstrated high patency rates and low amputation and infection rates in clinical trials. This approval provides a new treatment option for patients with arterial injuries, offering a ready-to-use, universally implantable solution without the need for additional invasive procedures to obtain vascular grafts. The company has also prepared a highly experienced sales team for the upcoming commercial launch.

Known as ATEV™, SYMVESS is the first product in its class to show positive results in both civilian and military clinical studies, including those involving war injuries in Ukraine. The technology is seen as a game-changing product, especially in war zones where infections are common and alternatives to autologous vein grafts are limited.

Following the FDA approval, H.C. Wainwright analyst Vernon Bernardino raised his price target for Humacyte shares from $12 to $15. Bernardino believes the approval has significantly increased the likelihood of success for SYMVESS, stating, "We are raising our weighted probability of success (POS) assumption for Symvess from 60% to 70%. We anticipate that Symvess will generate $17.1 million in sales by 2025. We recommend considering Humacyte shares as a foundational investment over the next 12 months."

The company's trajectory has been closely monitored since it was granted Regenerative Medicine Advanced Therapy (RMAT) status in May 2023, followed by receiving Breakthrough Designation status in February 2024. The recent FDA approval is a result of these efforts and positions Humacyte for a strong market entry with its innovative product.

SYMVESS is indicated for adult patients requiring vascular conduits due to extremity arterial injuries, particularly when autologous vein grafts are not applicable, recently aiming to prevent limb loss. This approval may establish a new standard in the treatment of traumatic vascular injuries, which have seen little significant innovation for decades.

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