Real-world evidence from its humanitarian use in Ukraine to treat wartime injuries further bolstered the company’s biologics license application.
Humacyte Inc. shares surged over 70% early on Friday, reaching their highest levels in over a month amid skyrocketing retail interest.
Trading volume was over six times the daily average, as the ticker climbed to the top of Stocktwits’ trending symbols tab.
The rally follows the company’s announcement late Thursday that the FDA granted full approval for Humacyte’s Symvess, a bioengineered human tissue designed as a universally implantable vascular conduit for arterial replacement and repair.
The approval specifically applies to its use in extremity arterial injuries where urgent restoration of blood flow is needed to prevent limb loss, especially when vein grafts are not feasible.
The FDA’s decision was based on positive results from Humacyte’s pivotal Phase 2/3 V005 clinical study, which demonstrated Symvess’s high patency rates and low risks of infection and amputation.
Real-world evidence from its humanitarian use in Ukraine to treat wartime injuries further bolstered the company’s biologics license application.
The company said the product has been employed in a variety of trauma scenarios, including car accidents, gunshot wounds, and blast injuries, by surgeons in the U.S., Israel, and frontline hospitals in Ukraine.
Retail sentiment surged to the highest over the past year on Stocktwits, with message volume reaching ‘extremely high’ levels.
Many bullish investors noted Humacyte’s short interest, which recently stood at 14.6% of the free float according to Koyfin, with speculation that it may have increased.
Some retail watchers even suggested a high likelihood of a significant acquisition, given the transformational potential of Symvess in bioengineered medical devices.
H.C. Wainwright analyst Vernon Bernardino raised Humacyte’s price target to $15 from $12, while maintaining a ‘Buy’ rating, which signals a near tripling from current trading levels.
The stock has gained nearly 19% year-to-date.
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