A federal judge has allowed part of the investor lawsuit against Humacyte, Inc. (HUMA) to proceed, finding that shareholders plausibly alleged misleading statements about the safety and efficacy of its lead product, Symvess, while dismissing, without prejudice, other claims tied to manufacturing readiness and liquidity disclosures.
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The March 31, 2026, ruling from the U.S. District Court for the Middle District of North Carolina granted in part and denied in part Humacyte’s motion to dismiss, meaning the case will proceed on a narrower set of allegations rather than being thrown out entirely.
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What Investors Alleged
Investors brought claims on behalf of people who owned Humacyte common stock or warrants, sold put options, or bought call options between August 14, 2023, and March 25, 2025. They alleged the company and senior executives misled the market about three main issues: the safety and effectiveness of Symvess, the condition of Humacyte’s Durham manufacturing facility, and whether the company had enough liquidity to fund operations.
Symvess, also known as the human acellular vessel or HAV, is a lab-grown blood vessel implant designed for urgent arterial repair following extremity vascular trauma when synthetic grafts are not appropriate, and autologous vein use is not feasible. Humacyte submitted its biologics license application for the product in December 2023.
The FDA later delayed approval beyond the original August 2024 PDUFA date before ultimately approving the product in December 2024 with a narrower indication and a boxed warning highlighting rupture risks.
Product Safety Claims Survive
The court declined to dismiss the Section 10(b) claims for alleged product-safety fraud.
Plaintiffs argued that Humacyte repeatedly highlighted favorable trial results for Symvess while understating serious safety concerns, including rupture risks and disputes over how trial success rates were measured. They also pointed to later reporting describing FDA reviewer objections and internal disagreement over whether the product demonstrated superiority over existing treatment options.
The judge found that the allegations were sufficient at the pleading stage for the product-safety theory to continue, allowing investors to proceed with claims that the company’s statements about Symvess’s safety and efficacy may have been materially misleading.
This does not mean the court found liability. It means only that the allegations were strong enough to survive dismissal and move into the next phase of litigation.
Manufacturing Facility Claims Were Dismissed
The court dismissed without prejudice claims tied to Humacyte’s statements about its manufacturing facility and FDA inspections.
Investors had argued that the company misled the market by portraying its Durham facility as ready for commercial-scale production while failing to disclose FDA Form 483 observations regarding microbial quality assurance and oversight.
The judge found the stronger inference was that the defendants reasonably believed they could resolve those manufacturing issues before the FDA decision or that the issues would not prevent approval. Because plaintiffs did not plead a strong enough inference of scienter, those facility-related securities fraud claims were dismissed without prejudice.
Liquidity Claims Also Dismissed
The court also dismissed the liquidity-related fraud claims without prejudice.
Plaintiffs argued that Humacyte gave investors an overly optimistic picture of its cash position and failed to adequately disclose its reliance on financing from Oberland Capital Management. After the FDA approval delay, Humacyte later disclosed substantial doubt about its ability to continue as a going concern without additional financing and raised more capital through discounted offerings.
Still, the court concluded the allegations were more consistent with management holding a good-faith belief in its 12-month liquidity projections and then reacting to an unexpected approval delay by raising capital. The judge said the complaint did not sufficiently show Humacyte lacked a reasonable basis for those projections when made.
Claims Against Executives Narrowed But Continue
Because the product safety claims survived, related control-person claims under Section 20(a) against CEO Laura Niklason, CFO Dale Sander, and COO Heather Prichard also remain alive.
However, Section 20(a) claims tied to the dismissed facility and liquidity theories were also dismissed without prejudice. The court explained that liability under Section 20(a) depends on an underlying viable Section 10(b) claim.
What Happens Next
The case now moves forward focused primarily on whether Humacyte and its executives misled investors about Symvess’s safety profile and clinical performance during the class period.
Discovery and further motion practice will likely center on what management knew about FDA concerns, trial outcomes, and rupture risks before approval. The surviving claims have not been proven, and the court’s ruling is not a finding that defendants committed fraud.
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