- FDA review of acellular tissue engineered vessel (ATEV™) BLA for the Treatment of Vascular Trauma is ongoing - - Results from the V007 Phase 3 clinical trial of the ATEV in arteriovenous (AV) access for hemodialysis patients presented at American Society of Nephrology’s Kidney Week 2024 - - Long-term results from the humanitarian program where the ATEV was used to treat vascular injuries suffered during the Ukraine conflict were presented at the U.S. Department of Defense’s foremost scientific meeting - - ...

DURHAM, N.C., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the third quarter ended September 30, 2024, on Friday, November 8, 2024. Management will host a webcast and conference call at 8:30 a.m. ET to discuss recent corporate updates from its acellular tissue engineered vessel (ATEV) programs. Title:Humacyte Third Quar ...

Core Insights - Humacyte, Inc. announced positive results from the V007 Phase 3 clinical trial of its acellular tissue engineered vessel (ATEV) for hemodialysis access, demonstrating superiority over the current standard of care, autogenous fistula, at six and twelve months [1][2][3] Clinical Trial Results - The ATEV showed functional patency rates of 81.3% at six months and 68.3% at twelve months, compared to 66.4% and 62.2% for the AV fistula, respectively [3][4] - The trial involved 242 hemodialysis patients, with a statistically significant joint test for superiority of ATEV versus AV fistula (p=0.0071) [3][4] - ATEV patients experienced a longer duration of hemodialysis over the first twelve months compared to AV fistula patients (p=0.0162) [3] Subgroup Analysis - In female patients (n=70), ATEV had significantly higher six-month and one-year patency rates compared to AV fistula (p<0.0001) and a longer duration of hemodialysis (8.3 months vs. 5.0 months, p=0.0011) [4] - In obese patients (n=93), ATEV also showed significantly higher patency rates and longer duration of hemodialysis (7.7 months vs. 4.5 months, p=0.0020) [4] - Diabetic patients (n=165) receiving ATEV had higher patency rates and longer duration of hemodialysis compared to AV fistula (7.4 months vs. 5.5 months, p=0.0155) [4] Safety Profile - Infection rates were low in both treatment arms, with 9.1% of ATEV patients experiencing access-related infections compared to 9.9% for AV fistula [5] - Treatment-Emergent Adverse Events (TAEEs) occurred in 98.3% of ATEV patients, with thrombosis being the most significant adverse event at 52.1% [5] Company Overview - Humacyte is focused on developing bioengineered human tissues and has a portfolio of ATEVs in late-stage clinical trials targeting various vascular applications [7] - The ATEV has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and is under review for a Biologics License Application for vascular trauma [7]

NEW YORK, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) on behalf of Humacyte stockholders. Our investigation concerns whether Humacyte has violated the federal securities laws and/or engaged in other unlawful business practices. Click here to participate in the action. On August 9, 2024, Humacyte disclosed that the U.S. Food and Drug Adm ...

Humacyte, Inc. (HUMA) closed the most recent trading day at $5.82, moving +1.75% from the previous trading session. The stock outpaced the S&P 500's daily gain of 0.22%. On the other hand, the Dow registered a loss of 0.33%, and the technology-centric Nasdaq increased by 0.76%.The the stock of company has risen by 4.86% in the past month, leading the Medical sector's loss of 3.79% and the S&P 500's gain of 1.47%.Analysts and investors alike will be keeping a close eye on the performance of Humacyte, Inc. in ...

SAN FRANCISCO, Oct. 24, 2024 (GLOBE NEWSWIRE) -- On October 17, 2024, the U.S. Federal Food & Drug Administration (“FDA”) published its April 5, 2024 report addressed to Humacyte’s Chief Operating Officer (Heather Prichard) detailing problems with Humacyte’s facilities. The FDA’s April 5, 2024 report submitted to Prichard appears to potentially contradict her assurances to investors at an earnings call on May 12, 2024 in response to analyst questions. Hagens Berman urges investors in Humacyte, Inc. (NASDAQ: ...

In the latest market close, Humacyte, Inc. (HUMA) reached $5.70, with a +0.53% movement compared to the previous day. This change outpaced the S&P 500's 0.76% loss on the day. Meanwhile, the Dow lost 0.75%, and the Nasdaq, a tech-heavy index, lost 1.01%. Shares of the company have appreciated by 7.39% over the course of the past month, outperforming the Medical sector's loss of 3.35% and the S&P 500's gain of 4.31%. Market participants will be closely following the financial results of Humacyte, Inc. in its ...

DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024. The la ...

DURHAM, N.C., Oct. 04, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it entered into a securities purchase agreement with an institutional investor to purchase approximately $30.0 million worth of its common stock and warrants in a registered direct offering. Under the terms of the securities purchase agreement, the Company has agreed to sell 5,68 ...

The most recent trading session ended with Humacyte, Inc. (HUMA) standing at $5.46, reflecting a +0.09% shift from the previouse trading day's closing. This move lagged the S&P 500's daily gain of 0.4%. At the same time, the Dow added 0.62%, and the tech-heavy Nasdaq gained 0.6%. Heading into today, shares of the company had lost 15.43% over the past month, lagging the Medical sector's loss of 2.27% and the S&P 500's gain of 1.71% in that time. The investment community will be paying close attention to the ...