DURHAM, N.C., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Monday, September 30, 2024 at 8:00 AM ET. To register, click here. The event will feature Charles Fox, MD (University of Maryland School of Medicine), Rishi Kundi MD, RPVI, FACS, FSVS (University of Maryland School of Medicine), and YingWei Lum, MD ...

Group 1 - The article discusses the author's extensive background in life sciences, specifically in the research and development of novel Cell & Gene Therapies (CGT) for various clinical needs, including orthopaedics and rare diseases [1] - The author emphasizes the importance of assessing the potential of novel treatments, particularly those utilizing CGT, in driving shareholder returns [1] - The focus of the analysis will be on biotechnology, pharmaceutical, Medtech, and healthcare stocks, providing insights into the companies within these sectors [1]

When deciding whether to buy, sell, or hold a stock, investors often rely on analyst recommendations. Media reports about rating changes by these brokerage-firm-employed (or sell-side) analysts often influence a stock's price, but are they really important? Let's take a look at what these Wall Street heavyweights have to say about Humacyte, Inc. (HUMA) before we discuss the reliability of brokerage recommendations and how to use them to your advantage. Humacyte, Inc. currently has an average brokerage recom ...

Humacyte, Inc. (HUMA) announced a delay in the FDA's review of its Biologic License Application (BLA) for its Acellular Tissue Engineered Vessel (ATEV). The FDA, which had granted a Priority Review to this pioneering vascular trauma treatment, now requires additional time beyond the original Prescription Drug User Fee Act (PDUFA) date of Aug 10, 2024, to complete its evaluation. Despite the delay, Humacyte remains confident about ATEV's potential approval and its transformative role in trauma care. Humacyte ...

Friday, the FDA announced it would require additional time to complete its review of Humacyte Inc.'s HUMA Biologic License Application (BLA) for the acellular tissue-engineered vessel (ATEV) in the vascular trauma indication. The ATEV trauma program BLA was submitted to the FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of August 10, 2024. In a phone call from FDA CBER leadership today, the Company was informed that the FDA required additional time to ...

Core Viewpoint - Humacyte, Inc. announced that the FDA requires additional time to review its Biologic License Application for the acellular tissue engineered vessel (ATEV) intended for vascular trauma, which was initially set for a PDUFA date of August 10, 2024 [1][2] Company Overview - Humacyte is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][4] - The company is working on a portfolio of ATEVs targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease [4][5] - The ATEV is designed to be a first-in-class bioengineered human tissue that serves as a universally implantable vascular conduit for arterial replacement and repair [2][4] FDA Review Process - The FDA granted a Priority Review for the ATEV, which typically allows for a six-month review cycle compared to the standard ten-month cycle for most products [2] - The BLA for ATEV was submitted in December 2023, and the FDA has conducted inspections and engaged in discussions regarding the application [2][4] - The company remains confident in the approvability of the ATEV based on positive results from clinical studies and real-world evidence [2][4] Clinical Evidence - The BLA included results from the V005 pivotal Phase 2/3 clinical study and evidence from treating wartime injuries in Ukraine [2] - ATEV has been used in various traumatic injury cases, demonstrating high rates of patency and low rates of amputation and infection [2][4]

Additionally, investors should keep an eye on any recent revisions to analyst forecasts for Humacyte, Inc. Such recent modifications usually signify the changing landscape of near-term business trends. With this in mind, we can consider positive estimate revisions a sign of optimism about the company's business outlook. Heading into today, shares of the company had gained 63.73% over the past month, outpacing the Medical sector's gain of 0.37% and the S&P 500's gain of 1.96% in that time. Research indicates ...

– Third RMAT designation by FDA for ATEV – DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Inve ...

DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Investigational New Drug (IND) application for ...

– BioVascular Pancreas (BVP) product candidate is under development as a potential treatment for type 1 diabetes – – Humacyte's stem cell-derived islets observed to restore normal blood glucose in diabetic mice – – Non-human primate models of BVP implantation showed islet survival and continued insulin production – DURHAM, N.C., June 25, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinicalstage biotechnology platform company developing universally implantable, bioengineered human tissues at com ...