Welcome to our dedicated page for Humacyte news (Ticker: HUMA), a resource for investors and traders seeking the latest updates and insights on Humacyte stock.
Humacyte, Inc. (Nasdaq: HUMA) is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale. Its news flow centers on Symvess, an FDA-approved acellular tissue engineered vessel (ATEV™) for extremity arterial injury when autologous vein graft is not feasible, and on the broader clinical and regulatory progress of its ATEV pipeline.
On this page, readers can follow HUMA news related to vascular trauma, hemodialysis access, peripheral artery disease, and other vascular indications where Humacyte’s acellular tissue engineered vessels are being studied. Company announcements frequently cover clinical trial readouts, such as Phase 2/3 and Phase 3 data in trauma and dialysis access, long-term safety and efficacy publications in peer-reviewed journals, and presentations at major medical meetings including the VEITHsymposium and the American Society of Nephrology’s Kidney Week.
Humacyte also issues updates on healthcare economics analyses in extremity arterial injury, highlighting the cost impact of complications like amputation and conduit infection and positioning Symvess as an alternative when vein is not feasible. Additional news items describe humanitarian and real-world use of Symvess in wartime vascular injuries, as well as outcomes in hospital-acquired vascular complications and high-risk patient subgroups.
Investors and clinicians can use this HUMA news feed to track regulatory milestones, such as the FDA approval of the ATEV in vascular trauma, RMAT and Fast Track designations, and planned marketing authorization applications in new territories. Financial and corporate updates, including credit facilities, registered offerings, and sales agreements, are also reported through company press releases and Form 8-K filings. Bookmark this page for an organized view of Humacyte’s latest disclosures on its bioengineered tissue platform, commercial launch activities for Symvess, and ongoing pipeline development.
Humacyte's Acellular Tissue Engineered Vessel (ATEV) has received its third FDA RMAT designation, this time for advanced peripheral artery disease (PAD). The RMAT designation aims to expedite the development and review of regenerative medicine therapies for serious conditions. This follows the FDA's clearance of a new IND application for ATEV in PAD. ATEV is designed for vascular replacement and repair, being universally implantable and ready off-the-shelf. PAD affects the leg arteries, with many patients lacking suitable autologous veins for bypass. ATEV's availability could significantly improve patient outcomes.
Humacyte has presented positive preclinical data for its BioVascular Pancreas (BVP) program, aimed at treating type 1 diabetes. The BVP uses stem cell-derived islets and Humacyte's acellular tissue engineered vessel (ATEV) technology. Preclinical tests on diabetic mice showed these islets restored normal blood sugar levels without adverse safety events. Additionally, non-human primate models demonstrated islet survival and insulin production over three months. The studies are in collaboration with the Diabetes Research Institute at the University of Miami. Humacyte is continuing preclinical studies to advance the BVP for type 1 diabetes treatment.
Humacyte announced the issuance of four new ICD-10-PCS codes by CMS, effective October 1, 2024, for replacing arteries using Humacyte’s Human Acellular Vessel (HAV). These codes cover procedures for both upper and lower extremities. Humacyte is progressing towards a New Technology Add-on Payment (NTAP) application to CMS. Additionally, Humacyte's FDA Priority Review BLA submission for vascular trauma treatment, supported by Phase 2/3 clinical trial results and real-world use in Ukraine, awaits a decision on August 10, 2024. The HAV, now dubbed the 'acellular tissue engineered vessel' (ATEV), is designed for urgent arterial repair and has shown higher patency rates and lower infection rates compared to synthetic grafts. The ATEV is still investigational and not yet FDA-approved.
Humacyte will present at the Jefferies Global Healthcare Conference on June 6, 2024, in New York, NY. The company's Founder, President, and CEO, Laura Niklason, M.D., Ph.D., will lead the presentation at 1:00 p.m. ET. Humacyte specializes in developing bioengineered human tissues and aims to share significant updates and engage in one-on-one meetings. The event will be held at the Marriott Marquis, and a webcast will be available for a time on Humacyte's website.
Humacyte, Inc. (Nasdaq: HUMA) will be participating in upcoming investor conferences in May, with their top executives representing the company. The conferences include H.C. Wainwright BioConnect Investor Conference and Benchmark's 4th Annual Healthcare House Call Investor Conference. The participation aims to showcase their bioengineered human tissue technology on a commercial scale.
Humacyte, a biotechnology company, announced its first-quarter 2024 financial results, including the acceptance of its Biologics License Application (BLA) for HAV™ by the FDA and a PDUFA date set for August 10, 2024. The company raised $43 million from a public offering and highlighted milestones for the planned U.S. launch of its bioengineered human tissue. Recent accomplishments include FDA inspection completion, Budget Impact Model completion, and hiring a Vice President of Sales. The company presented advancements in the HAV for vascular trauma and dialysis access. Financially, they reported $115.5 million in cash, with no revenue but increased net cash provided from funding arrangements.
Humacyte, Inc. (Nasdaq: HUMA) will announce its first quarter financial results on May 10, 2024. The company focuses on developing bioengineered human tissue at scale. A conference call will follow to provide a corporate and financial update.
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