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, Inc. (Nasdaq: HUMA) has appointed Diane Seimetz, Ph.D., to its board of directors. Dr. Seimetz brings over 22 years of international drug development experience, including her role as co-founder and CEO of Biopharma Excellence. The board chair, Kathleen Sebelius, emphasizes that her expertise will be crucial as Humacyte moves towards the commercialization of its Human Acellular Vessel (HAV). The HAV, currently in late-stage clinical trials for various vascular applications, has received FDA's Regenerative Medicine Advanced Therapy and Fast Track designations.
Humacyte, Inc. (Nasdaq: HUMA) announced the successful implantation of two Human Acellular Vessels (HAV) in wounded Ukrainian patients as part of its humanitarian initiative. The HAVs were provided to aid in treating vascular trauma injuries, showcasing their durability and infection resistance. The cases of the patients, one with shrapnel and the other with a gunshot wound, contribute to real-world evidence supporting HAV treatment. As a priority designation by the U.S. Secretary of Defense, HAVs are currently under evaluation in a Phase 2/3 trial for vascular trauma.
Humacyte, Inc. (Nasdaq: HUMA) presented data at the American Transplant Congress 2022 indicating that its investigational Human Acellular Vessel (HAV) does not increase calculated panel reactive antibodies (cPRA), a key measure linked to transplant rejection risk. The collected data from over 500 patient-years show no evidence of PRA sensitization in more than 470 patients implanted with the HAV. This suggests improved patient outcomes and validates the HAV's potential as a durable, non-immunogenic option for vascular repair. The HAV is currently in late-stage clinical trials.
Humacyte, Inc. (Nasdaq: HUMA) announced that Dale Sander, CFO, and Heather Prichard, COO, will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 10:30 a.m. ET in Miami. The conference will be available both in-person and virtually. Humacyte is a clinical-stage biotechnology company focused on developing bioengineered human tissues for medical applications. Their product, human acellular vessels (HAVs), is in late-stage clinical trials and has received FDA designations for vascular trauma and hemodialysis access.
Humacyte announced Q1 2022 financial results and recent achievements, including shipping Human Acellular Vessels (HAVs) to six hospitals in Ukraine for treating vascular trauma, amidst ongoing humanitarian efforts. Newly appointed Chief Medical Officer Shamik Parikh will lead clinical development. Financial highlights show a revenue increase to $233,000, with a net loss of $19.8 million, slightly down from $20.3 million in Q1 2021. The company has cash reserves of $206.2 million, sufficient to fund operations through 2024, supporting their plans for HAV market entry.
Humacyte, Inc. (Nasdaq: HUMA) has initiated the shipment of Human Acellular Vessels (HAVs) to six hospitals in Ukraine, addressing vascular injuries in civilians and soldiers. This initiative follows a request from Ukrainian surgeons and involves coordination with the FDA and Ukraine's Ministry of Health. The HAV is under evaluation in Phase 2/3 trials for vascular trauma and has received priority designation from the U.S. Secretary of Defense. Although investigational, this effort aims to gather real-world evidence of the HAV's potential benefits.
Humacyte, Inc. (Nasdaq: HUMA) will release its financial results for Q1 2022 on May 13, 2022, followed by a webcast at 8:00 a.m. ET for a corporate update. The company specializes in developing bioengineered human tissues, particularly human acellular vessels (HAVs), which are in late-stage clinical trials for various vascular applications. The HAV has received FDA designations for its significant medical potential, including RMAT and Fast Track status. This webcast will be accessible for 30 days post-event on their website.
Humacyte, Inc. (Nasdaq: HUMA) has appointed Shamik J. Parikh, M.D., as its Chief Medical Officer. Dr. Parikh, who brings over 20 years of experience in clinical development and product launches, will oversee Humacyte's global clinical development strategy. His expertise will be crucial as the company advances its Human Acellular Vessel (HAV) through late-stage clinical trials for vascular applications. CEO Laura Niklason emphasized that Dr. Parikh's background in patient safety and drug strategy will be invaluable in progressing their bioengineered tissue products.
Humacyte, Inc. (Nasdaq: HUMA) will hold its 2022 annual meeting of shareholders virtually on June 9, 2022, at 7:30 AM ET. The record date for eligible voters is April 18, 2022. Humacyte is focused on developing a platform for universally implantable bioengineered human tissues, with an emphasis on human acellular vessels (HAVs). These vessels are in late-stage clinical trials for vascular applications, receiving FDA's Regenerative Medicine Advanced Therapy designation, and are prioritized for vascular trauma by the U.S. Secretary of Defense.
Humacyte, Inc. (HUMA) reported financial results for Q4 and the year ending December 31, 2021, showing a revenue increase to $177,000 in Q4 from $124,000 year-over-year. The company is advancing its Human Acellular Vessel (HAV) clinical trials, with 50 patients enrolled in a Phase 2/3 trial for vascular trauma. Expected BLA filings for HAV in 2022/2023 and a strong financial position with cash of $225.5 million highlight growth potential. Notable partnerships, including with Fresenius Medical Care, support its market strategy.
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