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 clinical-stage biotechnology pioneer developing universally implantable bioengineered human tissues for vascular repair and regenerative medicine. This dedicated news hub provides investors and medical professionals with essential updates on clinical advancements, regulatory milestones, and strategic developments.
Access timely press releases and analysis covering HUMA's progress in vascular trauma solutions, hemodialysis access innovations, and peripheral artery disease treatments. Our curated collection includes updates on FDA designations, trial results, manufacturing partnerships, and scientific publications - all critical for evaluating the company's position in advanced tissue engineering.
Key focus areas include acellular tissue platform developments, late-stage clinical trial outcomes, and commercialization strategies for shelf-ready vascular conduits. Bookmark this page to efficiently track Humacyte's progress in transforming surgical practices through its disruptive approach to regenerative medicine.
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company, has announced a $30.0 million registered direct offering of common stock and warrants. The company will sell 5,681,820 shares of common stock and warrants to purchase an equal number of shares. The warrants are divided into two tranches, both with an exercise price of $5.28 per share, expiring at different intervals. The purchase price for one share and one warrant is set at $5.28. The offering is expected to close around October 7, 2024, subject to customary conditions. EF Hutton is acting as the exclusive placement agent for this offering, which is being made under a previously filed and effective shelf registration statement.
Humacyte (Nasdaq: HUMA) has announced a virtual Key Opinion Leader (KOL) event scheduled for September 30, 2024 at 8:00 AM ET. The event will focus on case studies evaluating Humacyte's acellular tissue engineered vessel (ATEV) product candidate for vascular trauma treatment.
Featured speakers include Dr. Charles Fox and Dr. Rishi Kundi from the University of Maryland School of Medicine, and Dr. YingWei Lum from Johns Hopkins School of Medicine. They will discuss the unmet medical needs and current treatment landscape for urgent arterial repair after extremity vascular trauma.
The event will highlight case studies from a Phase 3 trial conducted in the United States and Israel, as well as treatments of warfighters under a humanitarian program in Ukraine. Humacyte's ATEV is described as an investigational, first-in-class bioengineered human tissue designed as a universally implantable vascular conduit for arterial replacement and repair.
Humacyte (Nasdaq: HUMA) announced the allowance of a U.S. Patent for its BioVascular Pancreas (BVP) product candidate, designed to treat type 1 diabetes. The patent covers the BVP's design and composition, which uses Humacyte's acellular tissue engineered vessel (ATEV™) to deliver insulin-producing islets inside the body. Positive preclinical results support the BVP's potential:
1. Stem cell-derived islets restored normal blood sugar in diabetic mice
2. Successful BVP implantation in non-human primates showed islet survival and continued insulin production for three months
With 1.45 million Americans living with type 1 diabetes and 64,000 new diagnoses annually, the BVP could potentially overcome current hurdles in islet implantation for diabetic patients.
Humacyte (Nasdaq: HUMA), a clinical-stage biotechnology company, has announced its participation in two upcoming investor conferences in September 2024. The company, which focuses on developing universally implantable, bioengineered human tissue at commercial scale, will be represented by Laura Niklason, M.D., Ph.D., Founder, President, and CEO, and Dale Sander, CFO.
The conferences are:
- H.C. Wainwright 26th Annual Global Investment Conference on Tuesday, September 11, 2024, from 8:30 - 9 AM ET
- Cantor Global Healthcare Conference on Wednesday, September 18, 2024, from 9:10 - 9:40 AM ET
Both events will feature company presentations, with webcasts available for interested parties to view online.
Humacyte (Nasdaq: HUMA) presented positive long-term results from a humanitarian program in Ukraine using their investigational acellular tissue engineered vessel (ATEV) to treat vascular injuries. The study, known as the 'V017 trial', showed high rates of patency and avoidance of amputation and infection in severe wartime injuries.
Key findings include:
- 12-month primary and secondary patency rates of 87.1%
- Zero instances of ATEV infections, amputations, or deaths
- Mean follow-up duration of 357.9 days
- Only one event of ATEV thrombosis after month six
- No reports of ATEV aneurysm or pseudo-aneurysm
The ATEV is designed as an off-the-shelf, universally implantable vascular conduit for arterial replacement, repair, and hemodialysis access. It is still investigational and not yet approved for sale by the FDA or other regulatory agencies.
BioAesthetics has appointed Dr. Juliana Blum as its new Chief Executive Officer, effective August 12, 2024. Dr. Blum, co-founder and former EVP of Corporate Development at Humacyte (NASDAQ: HUMA), brings 20 years of experience in biotech development and commercialization. Her expertise includes global regulatory affairs, CMC development, and manufacturing scale-up.
BioAesthetics, a biotechnology company focused on biomaterials advancements, is developing the NACgraft™ biologic matrix, an acellular tissue graft for nipple regeneration in breast reconstruction patients. The company is also working on a drug-eluting graft technology for soft tissue reconstruction. Dr. Blum's appointment is seen as a strategic move to guide the company's products towards clinical trials and commercialization.
Humacyte (Nasdaq: HUMA) reported Q2 2024 financial results and business updates. Key highlights include:
1. FDA requires additional time to review ATEV™ BLA for vascular trauma treatment.
2. Positive topline results from Phase 3 trial of ATEV in hemodialysis access, showing superior functional patency over standard care.
3. ATEV received third RMAT designation from FDA for advanced peripheral artery disease.
4. Q2 2024 financial results: No revenue, R&D expenses $23.8M, G&A expenses $5.7M, net loss $56.7M.
5. Cash and cash equivalents of $93.6M as of June 30, 2024.
The company remains confident in ATEV's approvability for vascular trauma treatment despite the FDA review extension.
Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology company developing universally implantable, bioengineered human tissue, will release its Q2 2024 financial results on August 13, 2024. The company 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. Investors can join via phone (U.S.: 1-877-704-4453, International: 1-201-389-0920, Conference ID: 13747913) or webcast. A replay will be available on the company's investor website for at least 30 days after the event.
Humacyte (Nasdaq: HUMA) announced that the FDA requires additional time to review its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in vascular trauma treatment. The FDA granted Priority Review in February 2024 with a PDUFA date of August 10, 2024. Despite active engagement and inspections, the FDA couldn't complete the review by the PDUFA date due to ATEV being a first-in-class product.
ATEV is designed as a universally implantable vascular conduit for arterial replacement and repair, available off-the-shelf. The BLA included positive results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from Ukraine. ATEV showed high patency rates and low amputation and infection rates in both civilian and military clinical studies.
Humacyte (Nasdaq: HUMA) announced positive top-line results from its V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV) for arteriovenous access in hemodialysis patients. The ATEV demonstrated superior function and patency at six and 12 months compared to the current standard of care, autogenous fistula.
Key findings include:
- 81.3% of ATEV patients had functional patency at 6 months vs 66.4% for AV fistula
- 68.3% of ATEV patients had secondary patency at 12 months vs 62.2% for AV fistula
- ATEV patients achieved significantly longer duration of hemodialysis over 12 months
Humacyte plans to discuss potential market authorization with the FDA soon and present detailed results at upcoming medical conferences.
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