$HUMA News
Last published 1d ago
- 1d agoHUMAHumacyte Third Quarter 2026 Earnings Conference Call - HUMACYTE INCEarnings Call TranscriptsGood morning, ladies and gentlemen, and welcome to the Humacyte 3rd Quarter 2026 Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and
- 1d agoHUMAHumacyte Third Quarter 2026 Earnings Conference Call - HUMACYTE INCEarnings Call TranscriptsGood morning, ladies and gentlemen, and welcome to the Humacyte 3rd Quarter 2026 Earnings Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and
- 1d agoHUMAHumacyte, Inc. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 2d agoHUMAHumacyte Highlights First-in-Human Coronary Bypass Study at American Heart Association Scientific Sessions 2026GlobeNewswire– Humacyte has initiated the CABG clinical study and looks forward to the commencement of screening for potential patients. – "Moving it into a first-in-human study is the step that will tell us whether an
- 1w agoHUMAHumacyte Innovative Research in Coronary Bypass and Vascular Regeneration to be Highlighted at American Heart Association Scientific Sessions 2026GlobeNewswire– Founder & CEO Laura Niklason, M.D., Ph.D., to deliver invited talk on engineering the microenvironment to accelerate vascular regeneration. – Two additional presentations to cover first-in-human Phase 2a study
- 1w agoHUMAHumacyte To Announce 2026 Third Quarter Financial Results and Provide Business Update on November 10, 2026GlobeNewswireDURHAM, N.C, Nov. 02, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today
- 2w agoHUMAHumacyte Strengthens Intellectual Property Portfolio with Issuance of New U.S. Patent Covering Symvess and Other Bioengineered TissuesGlobeNewswire– Patent provides coverage into 2043 for key aspects of how Symvess is manufactured, sterilized, stored and shipped. DURHAM, N.C., Oct. 28, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage
- 2w agoHUMAHumacyte at ASN Kidney Week: Phase 3 Trial Built for Women Shows ATEV Advantage Over Fistula, Getting Patients Off Catheters Months SoonerGlobeNewswire- The presenter, Dr. Roy-Chaudhury said, "These results give the nephrology community a strong reason to rethink our approach to access decisions for women and, once approved by the FDA, to consider the ATEV as a
- 3w agoHUMAHumacyte Provides Commercial Update and Highlights Rapid Acceleration of Symvess Adoption by HospitalsGlobeNewswire– Hospitals that have ordered Symvess® increased 44% during the third quarter, from 34 at the end of the second quarter to 49 as of September 30, 2026. – Commercial momentum continues to build, driven by expanding
- 1mo agoHUMAHumacyte Announces Phase 3 V012 Trial Results for ATEV in Women Requiring Hemodialysis Access Accepted for a Late-Breaking Session Presentation at ASN Kidney Week 2026GlobeNewswire- Interim Phase 3 findings will be presented in a prestigious late-breaking oral session at the leading meeting for kidney health professionals. – Randomized trial compares the acellular tissue engineered vessel
- 2mo agoHUMAHumacyte to Present at the H.C. Wainwright 28th Annual Global Investment ConferenceGlobeNewswireDURHAM, N.C., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale,
- 2mo agoHUMAHumacyte Announces FDA Authorization Extending Symvess Shelf Life to 36 MonthsGlobeNewswire– FDA authorizes extension of Symvess expiration dating from 18 months to 36 months – – Extended shelf life supported by additional stability data demonstrating Symvess continues to meet all established quality
- 2mo agoHUMAHumacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA DiscussionsGlobeNewswire– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 – – Supplemental BLA will be supported by results from three Phase 3 studies of
- 2mo agoHUMAHumacyte Announces Lancet Digital Health Publication of V007 Phase 3 Hemodialysis Access Trial ResultsGlobeNewswire– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes – – Publication provides peer-reviewed validation for V007 Phase 3
- 2mo agoHUMABoard-Certified Vascular and Endovascular Surgeon Performs First Commercial Symvess® Implantation; Cites Bioengineered Blood Vessel as “Revolutionary Advancement”GlobeNewswire– Jeromy Brink, MD, Mayo Clinic–trained vascular surgeon in Phoenix, is the first surgeon in Arizona to implant Symvess, the first and only FDA-approved bioengineered human blood vessel – – Symvess is available
- 3mo agoHUMAHumacyte Second Quarter 2026 Earnings Conference Call - HUMACYTE INCEarnings Call TranscriptsGood morning, ladies and gentlemen, and welcome to HumanSafe's second quarter 2026 earnings conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. In
- 3mo agoHUMAHumacyte Second Quarter 2026 Earnings Conference Call - HUMACYTE INCEarnings Call TranscriptsGood morning, ladies and gentlemen, and welcome to HumanSafe's second quarter 2026 earnings conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. In
- 3mo agoHUMAHumacyte Announces Second Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswire– Breakthrough results from V012 dialysis access Phase 3 study, where ATEV was observed to outperform AV fistula; supplemental Biologic License Application (sBLA) for dialysis access to be filed with the Food and Drug
- 3mo agoHUMAHumacyte To Announce 2026 Second Quarter Financial Results and Provide Business Update on August 12, 2026GlobeNewswireDURHAM, N.C., Aug. 07, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale,
- 3mo agoHUMAHumacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass GraftingGlobeNewswire– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter – – Progression of CTEV into human study supported by positive preclinical results presented at multiple scientific
- 4mo agoHUMAHumacyte Appoints Key Nephrologists as Advisors to Prepare for Planned Commercialization of the ATEV in Dialysis AccessGlobeNewswire- Dr. Robert J. Kossmann has served as a prominent advocate for kidney disease patients in multiple roles including Executive Vice President and Chief Medical Officer for Fresenius Medical Care North America - - Dr.
- 4mo agoHUMAHumacyte's Bioengineered Blood Vessel Outperforms the Standard of Care for Women on Dialysis in Phase 3 Results Presented at the Society for Vascular Surgery Vascular Annual MeetingGlobeNewswire– Positive results from the V012 Phase 3 study were presented at the Society for Vascular Surgery's Vascular Annual Meeting in Boston – – Women who received Humacyte's ATEV experienced an average of three more
- 5mo agoHUMAHumacyte, Inc. Announces Pricing of Public Offering of Common StockGlobeNewswireDURHAM, N.C., June 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today
- 5mo agoHUMAHumacyte, Inc. Announces Proposed Public Offering of Common StockGlobeNewswireDURHAM, N.C., June 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today
- 5mo agoHUMAHumacyte ATEV Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in Female Dialysis Access PatientsGlobeNewswire- Humacyte plans to file a supplemental Biologic License Application (BLA) with the Food and Drug Administration (FDA) during the second half of 2026 - - The ATEV met V012's primary endpoint and was observed to have
- 5mo agoHUMAHumacyte Announces Presentation at VASA Meeting of Research Highlighting Self-Repair of ATEV After Cannulation for Dialysis AccessGlobeNewswire- Dialysis access requires frequent cannulation, often exceeding 300 needle punctures annually - - The ATEV was observed to maintain long-term structural integrity and self-repair with smooth muscle cell repopulation
- 5mo agoHUMAHumacyte Announces Symvess® is Now Under Contract with the Strategic Acquisition Center (SAC) of the U.S. Department of Veterans AffairsGlobeNewswire- Surgical Implant – Next Generation contract makes Symvess more easily accessible to 170 VA hospitals – - SAC awards require intensive product and value analysis vetting by a surgical committee and streamline the
- 6mo agoHUMAHumacyte Announces First Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswire- Appointed Jim Mercadante as Chief Commercial Officer and Dr. Todd Rasmussen as Chief Surgical Officer - - First quarter sales of Symvess® were $0.5 million in 2026 compared to $0.1 million in 2025 - -
- 6mo agoHUMAHumacyte Appoints Dr. Todd E. Rasmussen as Chief Surgical OfficerGlobeNewswire- Distinguished vascular surgeon brings decades of clinical experience, innovation, and leadership to new role at cutting-edge biotech manufacturer - - Appointment brings important surgical experience and perspective
- 6mo agoHUMAHumacyte To Announce 2026 First Quarter Financial Results and Provide Business Update on May 13, 2026GlobeNewswireDURHAM, N.C., May 08, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today
- 6mo agoHUMAHumacyte to Host Virtual KOL Event to Discuss ATEV for Arteriovenous (AV) Access for Hemodialysis Patients on April 28, 2026GlobeNewswireDURHAM, N.C., April 27, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale,
- 6mo agoHUMAHumacyte Expands Commercial and Business Development Opportunities Through Realignment of Ex-U.S. Rights to Symvess®GlobeNewswire- Ex-U.S. rights realigned under amendment to distribution agreement with Fresenius Medical Care - - Positions Humacyte to advance discussions with corporate partners regarding international and indication-specific
- 6mo agoHUMAHumacyte Appoints Jim Mercadante as Chief Commercial OfficerGlobeNewswire– Industry veteran with more than 25 years of experience will lead next phase of biotech company's commercial expansion – – Seasoned medtech commercial leader brings extensive field-specific success in vascular and
- 6mo agoHUMAHumacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess® for Vascular Trauma RepairGlobeNewswire- The Ministry of Health has set a 180-working-day review period for the MAA - - MAA process is one step in planned expansion of Symvess into multiple countries outside of the U.S - DURHAM, N.C., April 21, 2026
- 7mo agoHUMAHumacyte Announces Fourth Quarter and Year End 2025 Financial Results and Provides Business UpdateGlobeNewswire- Total revenues from sales and research collaborations were $0.5 million for fourth quarter and $2.0 million for full year - - Purchase commitment received for a minimum of $1.475 million for a clinical evaluation
- 7mo agoHUMAHumacyte Appoints Rick McElheny as Senior Vice President of Business DevelopmentGlobeNewswire- Mr. McElheney brings more than 15 of years' experience in corporate development and alliance management at biopharma companies. - - He will work with the Company's leadership team to expand corporate collaborations
- 7mo agoHUMAHumacyte To Announce 2025 Fourth Quarter and Year End Financial Results and Provide Business Update on March 27, 2026GlobeNewswireDURHAM, N.C., March 23, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale,
- 8mo agoHUMAHumacyte To Participate in Upcoming Investor ConferencesGlobeNewswireDURHAM, N.C., March 02, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale,
- 8mo agoHUMAHumacyte Announces Presentation of Symvess® Long-Term Safety and Efficacy Results at VESS MeetingGlobeNewswire- Data presented at Annual Winter Meeting 2026 for the Vascular & Endovascular Surgery Society - - After up to 36 months of follow-up, extremity arterial trauma patients had high rates of limb salvage, low rates of
- 9mo agoHUMAHumacyte Announces New U.S. Department of Defense Funding for Procurement of Bioengineered Blood VesselsGlobeNewswireDURHAM, N.C., Feb. 09, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today
- 10mo agoHUMAHumacyte Announces Hospital Charge Data Showing High Expense of Preventable Extremity Arterial Injury ComplicationsGlobeNewswire- Data is from comprehensive review of hospital charges and all-payer claims over five years - - Preventable complications such as amputation and conduit infection increased initial hospital charges by approximately
- 10mo agoHUMAHumacyte Announces Planned Marketing Authorization Application for Symvess® in IsraelGlobeNewswire- Expansion plans are based on requests for product access received from surgeons and hospitals in Israel - - Expansion of Symvess into other territories, including those in Europe and the Middle East, is also planned
- 10mo agoHUMAHumacyte Announces Publication of Long-Term Safety and Efficacy Results of Symvess® in Extremity Trauma RepairGlobeNewswire- Results published in Journal of Vascular Surgery Cases, Innovations and Techniques (JVS-CIT) - - After up to 36 months of follow-up, patients demonstrated high limb salvage, low rates of infection, no unprovoked
- 11mo agoHUMAHumacyte Announces Credit Facility of Up to $77.5 Million with Avenue CapitalGlobeNewswireDURHAM, N.C., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today
- 11mo agoHUMAHumacyte Announces Presentations at VEITHsymposium Highlighting Positive Acellular Tissue Engineered Vessel (ATEV™) Clinical ResultsGlobeNewswire– Post-implantation analysis of ATEVs demonstrates progressive recellularization with host cells, transforming the ATEV into a multi-layered living tissue similar to that of native blood vessels – – Positive outcomes
- 12mo agoHUMAHumacyte Announces Six Presentations Scheduled for the Upcoming 52nd Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITHsymposium)GlobeNewswireDURHAM, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today
- 12mo agoCRMDHUMAKBLBSLRXStrong Earnings and Biotech Resilience Define the Midweek MomentumGlobeNewswireDENVER, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Kraig Labs (OTCQB:KBLB) Spins the Future — Decades of Failure Give Way to a Commercial Breakthrough After decades of failed attempts by corporate giants and research
- 12mo agoHUMAHumacyte Announces Third Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswire- Total revenues of $753,000 for third quarter, and $1,571,000 for first nine months of 2025, from sales and collaborative research agreement - - Major advances in pipeline as Humacyte moves closer to planned BLA
- 1y agoHUMAHumacyte Announces Presentation of Positive Two-Year Results from Phase 3 Dialysis Access Trial at the American Society of Nephrology's Kidney Week 2025GlobeNewswire– The ATEV™ was observed to have superior duration of use over 24 months compared to autogenous fistula in high-need subgroups with historically poor outcomes with AV fistula procedures – – The significantly
- 1y agoHUMAHumacyte to Present Third Quarter Financial Results and Provide Business Update on November 12, 2025GlobeNewswireDURHAM, N.C., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will