Humacyte Announces FDA Communication of Additional Time Required to Complete Review of acellular tissue engineered vessel (ATEV™) BLA for the Treatment of Vascular Trauma
August 09, 2024 16:05 ET
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Humacyte, Inc
– 2nd quarter conference call to be held Tuesday, August 13th, at 8:30 a.m. ET – DURHAM, N.C., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...
Humacyte Acellular Tissue Engineered Vessel (ATEV™) Meets Primary Endpoints in V007 Phase 3 Clinical Trial in Arteriovenous Access for Hemodialysis
July 31, 2024 07:00 ET
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Humacyte, Inc
– ATEV demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis – – Detailed results to be presented at...
Humacyte Board of Directors Strengthened with Addition of John P. Bamforth and Keith Anthony Jones
July 16, 2024 08:00 ET
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Humacyte, Inc
DURHAM, N.C., July 16, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at...
Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD)
July 01, 2024 08:00 ET
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Humacyte, Inc
– Third RMAT designation by FDA for ATEV – – RMAT will expedite development of ATEV in PAD – DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...
Humacyte Presents Positive Preclinical Data For Its BioVascular Pancreas (BVP™) Program
June 25, 2024 08:00 ET
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Humacyte, Inc
– 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...
Centers for Medicare & Medicaid Services (CMS) Issues ICD-10-PCS Codes for Humacyte’s Human Acellular Vessel™ (HAV™)
June 17, 2024 08:00 ET
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Humacyte, Inc
– Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte’s HAV – – BLA submission under Priority Review by FDA for...
Humacyte to Present at the Jefferies Global Healthcare Conference
May 30, 2024 08:00 ET
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Humacyte, Inc
DURHAM, N.C., May 30, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at...
Humacyte to Participate at Upcoming Investor Conferences in May
May 13, 2024 08:00 ET
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Humacyte, Inc
DURHAM, N.C., May 13, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at...
Humacyte First Quarter 2024 Financial Results and Business Update
May 10, 2024 07:00 ET
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Humacyte, Inc
-Biologics License Application (BLA) for HAV™ Accepted by FDA- -BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024- -Raised approximately $43...
Humacyte to Present First Quarter Financial Results and Provide Corporate Update on May 10, 2024
May 06, 2024 08:00 ET
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Humacyte, Inc
DURHAM, N.C., May 06, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at...