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Regulatory

FDA Needs More Time to Review Humacyte’s Blood Vessel Implant

Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.

August 12, 2024

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1 min read

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Tristan Manalac

Bio NC

Humacyte to Participate at Upcoming Investor Conferences in May

Humacyte, Inc. today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, Dale Sander, Chief Financial Officer, and B.J. Scheessele, Chief Commercial Officer, will represent Humacyte at the following conferences in May.

May 13, 2024

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2 min read

Bio NC

Humacyte to Present at the Jefferies Global Healthcare Conference

Humacyte, Inc. today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference, in New York, NY on Thursday, June 6, 2024.

May 30, 2024

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2 min read

Bio NC

Centers for Medicare & Medicaid Services (CMS) Issues ICD-10-PCS Codes for Humacyte’s Human Acellular Vessel™ (HAV™)

Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable, Human Acellular Vessels at commercial scale, announced the issuance of four new ICD-10-PCS codes by the U.S. Centers for Medicare & Medicaid Services ICD-10 Coordination and Maintenance Committee.

June 17, 2024

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7 min read

Press Releases

Humacyte Announces Pricing of $30.0 Million Registered Direct Offering

October 4, 2024

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6 min read

Drug Development

Humacyte Presents Positive Preclinical Data For Its BioVascular Pancreas (BVP™) Program

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced the presentation of positive preclinical progress of its development of a potential treatment for type 1 diabetes at two scientific meetings.

June 25, 2024

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6 min read

Press Releases

Humacyte to Participate at Upcoming Investor Conferences in September 2024

September 4, 2024

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2 min read

Business

Humacyte First Quarter 2024 Financial Results and Business Update

Humacyte, Inc. announced financial results for the first quarter ended March 31, 2024 and highlighted recent accomplishments advancing the investigational Human Acellular Vessel™ closer to planned U.S. market launch.

May 10, 2024

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14 min read

Press Releases

Humacyte Announces Allowance of U.S. Patent Covering BioVascular Pancreas (BVP™)

September 19, 2024

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7 min read

Press Releases

Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD)

Humacyte, Inc. has been granted the U.S. Food and Drug Administration’s (FDA’s) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD).

July 1, 2024

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6 min read