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Humacyte (HUMA) FDA Events

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FDA Events for Humacyte (HUMA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Humacyte (HUMA). Over the past two years, Humacyte has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ATEV™, Human, and V007. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Humacyte's Drugs in FDA Review

ATEV™ - FDA Regulatory Timeline and Events

ATEV™ is a drug developed by Humacyte for the following indication: For the Treatment of Vascular Trauma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Human Acellular Vessel - FDA Regulatory Timeline and Events

Human Acellular Vessel is a drug developed by Humacyte for the following indication: Coronary Artery Bypass Grafting. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

V007 - FDA Regulatory Timeline and Events

V007 is a drug developed by Humacyte for the following indication: For patients with end-stage renal disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Humacyte FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Humacyte (HUMA) has reported FDA regulatory activity for the following drugs: V007, ATEV™ and Human Acellular Vessel.

The most recent FDA-related event for Humacyte occurred on June 9, 2025, involving V007. The update was categorized as "Results," with the company reporting: "Humacyte, Inc. announced that the results from its V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients at high risk of autologous arteriovenous fistula (AVF) maturation failure with end-stage renal disease were presented in a plenary session at the Society for Vascular Surgery Vascular Annual Meeting (VAM25), held in New Orleans, LA, on June 6, 2025."

Current therapies from Humacyte in review with the FDA target conditions such as:

  • For patients with end-stage renal disease. - V007
  • For the Treatment of Vascular Trauma - ATEV™
  • Coronary Artery Bypass Grafting - Human Acellular Vessel

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:HUMA) was last updated on 7/10/2025 by MarketBeat.com Staff
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