Humacyte Announces Planned IND Filing in 2025 to Support First-In-Human Clinical Study of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting
Humacyte, Inc. (HUMA)
Company Research
Source: GlobeNewswire
– Plans for filing an IND was agreed with the FDA in a recent meeting – – Positive preclinical results of the small-diameter ATEV were recently presented at The American Heart Association’s Scientific Sessions 2024 meeting – DURHAM, N.C., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that it plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to allow first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG). The Company’s current plans for filing an IND are based on the outcome of a recent meeting held with the FDA, including agreements reached with the agency. To date only the 6.0mm configuration of the ATEV has been studied in human trials, specifically in studies conducted in vascu
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HUMA
News
- Humacyte (NASDAQ:HUMA) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=HUMA&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> fMarketBeat
- Humacyte (HUMA): Benchmark Remains Bullish on Stock [Yahoo! Finance]Yahoo! Finance
- Humacyte (NASDAQ:HUMA) had its "buy" rating reaffirmed by analysts at UBS Group AG.MarketBeat
- Humacyte (NASDAQ:HUMA) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- Humacyte (HUMA) Q3 2025 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
HUMA
Earnings
- 11/12/25 - Beat
HUMA
Sec Filings
- 12/15/25 - Form 8-K
- 12/15/25 - Form 8-K
- 12/15/25 - Form 424B3
- HUMA's page on the SEC website