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2 stories mentioning HUMAUpdated 11d ago

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Wire

Humacyte Says ATEV Met Late-Stage Study Endpoint in Interim Analysis, Launches Public Offering; Shares Fall

Humacyte (HUMA) said Wednesday that its bioengineered blood vessel, the acellular tissue engineered vessel, or ATEV, met the primary endpoint in a late-stage study of female patients requiring dialysis access.In the interim analysis of the study, the first 80 patients who received ATEV had an average of 91 more catheter-free days than patients who received the current standard of care, an autologous arteriovenous fistula, according to a statement.The company said it plans to file a supplemental biologic license application with the US Food and Drug Administration in the second half of the year.The biotechnology company has also launched a public offering of common stock to fund the commercialization of Symvess, the filing of a Biologics License Application supplement for a hemodialysis indication, and the development of product candidates in its pipeline.Underwriters are expected to have a 30-day option to buy up to an additional 15% of the shares offered, it said.Shares of the company fell over 11% in after-hours trading.

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Wire

Humacyte Says Israeli Health Ministry Accepts Marketing Authorization Application for Symvess

Humacyte (HUMA) said Tuesday its marketing authorization application for Symvess acellular tissue engineered vessel to be used for arterial trauma repair has been accepted by Israel's Ministry of Health.The company said the ministry has set a 180-working-day review period.

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