Humacyte (HUMA) Up on HAV BLA Priority Tag for Vascular Trauma [Yahoo! Finance]
Humacyte, Inc. (HUMA)
Company Research
Source: Yahoo! Finance
bioengineered tissue, Human Acellular Vessel (HAV), to treat vascular trauma, under Priority Review. A filing designated as a Priority Review reduces the review period by four months. A final decision from the regulatory body is expected on Aug 10, 2024. The BLA is seeking approval for the HAV in urgent arterial repair following extremity vascular trauma when the synthetic graft is not indicated and autologous vein use is not feasible. We remind the investors that in May 2023, the FDA granted the Regenerative Medicine Advanced Therapy designation to the HAV for the same indication. Humacyte's stock gained 15.7% in the last trading session as the investors cheered the encouraging regulatory update. In the past year, shares of HUMA have jumped 20.6% against the industry's 12.1% decline. Image Source: Zacks Investment Research The BLA is based on positive results from the phase II/III V005 clinical study of the HAV, along with real-world evidence from treating wartime injuries
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News
- Artificial Pancreas Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies 2024 [Yahoo! Finance]Yahoo! Finance
- Humacyte, Inc. (NASDAQ: HUMA) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $7.00 price target on the stock.MarketBeat
- Humacyte to Host Virtual KOL Event “Hemodialysis Access: A Crossroads of Care,” on March 28, 2024GlobeNewswire
- Humacyte, Inc. (NASDAQ: HUMA) had its "neutral" rating re-affirmed by analysts at Piper Sandler. They now have a $4.00 price target on the stock.MarketBeat
- Humacyte, Inc. (NASDAQ: HUMA) had its "buy" rating re-affirmed by analysts at Benchmark Co.. They now have a $15.00 price target on the stock.MarketBeat
HUMA
Earnings
- 3/22/24 - Beat
HUMA
Sec Filings
- 3/28/24 - Form S-8
- 3/28/24 - Form 10-K
- 3/22/24 - Form 8-K
- HUMA's page on the SEC website