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Humacyte (HUMA) Up on HAV BLA Priority Tag for Vascular Trauma
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Humacyte, Inc. (HUMA - Free Report) , a clinical-stage company, announced that the FDA has accepted the biologics license application (BLA) for its proprietary 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 in Ukraine under a Humanitarian Aid Program supported by the FDA. The HAV had higher rates of patency (blood flow) and lower rates of amputation and infection compared with historic synthetic graft benchmarks.
The HAV is being developed as a universally implantable vascular replacement that does not require immune suppression and resists infection after implantation.
The off-the-shelf nature of the candidate is expected to have several benefits over the current standard-of-care treatment, which has the potential to save valuable time for surgeons who treat injured patients and reduce complications, thereby improving outcomes.
Besides vascular trauma repair, the company is also currently evaluating the HAV in late-stage clinical studies for multiple other indications, including arteriovenous access for hemodialysis and peripheral artery disease.
However, it is important to note that the HAV is yet to be approved for sale by the FDA or any other regulatory agency.
Humacyte currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Puma Biotechnology, Inc. (PBYI - Free Report) , ImmunoGen and Immunocore (IMCR - Free Report) . While PBYI and IMGN currently sport a Zacks Rank #1 (Strong Buy) each, IMCR carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained constant at 69 cents. Over the past year, shares of PBYI have gained 33.2%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 EPS has remained constant at 7 cents. During the same period, the consensus estimate for ImmunoGen’s 2024 EPS has remained constant at 37 cents. Over the past year, shares of IMGN have skyrocketed 617.9%.
IMGN beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 136.05%.
In the past 30 days, the Zacks Consensus Estimate for Immunocore’s 2023 loss per share has remained constant at 95 cents. During the same period, the consensus estimate for Immunocore’s 2024 loss per share has remained constant at $1.42. Over the past year, shares of IMCR have jumped 13.5%.
IMCR beat estimates in two of the trailing four quarters and missed on the other two occasions. In the last reported quarter, IMCR reported an earnings surprise of 112.5%.
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Humacyte (HUMA) Up on HAV BLA Priority Tag for Vascular Trauma
Humacyte, Inc. (HUMA - Free Report) , a clinical-stage company, announced that the FDA has accepted the biologics license application (BLA) for its proprietary 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 in Ukraine under a Humanitarian Aid Program supported by the FDA. The HAV had higher rates of patency (blood flow) and lower rates of amputation and infection compared with historic synthetic graft benchmarks.
The HAV is being developed as a universally implantable vascular replacement that does not require immune suppression and resists infection after implantation.
The off-the-shelf nature of the candidate is expected to have several benefits over the current standard-of-care treatment, which has the potential to save valuable time for surgeons who treat injured patients and reduce complications, thereby improving outcomes.
Besides vascular trauma repair, the company is also currently evaluating the HAV in late-stage clinical studies for multiple other indications, including arteriovenous access for hemodialysis and peripheral artery disease.
However, it is important to note that the HAV is yet to be approved for sale by the FDA or any other regulatory agency.
Humacyte, Inc. Price and Consensus
Humacyte, Inc. price-consensus-chart | Humacyte, Inc. Quote
Zacks Rank and Stocks to Consider
Humacyte currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Puma Biotechnology, Inc. (PBYI - Free Report) , ImmunoGen and Immunocore (IMCR - Free Report) . While PBYI and IMGN currently sport a Zacks Rank #1 (Strong Buy) each, IMCR carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained constant at 69 cents. Over the past year, shares of PBYI have gained 33.2%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 EPS has remained constant at 7 cents. During the same period, the consensus estimate for ImmunoGen’s 2024 EPS has remained constant at 37 cents. Over the past year, shares of IMGN have skyrocketed 617.9%.
IMGN beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 136.05%.
In the past 30 days, the Zacks Consensus Estimate for Immunocore’s 2023 loss per share has remained constant at 95 cents. During the same period, the consensus estimate for Immunocore’s 2024 loss per share has remained constant at $1.42. Over the past year, shares of IMCR have jumped 13.5%.
IMCR beat estimates in two of the trailing four quarters and missed on the other two occasions. In the last reported quarter, IMCR reported an earnings surprise of 112.5%.