Humacyte, Inc. HUMA announced a delay in the FDA’s review of its Biologic License Application (BLA) for its Acellular Tissue Engineered Vessel (ATEV). The FDA, which had granted a Priority Review to this pioneering vascular trauma treatment, now requires additional time beyond the original Prescription Drug User Fee Act (PDUFA) date of Aug 10, 2024, to complete its evaluation. Despite the delay, Humacyte remains confident about ATEV’s potential approval and its transformative role in trauma care.
Humacyte's leading product candidates include a portfolio of ATEVs, currently in late-stage clinical trials for various vascular applications such as trauma repair, arteriovenous (AV) access for hemodialysis and peripheral artery disease. Humacyte is also advancing preclinical development in areas like coronary artery bypass grafts, pediatric heart surgery and treatments for type 1 diabetes. The company’s 6mm ATEV for AV access in hemodialysis was the first to receive the FDA’s Regenerative Medicine Advanced Therapy designation, alongside Fast Track designation, highlighting its potential to revolutionize treatment options.
The FDA is yet to give a revised date for the completion of the review.
Significance of ATEV
Per Humacyte, ATEV is one of its key candidates to revolutionize vascular trauma treatment. As a first-in-class bioengineered tissue, ATEV demonstrates Humacyte’s cutting-edge approach to developing universally implantable products that address critical medical needs.
By providing an off-the-shelf solution for arterial replacement and repair, ATEV minimizes the need for vein harvesting, reducing surgical complexity and patient risk. The positive outcomes from clinical trials and real-world applications, especially in high-stress environments like war zones, highlight ATEV's potential in both civilian and military trauma care. This product not only showcases Humacyte’s innovative capabilities but also underscores its commitment to advancing life-saving medical technologies on a global scale.
More on the News
Humacyte's BLA for ATEV is seeking approval for treating vascular trauma. The BLA includes data from the pivotal Phase 2/3 V005 clinical study, along with real-world evidence from its use in treating wartime injuries in Ukraine, which showed promising results. ATEV has been effectively used to repair a wide range of traumatic injuries, including those from car accidents, gunshot wounds, blast injuries and industrial accidents.
In clinical settings, ATEV was utilized by vascular and trauma surgeons at Level 1 trauma centers across the United States and Israel, as well as in front-line hospitals in Ukraine. The product demonstrated high rates of patency (maintained blood flow) and was associated with low rates of amputation and infection, making it a potentially life-saving option for severe limb-threatening and life-threatening injuries.
The FDA granted ATEV Priority Review, which shortens the review cycle to six months compared to the standard 10 months. Despite the FDA’s need for additional time to complete its review, Humacyte remains confident about the product’s approval based on positive interactions with the FDA, including inspections of manufacturing facilities and clinical sites, as well as discussions on post-marketing and labeling requirements.
Industry Prospects
Per a report in Valuates Reports, the global vascular injury treatment market was worth $2.5 billion in 2023. It is anticipated to reach $3.24 billion by 2030 at a CAGR of 3.4%.
The robust growth will be primarily driven by the rising prevalence of chronic diseases, which often require complex vascular interventions. Additionally, increased funding from both private and government organizations supports the development and expansion of pharmaceutical manufacturing, bolstering the vascular treatment segment. Ongoing research and development activities are also crucial as they lead to the discovery of new and improved therapies, keeping the industry innovative and competitive.
Price Performance
Humacyte’s shares fell over 19% following the news of the FDA’s delay in the review of its BLA for ATEV. Shares of Humacyte have increased 19.4% so far this year against an 18.9% fall of the industry. The S&P 500 has witnessed a 26.8% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Humacyte carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the broader medical space are Universal Health Service UHS, Quest Diagnostics DGX and ABM Industries ABM. While Universal Health Service sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Service has gained 41.1% compared with the industry's 34.8% rise so far this year.
Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.
Quest Diagnostics shares have gained 3.7% so far this year compared with the industry’s 10.2% rise.
ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.
ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% increase.
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