DURHAM, N.C. - Humacyte, Inc. (NASDAQ:HUMA), a biotechnology firm, announced it has been awarded a third Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for its bioengineered Acellular Tissue Engineered Vessel (ATEV), intended for patients with advanced peripheral artery disease (PAD).
This latest designation, which aims to expedite the development and review process for regenerative therapies for serious diseases, coincides with the FDA's clearance of a new Investigational New Drug (IND) application for ATEV in the PAD indication.
ATEV, previously known as the Human Acellular Vessel (HAV), is designed to be universally implantable and is currently in late-stage clinical trials for multiple vascular applications. The product has demonstrated a low infection rate in trials and is intended to be readily available for surgeons, which could potentially save time and improve patient outcomes for individuals without autologous vein available for bypass surgery.
PAD, a cardiovascular disease affecting leg arteries, leaves up to 40% of patients requiring lower leg bypass without suitable veins for the standard revascularization procedure. ATEV has been evaluated in two Phase 2 studies for PAD, with patient follow-ups lasting up to six years. Additionally, The Mayo Clinic is conducting a study on ATEV for chronic limb-threatening ischemia, the end stage of PAD.
Humacyte's ATEV has previously received RMAT designations for vascular trauma repair and arteriovenous access in hemodialysis. The FDA is currently reviewing a Biologics License Application for ATEV with a Priority Review, with an action date set for August 10, 2024.
The company, which focuses on developing universally implantable bioengineered human tissues and organs, has stated that this third RMAT designation will likely enhance their communication with the FDA and speed up the development process for ATEV in treating advanced PAD. However, it is important to note that ATEV is still an investigational product and has not yet been approved for sale by the FDA or any other regulatory agency.
This news is based on a press release statement from Humacyte, Inc.
In other recent news, Humacyte, a biotechnology company, has been showing significant advancements in its operations. The company reported a net loss of $31.9 million for the first quarter of 2024 but managed to secure $63 million in funding, ending the quarter with $115.5 million in cash and cash equivalents.
In addition, Humacyte received approval for four new ICD-10-PCS codes by the U.S. Centers for Medicare & Medicaid Services for procedures involving the replacement of arteries using the company's Human Acellular Vessels.
TD Cowen has maintained a Buy rating on Humacyte and raised its price target to $7.50 following the release of promising preclinical data. The data revealed Humacyte's stem cell-derived islets' success in restoring normal blood glucose levels in non-human primate models, suggesting potential for future medical applications.
The company also announced a reshuffle of its board of directors and the ratification of PricewaterhouseCoopers LLP as its independent auditor. These recent developments highlight Humacyte's ongoing efforts to commercialize its flagship product. The company is now awaiting a crucial FDA approval decision for its Human Acellular Vessel product, a milestone that could catalyze further interest in the company.
InvestingPro Insights
As Humacyte, Inc. (NASDAQ:HUMA) makes strides in the biotechnology arena with its Acellular Tissue Engineered Vessel (ATEV), investors and industry watchers are keeping a close eye on the company's financial health and stock performance. According to InvestingPro data, Humacyte holds a market capitalization of $571.6 million USD, signaling a strong investor interest in its innovative approach to regenerative medicine.
Despite the optimism surrounding the FDA's recent RMAT designation for ATEV, InvestingPro Tips indicate that Humacyte faces challenges, including weak gross profit margins, as evidenced by a gross profit of -$80.54 million USD in the last twelve months as of Q1 2024.
Moreover, the company's stock price has experienced significant volatility, with a 1-month price total return of -35.83%, yet demonstrated a robust 1-year price total return of 67.83%. This volatility underscores the market's sensitivity to both the company's advancements and the inherent risks in the biotech sector.
InvestingPro Tips also reveal that Humacyte is trading at a high Price / Book multiple of 21.86, which may suggest that the stock is valued richly relative to its book value. This could be a point of consideration for investors who weigh traditional valuation metrics heavily in their investment decisions. Analysts do not anticipate Humacyte will be profitable this year, adding another layer of caution for potential investors.
For those interested in a deeper dive into Humacyte's financials and stock performance, InvestingPro offers additional insights and tips. With the use of coupon code PRONEWS24, readers can receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these valuable resources. There are 11 more InvestingPro Tips available for Humacyte, which could provide further guidance for investors considering this company amidst its clinical and regulatory advancements.
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