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MINNEAPOLIS - Bio-Techne Corporation (NASDAQ:TECH) announced Monday that its Simple Western technology played a supporting role in the FDA approval of ZEVASKYN, the first autologous cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB).
ZEVASKYN, developed by Abeona Therapeutics (NASDAQ:ABEO), a $293.64 million market cap biotech company with a "Fair" financial health score according to InvestingPro, treats a rare genetic skin disorder caused by mutations in the COL7A1 gene that leads to severe blistering, chronic wounds, and increased risk of complications.
According to the company’s press release, Bio-Techne’s technology was chosen for its ability to detect and quantify Collagen VII, a complex protein essential to the therapy’s potency. The platform provided data for lot release testing of both the viral vector and cell therapy components.
"The Simple Western platform was the best choice for our quality control laboratories due to the reproducibility, time-to-result, and GMP compliance of the platform," said Dr. Ann Durbin, Senior Director of Quality Control at Abeona Therapeutics.
Will Geist, Bio-Techne’s President of Protein Sciences Segment, called ZEVASKYN "a significant milestone for patients with RDEB and for the field of cell-based gene therapy."
The technology was selected over traditional western blot methods due to its speed, reproducibility, sensitivity, and minimal sample requirements, enabling detection of both trimeric and monomeric forms of Collagen VII despite analytical challenges posed by the protein’s structure.
Prior to this approval, treatment for RDEB had focused primarily on symptom management rather than addressing the underlying cause of the disease. With a strong current ratio of 4.9 and more cash than debt on its balance sheet, Abeona appears well-positioned to commercialize this breakthrough therapy. Analysts maintain a bullish outlook, with price targets ranging from $11 to $27.50 per share. For deeper insights into Abeona’s financial health and growth potential, access the comprehensive Pro Research Report available on InvestingPro.
In other recent news, Abeona Therapeutics Inc. has reported a significant development by completing the sale of its Rare Pediatric Disease Priority Review Voucher for $155 million, bolstering its financial position to approximately $225 million in cash and investments as of June 30, 2025. This sale is expected to provide the company with over two years of operating capital, supporting its strategic initiatives. Additionally, Abeona’s first-quarter 2025 earnings revealed a smaller-than-expected loss per share at -$0.24, surpassing the forecasted -$0.37, indicating effective cost management.
The company also announced a licensing agreement with Beacon Therapeutics for its AAV204 capsid, aimed at developing gene therapies for retinal diseases. This agreement allows Beacon to use the AAV204 capsid for up to five gene therapy targets, with Abeona receiving upfront and potential milestone payments. Analyst firms have been active, with Oppenheimer assuming coverage of Abeona with an Outperform rating, highlighting the approval of ZEVASKYN and its commercial potential. Meanwhile, Stifel adjusted its price target for Abeona to $20, maintaining a Buy rating, reflecting on recent financial outlooks.
Abeona’s progress in launching ZEVASKYN, a gene therapy for treating wounds in recessive dystrophic epidermolysis bullosa, is supported by agreements with major payer groups, enhancing its commercial trajectory. The company anticipates its first patient treatment in the third quarter of 2025 and projects profitability by early 2026. These developments underscore Abeona’s strategic advancements and financial health, providing a foundation for its future growth in the biopharmaceutical sector.
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