Abeona Therapeutics

Abeona has commercially launched ZEVASKYN, has treated roughly a dozen patients to date and operates seven qualified treatment centers. The rollout is deliberately slow because logistics, production bottlenecks and reimbursement processes limit patient access; current production capacity is six treatments per month with a target of ten by 2027. ZEVASKYN is priced at $3.1 million per cycle and achieves cost coverage for more than 95% of commercially insured patients, as well as basic Medicaid coverage across all 51 jurisdictions. Abeona views 2026/early 2027 as a build-up phase and sees additional value potential from partner programs and its pipeline, including a CER-T program against prostate cancer. » Mere på de.investing.com

Abeona reported Q2 revenue of $11.4 million driven by its ZEVASKYN cell therapy and has treated 12 patients since launch while expanding to seven activated treatment sites. The company secured a Medicare NTAP technology add-on payment for FY2027, improving reimbursement prospects, but faced manufacturing low-yield and out-of-spec batches, an 84-hour shelf-life scheduling constraint and last-minute biopsy cancellations. Net loss widened to $20.2 million, R&D and SG&A declined, and cash and short-term investments stood at $146.8 million as Abeona shifts disclosures to focus on treated patients and recognized revenue. » Mere på finance.yahoo.com

Abeona Therapeutics missed second-quarter revenue expectations and reported a loss of $0.35 per share versus a profit of $1.71 a year earlier. Revenue was $11.4 million versus an expected $12.2 million after a production batch failed to reach the required minimum number of units, so revenue could be recognized for only four of five treated patients. The stock fell 15.8% in premarket trading; investors are now worried about the commercial scalability of ZEVASKYN. CEO Vish Seshadri stressed progress in the product launch and growing patient interest, while earlier insider sales have heightened market caution. » Mere på de.investing.com

Abeona Therapeutics has approved Cincinnati Children’s as the seventh qualified center to administer ZEVASKYN. ZEVASKYN (Prademagene Zamikeracel) is an autologous, gene-modified cell therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) and delivers the functional COL7A1 gene via a replication-incompetent retroviral vector. Abeona operates a manufacturing site in Cleveland for the commercial production of ZEVASKYN and offers patient support through the “Abeona Assist” program. » Mere på de.investing.com

Abeona Therapeutics has appointed Keith A. Goldan to its board as an independent member effective April 1; he will chair the audit committee. Goldan brings more than 20 years of financial leadership in publicly traded biotech and pharma companies, currently serving as CFO of Syndax Pharmaceuticals, and previously held CFO roles at several specialty firms as well as senior finance positions at KPMG and ViroPharma. Abeona is a commercial biopharma company with the product ZEVASKYN for treating wounds in recessive dystrophic epidermolysis bullosa; according to the report the company has a strong balance sheet and analysts’ estimates of roughly 10% revenue growth for the year. » Mere på de.investing.com