Abeona Therapeutics

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. » More on 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. » More on 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. » More on de.investing.com