Abeona Therapeutics: Advancing UX111 Toward First-to-Market Approval and Scaling ZEVASKYN Launch to Near-Term Profitability

Analyst Ram Selvaraju of H.C. Wainwright reiterated a Buy rating on Abeona Therapeutics, retaining the price target of $20.00.

Ram Selvaraju has given his Buy rating due to a combination of factors tied to both clinical and commercial momentum at Abeona Therapeutics. He highlights the on-time resubmission of the Biologics License Application for UX111 by licensee Ultragenyx, now supported by extended follow-up data showing sustained neurological benefits, biomarker improvements, and an acceptable safety profile in Sanfilippo syndrome type A patients. The resubmission comprehensively addresses prior FDA chemistry, manufacturing, and controls issues and incorporates additional long-term clinical data requested in the earlier Complete Response Letter, which strengthens the overall regulatory package ahead of an anticipated 3Q26 approval decision. Selvaraju also notes that if approved, UX111 would be the first treatment for this disease, positioning Abeona to benefit from tiered royalties and milestone payments that are not yet reflected in his current valuation, thereby representing potential upside.

At the same time, Selvaraju underscores attractive commercial fundamentals around Abeona’s lead product ZEVASKYN, including a focused launch strategy through a limited number of qualified treatment centers in the U.S. that should optimize operational efficiency. He projects that as these centers ramp up to treating approximately 10–12 patients per month in aggregate, the company could reach a revenue level sufficient to generate sustainable positive cash flow. Based on these dynamics, he believes Abeona is on track to achieve profitability potentially before year-end, supporting his reiterated Buy rating and 12‑month price target of $20.