By David Bautz, PhD

NASDAQ:ABEO

READ THE FULL ABEO RESEARCH REPORT

Business Update

Zevaskyn™ Approved by FDA

On April 29, 2025, Abeona Therapeutics, Inc. (NASDAQ:ABEO) announced that the U.S. Food and Drug Administration (FDA) has approved Zevaskyn (prademagene zamikeracel) for the treatment of wounds in adults and children with recessive dystrophic epidermolysis bullosa (RDEB). The company indicated that the commercial launch will commence in the third quarter of 2025. Zevaskyn will have a wholesale acquisition cost (WAC) of $3.1 million, which is significantly more than what we had been modeling ($1.2 million). Management guided that between 10-14 patients are expected to be treated, and revenue recognized from those treatments, this year. Manufacturing capacity is expected to be able to handle up to six treatments per month by the end of 2025 and up to 10 treatments per month by mid-2026. The company reiterated that the total addressable market for Zevaskyn is approximately 750 patients in the U.S., with an estimated two procedures necessary for patients to cover most of their wounds. At the proposed WAC this represents a >$4 billion market opportunity.

During the conference call discussing Zevaskyn’s approval, management emphasized the therapy’s comprehensive value, not only for patients and caregivers but for the broader healthcare system as well. The burden of caring for individuals with RDEB is substantial: patients and caregivers often spend up to four hours daily on wound dressing changes, and the estimated monthly retail cost of specialized wound care can reach $80,000 (debra of America). Given that Zevaskyn has been shown to effectively treat chronic wounds, its adoption could yield a significant positive impact from both a clinical and health economic perspective.

In support of the company’s confidence in Zevaskyn’s potential, Abeona will be working with payers on outcomes-based agreements, which will include a partial reimbursement to the payer if a patient requires re-treatment of a previously treated wound within a three-year period.

In preparation for the commercial launch, the company is continuing negotiations with five Qualified Treatment Centers (QTCs), with the goal being to have these five QTCs come on-line over the next few months. These QTCs are geographically dispersed and each is a major treatment center for RDEB patients. The names of the QTCs will be announced upon their activation.

Abeona was also awarded a Priority Review Voucher (PRV) by the FDA. PRVs are fully transferrable and the past few of them have sold for approximately $150 million. We anticipate Abeona monetizing the PRV for a similar amount (~$150M), which will provide a substantial amount of non-dilutive capital.

Conclusion

We’re excited to see the approval of Zevaskyn and are very confident in management’s ability to conduct a successful commercial launch. Given the higher WAC than we had anticipated, we have adjusted our model to better reflect the drug’s commercial potential and have increased our near-term revenue estimates. In addition, we have increased the expected price of the PRV to be monetized. Following these changes, our valuation has increased to $11 per share. 

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