Zevaskyn (pz-cel) by Abeona Therapeutics: status and timeline

Zevaskyn (pz-cel)

Close the large chronic wounds of recessive dystrophic epidermolysis bullosa for years with one surgery, by grafting the patient's own skin cells after fixing the gene that anchors skin layers together.

DeployStage 4 of 5

On sale; 12 patients treated by Aug 2026; Q2 2026 revenue $11.4M; manufacturing yield limits growth.

Updated 13 Aug 2026Checked 11 Oct0 updates this week

Milestones

Next · Expanding treatment centres and manufacturing yield

Phase 1/2a: grafted wounds stay closed over 5–6 yearsDoneComplete.
VIITAL phase 3: 81% of wounds half-healed vs 16% controlDoneComplete.
FDA approval29 Apr 2025Complete.
Medicare add-on payment (NTAP) takes effect1 Oct 2026Complete.
Expanding treatment centres and manufacturing yieldTarget 2026Current milestone.

Most important updates

Upcoming

2026Expanding treatment centres and manufacturing yield (next)

Current obstacles

Manufacturing yieldSome batches grow too few sheets or fail release tests; two treatments so far couldn't be billed.
Small, slow-growing marketRDEB is rare; uptake depends on activating specialist centres one at a time and on insurer coverage.

Physics limits

Treats patches, not the whole bodyGrafts fix only the skin they cover; blistering elsewhere, including the mouth and gut, continues because the gene is not corrected body-wide.
Living grafts are slow to makeEach batch is grown from one patient's cells over weeks, so cost, timing and failure rates can't scale like a vial-based drug.

How it works

4 parts

Biopsy

Take a little skin

A small skin biopsy supplies the patient's own keratinocytes, the cells of the skin's outer layer.

Gene fix

Add working collagen VII

The cells receive a corrected collagen VII gene; collagen VII forms the fibrils that anchor the top skin layer.

Sheets

Grow grafts in the lab

Corrected cells are grown into up to 12 sheets, each about the size of a credit card.

Graft

Cover the wounds once

Surgeons stitch sheets onto chronic wounds; patients keep them undisturbed 5–10 days while they take.

Spec sheet

Spec	Zevaskyn (pz-cel)
Wounds ≥50% healed at 6 months	81% vs 16% (standard care)^R (reported)
Grafts per treatment	Up to 12 credit-card-sized sheets^R (reported)
Patients treated since launch	12 (to Aug 2026)^R (reported)
Q2 2026 revenue	$11.4M^R (reported)
Longest follow-up (case report)	12 years^R (reported)

^R reported by the company

Update log

2 updates

Thu 13 Aug

Minor: Abeona: Zevaskyn revenue rises 31% to $11.4M in Q2 2026; 12 patients treated since launchPressCommercial

Tue 29 Apr 2025

Major: FDA approves Zevaskyn, the first cell-based gene therapy for wounds of recessive dystrophic epidermolysis bullosaPressRegulatory

About Abeona Therapeutics

The team behind Zevaskyn (pz-cel)

Abeona Therapeutics

Zevaskyn, gene-corrected skin grafts, butterfly skin

US company that makes Zevaskyn: sheets of a patient's own skin cells, gene-corrected to make collagen VII, grafted onto the chronic wounds of recessive dystrophic epidermolysis bullosa.

Zevaskyn approved by FDA April 2025, the first cell-based gene therapy for RDEB wounds.
Q2 2026 Zevaskyn revenue $11.4M (+31% QoQ); 12 patient treatments since launch.
Manufacturing yield is the bottleneck: two treatments so far could not be billed.

abeonatherapeutics.com (opens abeonatherapeutics.com)Company profile →

Headquarters: United States
Status: Public
Valuation: public
Works in: BiotechGene therapy
Coverage: 1 program · 2 updateslatest 13 Aug 2026checked 11 Oct
People: Vish SeshadriChief Executive Officer

Spec

Zevaskyn (pz-cel)

Wounds ≥50% healed at 6 months

81% vs 16% (standard care)^R (reported)

Grafts per treatment

Up to 12 credit-card-sized sheets^R (reported)

Patients treated since launch

12 (to Aug 2026)^R (reported)

Q2 2026 revenue

$11.4M^R (reported)

Longest follow-up (case report)

12 years^R (reported)