Abeona Therapeutics Inc.
- Open
- 5.91
- Day high
- 5.91
- Day low
- 5.78
- Prev close
- 5.92
- Volume
- 987K
- Mkt cap
- $335M
- P/E (TTM)
- —
- EPS (TTM)
- —
- P/B
- 2.6
- P/S
- 13.1
- Yield
- —
- Per share
- —
- ▼Insiders net selling -$1.7M over the last 3 months (0 open-market buys, 16 sales)
Abeona Therapeutics Inc. (ABEO) is a Healthcare company listed on NASDAQ. The stock is down 15% over the past year. Over the trailing 3 months, insiders filed 0 open-market buys and 16 sales (SEC Form 4).
Abeona Therapeutics Inc. (ABEO) financials & analyst ratings
Fundamentals (TTM)
Analyst consensus · 2 analysts
Source: exchange market data + company filings. Figures are trailing-twelve-month or as most recently reported. For informational purposes only — not investment advice.
ABEO earnings date, history & EPS estimates
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| Aug 13, 2026 | $-0.23 | $-0.35 | -51.1% | $11M | -7.0% |
| May 13, 2026 | $-0.33 | $-0.30 | +9.1% | $9M | +90.7% |
| Mar 17, 2026 | $-0.35 | $-0.34 | +3.4% | $5M | -33.9% |
| Nov 12, 2025 | $-0.27 | $-0.10 | +63.0% | — | — |
| Aug 14, 2025 | $-0.39 | $1.71 | +538.5% | $400000 | -93.9% |
| May 15, 2025 | $-0.35 | $-0.24 | +31.4% | — | — |
| Mar 20, 2025 | $-0.43 | $-0.24 | +44.2% | — | — |
| Nov 14, 2024 | $-0.38 | $-0.31 | +18.4% | — | — |
| May 15, 2024 | $-0.47 | $-0.53 | -12.8% | — | — |
| Mar 18, 2024 | $-0.51 | $-0.64 | -25.5% | $3M | — |
| Nov 13, 2023 | $-0.53 | $-0.48 | +9.4% | — | — |
| May 11, 2023 | $-0.58 | $-0.54 | +6.9% | — | — |
ABEO insider trading activity (SEC Form 4)
| Date | Insider | Type | Shares | Price |
|---|---|---|---|---|
| Jul 22, 2026 | Vazzano Joseph Walterofficer: Chief Financial Officer | Sell | 1,478 | $6.53 |
| Jul 9, 2026 | Vasanthavada Madhavofficer: Chief Commercial Officer | Sell | 12,606 | $6.96 |
| Jul 9, 2026 | O'Malley Brendan M.officer: SVP, Chief Legal Officer | Sell | 12,050 | $6.96 |
| Jul 9, 2026 | Seshadri Vishwasdirector, officer: Chief Executive Officer | Sell | 67,971 | $6.96 |
| Jul 9, 2026 | Vazzano Joseph Walterofficer: Chief Financial Officer | Sell | 24,880 | $6.96 |
| Jul 2, 2026 | Alland Leiladirector | Sell | 11,000 | $5.92 |
| Jun 15, 2026 | Silverstein Christine Bernidirector | Sell | 18,160 | $5.71 |
| Jun 9, 2026 | Vasanthavada Madhavofficer: Chief Commercial Officer | Sell | 5,450 | $5.30 |
| Jun 9, 2026 | Vazzano Joseph Walterofficer: Chief Financial Officer | Sell | 25,646 | $5.39 |
| Jun 9, 2026 | Seshadri Vishwasdirector, officer: Chief Executive Officer | Sell | 24,428 | $5.43 |
| Jun 9, 2026 | O'Malley Brendan M.officer: SVP, Chief Legal Officer | Sell | 6,305 | $5.30 |
| Jun 9, 2026 | Vazzano Joseph Walterofficer: Chief Financial Officer | Sell | 13,421 | $5.30 |
| Jun 9, 2026 | Seshadri Vishwasdirector, officer: Chief Executive Officer | Sell | 31,916 | $5.30 |
| Jun 9, 2026 | Vazzano Joseph Walterofficer: Chief Financial Officer | Sell | 10,271 | $5.43 |
| Jun 9, 2026 | O'Malley Brendan M.officer: SVP, Chief Legal Officer | Sell | 4,826 | $5.43 |
Source: ABEO SEC Form 4 filings, latest Jul 22, 2026. For informational purposes only — not investment advice.
See the full ABEO insider & 13F page →Abeona Therapeutics Inc. company profile
Overview
Abeona Therapeutics Inc. (NASDAQ:ABEO) is a clinical-stage biopharmaceutical company founded in 1974 and headquartered in New York, New York. Originally incorporated as PlasmaTech Biopharmaceuticals, the company changed its name to Abeona Therapeutics in June 2015. The company specializes in developing gene and cell therapies for life-threatening rare genetic diseases. In April 2025, Abeona achieved a major milestone with the FDA approval of ZEVASKYN, marking the first autologous cell-based gene therapy approved for treating Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder.
Business
Abeona Therapeutics operates in the biotechnology sector, specifically focusing on gene and cell therapy development for rare genetic diseases. The company's primary approach involves using advanced genetic engineering techniques to correct defective genes that cause devastating inherited disorders. The company's flagship product is ZEVASKYN (formerly known as EB-101 or pz-cel), an autologous gene-corrected cell therapy for RDEB. RDEB is a rare genetic condition where patients lack functional collagen VII protein, resulting in extremely fragile skin that blisters and tears with minimal contact. ZEVASKYN works by taking a patient's own skin cells, genetically correcting the defective COL7A1 gene in a laboratory setting, and then growing these corrected cells into skin sheets that are transplanted back onto the patient's chronic wounds. This approach essentially provides the patient with their own genetically-corrected skin that can produce the missing collagen VII protein. Beyond ZEVASKYN, Abeona's pipeline includes several other gene therapy programs targeting different rare diseases: 1. ABO-102 - An adeno-associated virus (AAV)-based gene therapy for Sanfilippo syndrome type A, a rare lysosomal storage disorder that causes progressive neurodegeneration in children. 2. ABO-201 - A treatment for CLN3 disease, another rare neurodegenerative disorder affecting children. 3. ABO-401 - A gene therapy approach for cystic fibrosis, a genetic disorder affecting the lungs and digestive system. 4. Ophthalmology programs - Including treatments for genetic eye disorders such as Stargardt disease, X-linked retinoschisis, and autosomal dominant optic atrophy, with clinical trials expected to begin in the second half of 2026. The company also develops therapies through its AIM vector platform, which focuses on creating improved AAV-based delivery systems for gene therapies. Currently, ZEVASKYN represents virtually 100% of the company's immediate revenue opportunity, as other programs remain in preclinical or early clinical development stages.
Revenue model
Abeona Therapeutics operates on a product sales business model, generating revenue through the commercialization of approved gene and cell therapies. With ZEVASKYN's recent FDA approval, the company is transitioning from a pure research and development entity to a commercial-stage biopharmaceutical company. The primary revenue stream comes from selling ZEVASKYN treatments to hospitals and specialized treatment centers. Each treatment is highly personalized, requiring the company to take a patient's skin biopsy, genetically correct the cells in their manufacturing facility, grow the cells into therapeutic skin sheets, and deliver the final product back to the treating physician for transplantation. This complex manufacturing process commands premium pricing, with the company targeting a potential cumulative revenue opportunity of over $2 billion in the U.S. market alone, based on an estimated 750 RDEB patients nationwide. The paying customers are primarily hospitals and specialized Epidermolysis Bullosa (EB) treatment centers, which then bill insurance providers. The company has developed market access strategies targeting different payer segments: approximately 60-65% of RDEB patients are covered by commercial insurance plans, 30-35% by Medicaid programs, and less than 10% by Medicare. Abeona has executed outcomes-based agreements with payer contracting organizations and is actively engaging with commercial payers to secure coverage. Several factors could significantly impact Abeona's margins and profitability. Positive margin drivers include the company's manufacturing scale-up from the current capacity of 4 patients per month to a targeted 8-10 patients per month by early 2026, which should improve operational efficiency. The company's Priority Review Voucher, valued at approximately $155 million and pending sale, provides substantial non-operating income. Additionally, the limited competition in the RDEB treatment space and the life-threatening nature of the condition support premium pricing power. Conversely, margin pressures could arise from the complex and labor-intensive manufacturing process, which requires specialized facilities and highly trained personnel. Payer negotiations and the need to demonstrate long-term treatment outcomes could pressure pricing. The company also faces ongoing research and development costs for its pipeline programs, and the small patient population limits the total addressable market size, requiring efficient patient identification and treatment center scaling to achieve profitability.
Competitive moat
Abeona Therapeutics possesses a moderate but meaningful competitive moat in the RDEB treatment space, primarily built around regulatory exclusivity, manufacturing complexity, and specialized expertise. The company's strongest defensive position comes from being the first and currently only FDA-approved autologous gene-corrected cell therapy for RDEB, providing significant first-mover advantages in a rare disease market with high unmet medical need. The technical complexity of Abeona's manufacturing process creates substantial barriers to entry. The company's approach requires sophisticated capabilities in gene editing, cell culture, tissue engineering, and specialized manufacturing facilities that comply with stringent FDA regulations. This manufacturing expertise, combined with the company's established relationships with EB treatment centers and patient advocacy groups, creates operational advantages that would be difficult for competitors to replicate quickly. However, the moat faces several potential challenges. The rare disease space attracts significant competition from both established pharmaceutical companies and emerging biotechnology firms with substantial resources. Companies like Castle Creek Biosciences (which developed VYJUVEK, another RDEB treatment) and Krystal Biotech (with FILSUVEZ) have already demonstrated that alternative approaches to treating RDEB can gain regulatory approval and market acceptance. These existing competitors prove that Abeona's moat is not insurmountable. The company's intellectual property position, while important, may not provide indefinite protection as patents eventually expire and competitors develop alternative approaches to gene correction or cell therapy delivery. Additionally, the small patient population (approximately 750 in the U.S.) means that market share battles could be particularly intense, and any new entrant with a simpler, more cost-effective, or more efficacious treatment could quickly erode Abeona's position. The durability of Abeona's moat ultimately depends on execution - successfully scaling manufacturing, demonstrating superior long-term outcomes, maintaining strong payer relationships, and continuing to innovate in gene therapy approaches. While the current competitive position is favorable, the moat should be considered moderate rather than strong, requiring continuous investment and execution to maintain.
Risks & safety
Abeona Therapeutics presents a mixed margin of safety profile, with significant cash resources offset by ongoing losses and execution risks in a newly commercial business. **Cash Position and Solvency:** - Strong liquidity with $84.5 million in cash and equivalents as of March 31, 2025 - Additional $155 million expected from Priority Review Voucher sale, providing over two years of operating runway - Current ratio of 4.9x indicates strong short-term liquidity - Debt-to-equity ratio of 0.58x represents manageable leverage levels - Free cash flow burn of approximately $19.8 million quarterly, though this should improve with ZEVASKYN commercialization **Operational Burn and Profitability:** - Quarterly net losses of $12 million in Q1 2025, with negative EBITDA of $19.7 million - No current revenue generation, though commercial launch is underway - Manufacturing capacity constraints limit near-term revenue potential to 4-6 patients per month initially **Valuation Metrics:** - Trading at 5.7x price-to-book ratio, indicating premium valuation relative to tangible assets - Negative earnings metrics due to pre-profitability stage - Enterprise value reflects optimistic expectations for ZEVASKYN commercial success **Other Considerations:** - Single-product dependency creates concentration risk - Small addressable market limits total revenue potential - Regulatory and manufacturing execution risks in scaling commercial operations - Competition from existing RDEB treatments may impact market penetration
Recent development
Over the past few years, Abeona Therapeutics has undergone a significant strategic transformation from a diversified rare disease pipeline company to a focused gene therapy organization centered on RDEB treatment. The most pivotal development was the successful completion of the Phase III VITAL study for ZEVASKYN, which led to FDA approval in April 2025, marking the company's transition to a commercial-stage biopharmaceutical company. The company made several strategic portfolio decisions to concentrate resources on its highest-value programs. In 2022, Abeona signed an exclusive licensing agreement with Ultragenyx for its ABO-102 program targeting Sanfilippo syndrome type A, while discontinuing development of ABO-101 for MPS IIIB. This portfolio rationalization allowed the company to focus capital and management attention on ZEVASKYN's regulatory approval and commercial preparation. Manufacturing capabilities have been a key area of strategic investment. The company has systematically scaled its production capacity from initial capabilities to the current 4 patients per month, with plans to reach 6 patients per month by the end of 2025 and 8-10 patients monthly by early 2026. Long-term manufacturing goals target over 200 annual treatments by the second half of 2027, requiring additional GMP facility expansion planned for late 2027. Commercial infrastructure development has been another major focus area. Abeona has established the "Abeona Assist" patient support program, which has already received inquiries from 30 patients and families. The company has activated its first Qualified Treatment Center at Lurie Children's Hospital of Chicago and is onboarding additional specialized EB treatment centers. Market access efforts have included executing outcomes-based agreements with payer contracting organizations and engaging with commercial insurance and Medicaid programs. The company has also expanded its pipeline beyond RDEB, with particular emphasis on ophthalmology programs. The RS1 program for X-linked retinoschisis is on track for clinical trials in the second half of 2026, representing potential diversification beyond the current single-product focus. Additionally, Abeona has continued preclinical development work on treatments for Stargardt disease and autosomal dominant optic atrophy, though these remain in early-stage development.
ABEO company profile · for informational purposes only — not investment advice.
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