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Cincinnati Children's Activated as the Seventh Qualified Treatment Center for ZEVASKYN®

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Abeona Therapeutics (Nasdaq: ABEO) announced that Cincinnati Children’s has been activated as the seventh Qualified Treatment Center (QTC) for administering ZEVASKYN (prademagene zamikeracel), an autologous gene-modified cellular sheet therapy for wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).

Cincinnati Children’s, described as one of the largest epidermolysis bullosa centers in the US, can now offer ZEVASKYN to adult and pediatric RDEB patients. Abeona highlighted its Abeona Assist program, which provides personalized support for insurance, financial assistance, and travel logistics. The release also reiterates ZEVASKYN’s mechanism, indication, clinically meaningful wound healing and pain reduction after a single surgical application, and key safety information, including risks of allergic reactions, potential cancer risk, infection transmission, and common side effects such as procedural pain and itching.

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Positive

  • Seventh ZEVASKYN Qualified Treatment Center activated at Cincinnati Children’s, expanding U.S. treatment network
  • Access infrastructure supported by Abeona Assist for insurance, financial, travel, and logistical help

Negative

  • None.

News Market Reaction – ABEO

+0.77%
3 alerts
+0.77% Session close to close
$398.97M Market Cap
0.3x Rel. Volume

In the Jul 21 session, ABEO gained 0.77%, reflecting a mild positive market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

A prior ZEVASKYN center activation was followed by a -0.68% 24-hour move, providing a directly relev...
Analysis

A prior ZEVASKYN center activation was followed by a -0.68% 24-hour move, providing a directly relevant historical comparison. Recent insider records showed Net Selling; treatment-center utilization remains important to monitor.

Key Figures

Qualified Treatment Centers: seventh Qualified Treatment Center Product distinction: first and only COL7A1 gene copies: 2 copies +1 more
4 metrics
Qualified Treatment Centers seventh Qualified Treatment Center ZEVASKYN administration
Product distinction first and only Autologous gene-modified cellular sheets
COL7A1 gene copies 2 copies RDEB disease description
Surgical applications single surgical application Reported wound healing and pain reduction

Historical Context

5 past events · Latest: Jul 01 (Negative)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 01 Employee inducement grants Negative -2.1% Restricted stock awards totaling up to 9,000 shares preceded a 2.1% decline.
Jun 01 Employee inducement grants Negative -2.6% Restricted stock awards covering up to 13,800 shares preceded a 2.6% decline.
May 26 Investor conference participation Neutral +0.9% Upcoming healthcare conference participation preceded a 0.92% increase.
May 13 First-quarter earnings Positive +0.5% Reported $8.7 million net product revenue and cash of $168.3 million.
May 11 Treatment-center activation Positive -0.7% CHOP became the sixth Qualified Treatment Center, preceding a 0.68% decline.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

ABEO's prior access-center announcement coincided with a -0.68% move, while earnings news coincided with a 0.53% increase; recent grant notices were followed by declines.

Key Terms

autologous, ex vivo, replication-incompetent retroviral vector, COL7A1, +2 more
6 terms
autologous medical
"the first and only autologous gene-modified cellular sheets"
Autologous describes a medical product or treatment made from a patient’s own cells or tissues rather than from a donor. For investors, autologous approaches matter because they can lower the risk of immune rejection and improve effectiveness, but they often require individualized manufacturing, complex logistics, and higher per-patient costs—factors that affect scalability, pricing, and regulatory hurdles in healthcare businesses.
ex vivo medical
"incorporates the functional type VII collagen-producing COL7A1 gene into a patient’s own skin cells, ex vivo"
Ex vivo describes tests or treatments performed on living cells, tissues, or organs that have been removed from the body and studied in an external environment. For investors, ex vivo work sits between basic lab dish tests and whole‑animal or human studies, offering a more realistic preview of how a therapy or diagnostic might behave in real tissue — like running an engine on a test stand before putting it back into a car — which can reduce scientific risk and inform development milestones.
replication-incompetent retroviral vector technical
"using a replication-incompetent retroviral vector to produce functional type VII collagen"
A replication-incompetent retroviral vector is a laboratory-made virus shell that can deliver genetic material into target cells but has been engineered so it cannot reproduce itself. Think of it as a delivery van stripped of the parts needed to make more vans: it carries a payload into cells without spawning new viruses. It matters to investors because these vectors are key tools in developing and manufacturing gene therapies and cell therapies, with direct implications for safety profiles, regulatory review, production complexity, and commercial value.
COL7A1 medical
"a defect in both copies of the COL7A1 gene"
COL7A1 is the gene that makes type VII collagen, a structural protein that acts like tiny rivets holding skin layers together; defects in this gene cause inherited blistering skin disorders. It matters to investors because therapies, diagnostics, or clinical trial results tied to COL7A1 can drive biotechnology company valuation, partnership deals, or regulatory milestones, much like the performance of a single key part can determine whether a new machine succeeds.
anaphylaxis medical
"a severe reaction called anaphylaxis may happen"
Anaphylaxis is a sudden, severe allergic reaction in which the body's defense system overreacts to a trigger (like a drug, food, or insect sting), causing widespread symptoms such as difficulty breathing, low blood pressure, and shock; it can be life‑threatening without prompt treatment. Investors care because anaphylaxis risks can affect a drug or product's safety profile, regulatory approval, liability exposure and market acceptance—similar to a sprinkler system going off and damaging the whole house rather than just one room.
cGMP regulatory
"fully integrated cell and gene therapy cGMP manufacturing facility"
cGMP (current Good Manufacturing Practice) are government-enforced quality standards that manufacturers must follow to ensure drugs, medical devices, and related products are made consistently, safely, and meet specified quality tests. For investors, cGMP compliance is like a restaurant passing health inspections: it reduces the risk of product recalls, regulatory fines, or production stoppages that can hurt revenue and company value, and it supports market access and long-term trust.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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CLEVELAND, July 21, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced the activation of Cincinnati Children’s as the seventh Qualified Treatment Center (QTC) for the administration of ZEVASKYN® (prademagene zamikeracel), the first and only autologous gene-modified cellular sheets for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).

“Cincinnati Children's is one of largest EB centers in the US and we are thrilled to announce its activation as a ZEVASKYN QTC. We look forward to collaborating with Cincinnati Children’s to make ZEVASKYN available to RDEB patients in need,” said Dr. Madhav Vasanthavada, Chief Commercial Officer of Abeona.

“As one of the centers caring for a large number of patients with RDEB, we see firsthand the profound impact this condition has on patients and their families,” said Dr. Kalyani S. Marathe, MD, MPH, Professor, UC Department of Pediatrics, UC Department of Dermatology. “We are excited to offer ZEVASKYN to our patients who have been desperate for innovations that will make their lives better. I’m proud to be a part of our EB team which has cared for this population for decades and thrilled that Cincinnati Children’s can provide this cutting-edge treatment.

For more information about receiving ZEVASKYN treatment at Cincinnati Children’s, contact the EB Center at ebcenter@cchmc.org.

For more information on how to access ZEVASKYN and learn about patient support services offered through Abeona Assist®, Abeona’s comprehensive patient support program, visit www.abeonaassist.com, call 1-855-ABEONA-1 (1-855-223-6621) or email MyNavigator@AbeonaAssist.com. Abeona Assist offers personalized support, including helping eligible patients understand their insurance benefits and financial assistance options, and providing travel and logistical assistance.

About recessive dystrophic epidermolysis bullosa
Recessive dystrophic epidermolysis bullosa (RDEB), a rare blistering disorder without a cure, is characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in both copies of the COL7A1 gene, leaving them unable to produce functioning type VII collagen, which is necessary to anchor the dermal and epidermal layers of the skin.

About ZEVASKYN® (prademagene zamikeracel) gene-modified cellular sheets
ZEVASKYN is the first and only autologous cell sheet-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a severe skin disease caused by a defect in both copies of the COL7A1 gene resulting in the inability to produce functional type VII collagen. Without functional type VII collagen and anchoring fibrils, the skin is fragile and blisters easily, leading to wounds that continually open and close, or fail to heal altogether. Patients often have large open wounds that can lead to serious life-threatening complications. ZEVASKYN incorporates the functional type VII collagen-producing COL7A1 gene into a patient’s own skin cells, ex vivo, using a replication-incompetent retroviral vector to produce functional type VII collagen in treated wounds. ZEVASKYN has demonstrated clinically meaningful wound healing and pain reduction with a single surgical application. For more information, visit www.ZEVASKYN.com.

Indication
ZEVASKYN® (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).

Important Safety Information

  • Serious allergic reactions to ZEVASKYN can occur. Patients should get medical help right away if they experience symptoms like itching, swelling, hives, difficulty breathing, runny nose, watery eyes, or nausea. In rare cases, a severe reaction called anaphylaxis may happen.
  • There is a potential risk that treatment with ZEVASKYN may contribute to the development of cancer because of how the therapy works. Patients should be monitored for the rest of their lives to check for any signs of cancer.
  • ZEVASKYN is made using human and animal materials. Although these materials are tested before use, the risk of passing on infections cannot be eliminated.
  • The most common side effects are pain from the procedure and itching.

This is not a complete list of side effects. Patients should call their care team for medical advice about side effects. Side effects may be reported to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See full Prescribing Information.

About Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with RDEB. The Company’s fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features ABO-701 (PSMA-SIR-T™), a potentially first-in-class engineered T-cell therapy targeting PSMA, engineered to overcome the core failures of cell therapies in solid tumors. For more information, visit www.abeonatherapeutics.com.

ZEVASKYN®, Abeona Assist®, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.

Forward-Looking Statements
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “expect,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, our ability to successfully commercialize and market ZEVASKYN, including manufacturing sufficient batches of ZEVASKYN to meet demand; the therapeutic potential of ZEVASKYN; whether the unmet need and market opportunity for ZEVASKYN are consistent with the Company’s expectations; continued interest in our portfolio; our ability to submit an investigational new drug application for ABO-701 and enroll patients in clinical trials; the outcome of future meetings with and inspections by the FDA or other regulatory agencies, including those relating to preclinical programs and to the cGMP manufacturing of ZEVASKYN; the ability to achieve or obtain necessary regulatory approvals for our pre-clinical programs; our ability to execute on our key business priorities; the impact of any changes in the financial markets and global economic conditions, including those resulting from changes to U.S. or other countries’ trade policy, such as current or future tariffs; risks associated with data analysis and reporting; and other risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise these forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.



Contacts:
Investor and Media
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com

Investor
Lee M. Stern
Meru Advisors
lstern@meruadvisors.com

FAQ

What did Abeona Therapeutics (ABEO) announce about ZEVASKYN on July 21, 2026?

Abeona Therapeutics announced activation of Cincinnati Children’s as the seventh Qualified Treatment Center for ZEVASKYN. According to Abeona, this enables the hospital to administer the autologous gene-modified cellular sheet therapy to eligible recessive dystrophic epidermolysis bullosa (RDEB) patients and expands the product’s clinical access network in the United States.

What is ZEVASKYN (prademagene zamikeracel) used for in patients with RDEB?

ZEVASKYN is indicated for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. According to Abeona, it is an autologous cell sheet-based gene therapy that adds a functional COL7A1 gene to a patient’s skin cells ex vivo, supporting type VII collagen production in treated wounds.

Why is Cincinnati Children’s activation important for ZEVASKYN access for ABEO?

Cincinnati Children’s is described as one of the largest epidermolysis bullosa centers in the U.S., caring for many RDEB patients. According to Abeona, its activation as a ZEVASKYN Qualified Treatment Center increases the number of facilities able to deliver the therapy, potentially improving geographic access for eligible patients.

What are the key safety risks of ZEVASKYN highlighted for ABEO investors?

Key risks include serious allergic reactions, including rare anaphylaxis, a potential cancer risk due to the therapy’s mechanism, and theoretical infection transmission. According to Abeona, common side effects are procedure-related pain and itching, and patients require lifelong monitoring for potential cancer development.

How does ZEVASKYN work as a gene-modified cellular sheet therapy for RDEB?

ZEVASKYN uses a patient’s own skin cells modified ex vivo with a replication-incompetent retroviral vector carrying the COL7A1 gene. According to Abeona, the resulting cellular sheets are surgically applied to wounds to produce functional type VII collagen, supporting clinically meaningful wound healing and pain reduction.

What support services does Abeona Assist offer to ZEVASKYN patients and caregivers?

Abeona Assist offers personalized support including help understanding insurance benefits, financial assistance options, and travel and logistical arrangements. According to Abeona, the program is designed to assist eligible ZEVASKYN patients and families in navigating access, with contact available via website, phone, and email.