Dernières nouvelles pour Abeona Therapeutics (NASDAQ:ABEO) Stock

ABEONA THERAPEUTICS INC

Abeona Therapeutics

Abeona Therapeutics Inc is a clinical-stage biopharmaceutical company. The firm is focused on developing gene therapies and plasma-based products for life-threatening rare genetic diseases. Its clinical programs consist of pz-cel, an autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa (RDEB). The Company's development portfolio also features adeno-associated virus (AAV)-based gene therapies designed to treat unmet, medically needed ophthalmic diseases using the novel.

Abeona Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million on June 27, 2025.
Including net proceeds from the sale of the PRV, the Company reported that unaudited cash, cash equivalents, restricted cash and short-term investments&nbsp;as of June 30, 2025 were approximately $225 million.

News

ABEO

Abeona Therapeutics Nets $155M From Voucher Sale

Abeona Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) today announced that Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, has exercised its option to license Abeona's patented AAV204 capsid for use in potential gene therapies for a range of prevalent and rare retinal diseases that result in blindness. This worldwide, non-exclusive license is pursuant to the agreement between Abeona and Beacon, announced in July 2024, to evaluate the therapeutic potential of AAV204.
AAV204, a novel AAV capsid from the AIM&#x2122; capsid library licensed by Abeona from the University of North Carolina at Chapel Hill, has been shown to achieve high macular and optic nerve transduction levels after para-retinal administration and has also been shown to facilitate transduction of both the inner and outer retina after intravitreal administration in mice and non-human primates.
"Beacon's option exercise further validates AAV204's potential to enable targeted delivery of gene therapies in rare and prevalent ophthalmic diseases," said Dr. Madhav Vasanthavada, Chief Commercial Officer and Head of Business Development at Abeona Therapeutics. "Our non-exclusive agreement with Beacon enables us to fully explore the therapeutic value of AAV204 in additional ophthalmic diseases."
The exercise of this license option concludes Beacon's initial evaluation of the AAV204 capsid for development and commercialization of gene therapies and gives Beacon the right to use AAV204 in connection with up to five gene or ophthalmology disease targets. Under the terms of the agreement, Abeona will receive an undisclosed upfront license payment with additional payments upon the achievement of certain development, regulatory, and sales milestones, along with tiered royalties on worldwide net sales for licensed products incorporating AAV204.

Biotech

General

Abeona Therapeutics Announces It Has Exercised Its Option To License Abeona's Patented Aav204 Capsid For Use In Potential Gene Therapies

Abeona Therapeutics Added To Russell 2000 And Russell 3000 Indexes Following ZEVASKYN FDA Approval

<ul>
<li>RDEB is a lifelong debilitating, blistering skin disease associated with large and painful wounds that often remain open for years and cause significant clinical burden, including pain, itch, and risk of squamous cell carcinoma -</li>
<li>ZEVASKYN&#x2122; (prademagene zamikeracel) demonstrated significant wound healing and pain reduction after a single treatment with a favorable safety profile in large chronic RDEB wounds -</li>
<li>ZEVASKYN is the first and only autologous cell-based gene therapy FDA-approved to treat RDEB wounds in adult and pediatric patients -</li>
</ul>

Abeona Announces Publication Of Phase 3 VIITAL Study In The Lancet Highlighting ZEVASKYN's Impact On Chronic RDEB Wounds

Oppenheimer analyst Andreas Argyrides assumes Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) with a Outperform rating and announces Price Target of $19.

Price Target

Initiation

Analyst Ratings

Oppenheimer Assumes Abeona Therapeutics at Outperform, Announces Price Target of $19

U.S. stock futures were higher this morning, with the Dow futures gaining more than 500 points on Tuesday.
Shares of PDD Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PDD#NASDAQ">PDD</a>) fell sharply in today's pre-market trading following weaker-than-expected <a href="https://www.benzinga.com/quote/PDD">first-quarter results.</a>
PDD Holdings posted first-quarter earnings of $1.56 per share, missing market estimates of $2.49 per share. The company's sales came in at $13.18 billion versus expectations of $14.17 billion.
PDD shares dipped 15.2% to $101.11 in the pre-market trading session.
Here are some other stocks moving lower in pre-market trading.
<ul class="wp-block-list">
<li>Prothena Corporation plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTA#NASDAQ">PRTA</a>) shares fell 31.6% to $4.50 in pre-market trading after the company disclosed that Phase 3 AFFIRM-AL clinical trial for Birtamimab in patients with AL Amyloidosis did not meet primary endpoint.</li>
<li>Harmony Gold Mining Company Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HMY#NYSE">HMY</a>) declined 9.8% to $14.29 in pre-market trading after gaining more than 4% on Friday.</li>
<li>EHang Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EH#NASDAQ">EH</a>) shares fell 8.9% to $15.45 in pre-market trading. EHang Holdings posted a first-quarter adjusted loss of 6 cents per share, versus a year-ago loss of 2 cents per share.</li>
<li>Ruanyun Edai Technology Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RYET#NASDAQ">RYET</a>) shares dipped 8.5% to $12.22 in pre-market trading following a 3% decline on Friday.</li>
<li>Abeona Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) fell 6.1% to $6.03 in pre-market trading.</li>
<li>ZEEKR Intelligent Technology Holding Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ZK#NYSE">ZK</a>) fell 5.8% to $27.49 in pre-market trading.</li>
<li>Ascentage Pharma Group Internat (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPG#NASDAQ">AAPG</a>) fell 5.4% to $25.00 in pre-market trading.</li>
<li>H World Group Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HTHT#NASDAQ">HTHT</a>) declined 3.8% to $34.90 in pre-market trading.</li>
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Pre-Market Outlook

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PDD Holdings Posts Weak Results, Joins EHang Holdings And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session

Shares of E2open Parent Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ETWO#NYSE">ETWO</a>) rose sharply in today's pre-market trading after the company agreed to be acquired by WiseTech Global for $3.30 per share in all-cash deal <a href="https://www.benzinga.com/quote/ETWO">following strategic review</a>.
E2open Parent shares jumped 25.2% to $3.22 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul class="wp-block-list">
<li>SCWorx Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WORX#NASDAQ">WORX</a>) rose 52.5% to $0.6138 in pre-market trading.</li>
<li>MicroCloud Hologram Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HOLO#NASDAQ">HOLO</a>) jumped 37.5% to $7.43 in pre-market trading after falling 8% on Friday.</li>
<li>Incannex Healthcare Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IXHL#NASDAQ">IXHL</a>) surged 28.7% to $0.2799 in pre-market trading after gaining 8% on Friday. Incannex Healthcare, last week, announced it filed a prospectus supplement to increase the shares offered under its sales agreement to be worth $2.51 million.</li>
<li>CNFinance Holdings Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CNF#NYSE">CNF</a>) surged 20% to $0.57 in pre-market trading after dipping 12% on Friday. CNFinance will hold Annual General Meeting on May 29.</li>
<li>Diginex Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DGNX#NASDAQ">DGNX</a>) shares jumped 18% to $ 67.23 in pre-market trading after the company announced the signing of a Memorandum of Understanding for an all-share acquisition of Matter DK ApS.</li>
<li>Digital Ally, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DGLY#NASDAQ">DGLY</a>) climbed 16.7% to $2.92 in pre-market trading. Digital Ally, last week, announced a 1-for-100 reverse stock split.</li>
<li>Silo Pharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SILO#NASDAQ">SILO</a>) gained 16.2% to $0.4984 in pre-market trading.</li>
<li>SharpLink Gaming, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBET#NASDAQ">SBET</a>) rose 14.7% to $7.72 in pre-market trading after gaining 79% on Friday.</li>
<li>VivoPower International PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VVPR#NASDAQ">VVPR</a>) gained 14.1% to $6.99 in pre-market trading after gaining 24% on Friday.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul class="wp-block-list">
<li>Prothena Corporation plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTA#NASDAQ">PRTA</a>) shares fell 31.6% to $4.50 in pre-market trading after the company disclosed that Phase 3 AFFIRM-AL clinical trial for Birtamimab in patients with AL Amyloidosis did not meet primary endpoint.</li>
<li>Imunon, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IMNN#NASDAQ">IMNN</a>) fell 29.7% to $0.8151 in pre-market trading after the company reported up to $9.75 million private placement priced at-the-market under Nasdaq rules.</li>
<li>Oncolytics Biotech Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONCY#NASDAQ">ONCY</a>) shares dipped 25.9% to $0.31 in pre-market trading after gaining 4% on Friday.</li>
<li>Powell Max Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PMAX#NASDAQ">PMAX</a>) fell 17.2% to $0.4221 in pre-market trading after jumping 57% on Friday.</li>
<li>Lazydays Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GORV#NASDAQ">GORV</a>) shares tumbled 16.7% to $0.24 in pre-market trading after surging 55% on Friday.</li>
<li>BloomZ Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BLMZ#NASDAQ">BLMZ</a>) dipped 14.6% to $0.1790 in pre-market trading after jumping more than 56% on Friday. BloomZ, last week, announced a business alliance with M-NEXT holdings.</li>
<li>Cambium Networks Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMBM#NASDAQ">CMBM</a>) fell 11.7% to $0.37 in today's pre-market trading after dipping more than 10% on Friday.</li>
<li>Harmony Gold Mining Company Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HMY#NYSE">HMY</a>) declined 9.8% to $14.29 in pre-market trading after gaining more than 4% on Friday.</li>
<li>EHang Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EH#NASDAQ">EH</a>) shares fell 8.9% to $15.45 in pre-market trading. EHang Holdings posted a first-quarter adjusted loss of 6 cents per share, versus a year-ago loss of 2 cents per share.</li>
<li>Abeona Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) fell 6.1% to $6.03 in pre-market trading.</li>
</ul>
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Why E2open Shares Are Trading Higher By 25%; Here Are 20 Stocks Moving Premarket

Stifel analyst Dae Gon Ha maintains Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) with a Buy and lowers the price target from $21 to $20.

Stifel Maintains Buy on Abeona Therapeutics, Lowers Price Target to $20

Earnings

Earnings Beats

Abeona Therapeutics Q1 EPS $(0.24) Beats $(0.36) Estimate

Abeona Therapeutics And Lurie Children's Open Center For ZEVASKYNTM Gene Therapy To Treat Wounds Associated With Recessive Dystrophic Epidermolysis Bullosa

Abeona Therapeutics To Sell Priority Review Voucher For $155M Following FDA Approval Of ZEVASKYN

Abeona Therapeutics Inc.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) stock traded <a href="https://www.benzinga.com/general/biotech">higher on Wednesday.</a>
The Food and Drug Administration (FDA) on Tuesday approved Abeona&#8217;s Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for wounds in adult and pediatric patients with recessive dystrophic <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">epidermolysis bullosa (RDEB)</a>.
Zevaskyn is the only FDA-approved product to treat RDEB wounds&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/45080457/abeona-therapeutics-wins-fda-approval-for-first-of-its-kind-gene-therapy" rel="noreferrer noopener">with a single application</a>.
Zevaskyn consists of a patient's skin cells (keratinocytes) genetically modified to produce functional Type VII collagen. Zevaskyn sheets are surgically applied to the patient's wounded areas. In a single application, up to 12 credit card-sized sheets can be combined to cover large areas or applied to multiple distinct wounds, allowing for significant coverage of affected body areas.
HC Wainwright writes the approval was granted on time, showing that the agency can still meet deadlines despite recent disruptions. Analyst Raghuram Selvaraju on Wednesday wrote that pz-cel is well-positioned to become the leading treatment for the most severe cases of recessive dystrophic epidermolysis bullosa (RDEB).
It may also be used on its own or alongside other approved treatments like Krystal Biotech, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KRYS#NASDAQ">KRYS</a>) Vyjuvek (beremagene geperpavec) in certain patients.
On Monday, the European Commission approved Vyjuvek for wounds in patients with dystrophic epidermolysis bullosa who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g45034979/krystal-biotech-announces-european-commission-approval-of-vyjuvek-for-the-treatment-of-dystrophic-" rel="noreferrer noopener">starting from birth</a>.
<ul>
<li>The timing for the availability of VYJUVEK in individual countries will depend on multiple factors, including the completion of reimbursement procedures.</li>
<li>The company is planning for its first European launch in Germany in mid-2025.</li>
</ul>
The list price for Zevaskyn has been revealed at $3.1 million per treatment, much higher than the $800,000 we previously assumed, the analyst said.
Based on this new price, the analyst estimates that treating 10–15 patients by the end of 2025 could bring Abeona over $30 million in sales.
HC Wainwright&#8217;s updated revenue forecast for 2025 is now $31.6 million, increasing to $130.4 million in 2026.
HC Wainwright continues to project peak U.S. sales of around $600 million. Abeona believes there are about 750 potential patients in the target population, which could mean a market opportunity of over $2 billion if all were treated with Zevaskyn.
Analyst Selvaraju <a target="_blank" href="https://www.benzinga.com/quote/ABEO/analyst-ratings" rel="noreferrer noopener">maintains the Buy rating</a> and raise the price target from $15 to $20 per share, reflecting increased confidence in the drug.
Price Action: ABEO stock was up 23.77% to $6.56 on Wednesday.
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Photo: Shutterstock

Analyst Color

Health Care

KRYS

Abeona Surges After FDA Clears First Gene Therapy For Severe Genetic Skin Disease

Abeona Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) shares are trading higher on Wednesday on possible continued strength after the Food and Drug Administration (FDA) announced approval for <a href="https://www.benzinga.com//node/45080457">its gene therapy.</a> 
What To Know: The FDA announced on Tuesday approval of ZEVASKYN, a gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (REDB).
The stock hit a new 52-week high of $7.32 today as a result, surpassing its previous peak of $6.78, per data <a href="https://www.benzinga.com/pro/">Benzinga Pro.</a>
The FDA approval is based on the pivotal Phase 3 VITAL study that showed the therapy resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile.
&#8220;Today&#8217;s approval of ZEVASKYN represents a pivotal moment in the treatment of RDEB, answering the call of people living with the clinical, economic, and human impact of this devastating disease,&#8221; said Vish Seshadri, Ph.D., M.B.A., CEO of Abeona. 
Following the FDA approval of ZEVASKYN, HC Wainwright &amp; Co. analyst Raghuram Selvaraju maintained a Buy rating on Abeona Therapeutics and raised the price target from&nbsp;$15&nbsp;to&nbsp;$20.
See Also: <a href="https://www.benzinga.com/personal-finance/25/04/45110643/dividend-investor-who-earned-18000-a-month-despite-bloody-selloff-shares-his-top-6-stock-picks">Dividend Investor Who Earned $18,000 a Month Despite &#8216;Bloody&#8217; Selloff Shares His Top 6 Stock Picks</a>
ABEO Price Action: At the time of publication, Abeona shares are trading 27.1% higher at $6.73, according to data from <a href="https://www.benzinga.com/pro/">Benzinga Pro.</a>
Image: via Shutterstock

Abeona Stock Surges to 52-Week High: What's Behind The Move?

<h3>Gainers</h3>
<ul>
<li>Regulus Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGLS#NASDAQ">RGLS</a>) shares increased by 132.5% to $7.83 during Wednesday's regular session. The company's market cap stands at $519.0 million. </li>
<li>Regencell Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) stock increased by 71.13% to $54.08. The company's market cap stands at $703.7 million. </li>
<li>INVO Fertility (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IVF#NASDAQ">IVF</a>) shares increased by 62.72% to $2.62. The company's market cap stands at $12.9 million. As per the press release, Q4 earnings came out 2 days ago. </li>
<li>Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) shares moved upwards by 30.18% to $6.9. The market value of their outstanding shares is at $334.8 million. </li>
<li>Nutriband (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NTRB#NASDAQ">NTRB</a>) stock increased by 24.26% to $7.06. The company's market cap stands at $78.3 million. </li>
<li>Brainstorm Cell (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCLI#NASDAQ">BCLI</a>) stock rose 20.73% to $1.31. The market value of their outstanding shares is at $7.4 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>GeneDx Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WGS#NASDAQ">WGS</a>) stock declined by 38.7% to $71.69 during Wednesday's regular session. The company's market cap stands at $2.0 billion. As per the news, the Q1 earnings report came out today. </li>
<li>NanoVibronix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAOV#NASDAQ">NAOV</a>) stock decreased by 23.59% to $2.83. The company's market cap stands at $2.3 million. </li>
<li>Coeptis Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COEP#NASDAQ">COEP</a>) stock declined by 21.78% to $7.76. The market value of their outstanding shares is at $25.1 million. </li>
<li>Zynex (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZYXI#NASDAQ">ZYXI</a>) stock fell 21.53% to $1.75. The market value of their outstanding shares is at $52.8 million. The company's, Q1 earnings came out yesterday. </li>
<li>Immunic (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IMUX#NASDAQ">IMUX</a>) shares decreased by 15.63% to $1.08. The company's market cap stands at $103.4 million. </li>
<li>Cellectar Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CLRB#NASDAQ">CLRB</a>) shares fell 15.54% to $0.25. The market value of their outstanding shares is at $11.3 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Wednesday's Intraday Session

WIIM

Abeona Therapeutics shares are trading higher after HC Wainwright & Co. raised its price target on the stock from $15 to $20. Additionally, the stock may be moving on continued strength after announcing yesterday FDA for its gene therapy.

HC Wainwright &amp; Co. analyst Raghuram Selvaraju maintains Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) with a Buy and raises the price target from $15 to $20.

HC Wainwright & Co. Maintains Buy on Abeona Therapeutics, Raises Price Target to $20

The U.S. Food and Drug Administration (FDA) on Tuesday approved Abeona Therapeutics Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for wounds in adult and pediatric patients with recessive dystrophic <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">epidermolysis bullosa (RDEB)</a>.
RDEB is&nbsp;a severe, genetically inherited skin disorder characterized by blistering and skin fragility, often presenting at birth.
Zevaskyn is the only FDA-approved product to treat RDEB wounds <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g45061116/u-s-fda-approves-zevaskyn-prademagene-zamikeracel-the-first-and-only-cell-based-gene-therapy-for-p" rel="noreferrer noopener">with a single application</a>.
Zevaskyn consists of a patient&#8217;s skin cells (keratinocytes) genetically modified to produce functional Type VII collagen. Zevaskyn sheets are surgically applied to the patient&#8217;s wounded areas. In a single application, up to 12 credit card-sized sheets can be combined to cover large areas or applied to multiple distinct wounds, allowing for significant coverage of affected body areas.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44356786/incytes-new-treatment-for-chronic-skin-disease-shows-promising-results-in-latest-clinical-trials-" rel="noreferrer noopener">Incyte&#8217;s New Treatment for Chronic Skin Disease Shows Promising Results In Latest Clinical Trials, Stock Falls</a>
Zevaskyn is expected to be available beginning in the third quarter of 2025 through Zevaskyn Qualified Treatment Centers.
The FDA approval is based on the pivotal Phase 3 VIITAL study, which met its two co-primary efficacy endpoints, demonstrating statistically significant healing of 50% or more from baseline in large chronic RDEB wounds and pain reduction from baseline as assessed by the Wong-Baker FACES scale, as evaluated at six months after treatment.
Across 43 large and chronic wounds treated with a single application of Zevaskyn, 81% of wounds showed 50% or more healing (P&lt;0.0001) as evaluated at six months, compared to 16% in 43 matched control wounds treated with standard-of-care.
The most common adverse events were observed in fewer than 5% of patients, including procedural pain and itch.
The Phase 1/2a study of Zevaskyn, which involved 38 chronic wounds across seven patients, showed that a single surgical application of Zevaskyn was associated with long-term improvement at treated sites over a median follow-up of 6.9 years, ranging from 4 to 8 years.
Last April, the FDA issued a Complete Response Letter (CRL) in response to the company&#8217;s Biologics License Application (BLA) for <a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38380100/fda-rejects-approval-of-abeona-therapeutics-skin-disorder-treatment-shares-sink" rel="noreferrer noopener">pz-cel for RDEB</a>.&nbsp;
The FDA noted that certain additional information&nbsp;was needed&nbsp;to&nbsp;satisfy Chemistry Manufacturing and Controls (CMC) requirements.&nbsp;
Price Action: ABEO stock is up 2.34% at $5.46 at the last check Tuesday.
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Abeona Therapeutics Wins FDA Approval For First-of-Its-Kind Gene Therapy

ABEO stock has given up its prior gain. Abeona Therapeutics shares were trading higher after the company announced FDA approval of ZEVASKYN for treating wounds in patients with recessive dystrophic epidermolysis bullosa.

Abeona Therapeutics shares are trading higher after the company announced FDA approval of ZEVASKYN for treating wounds in patients with recessive dystrophic epidermolysis bullosa.

<ul>
<li>ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure.</li>
<li>Approval based on the pivotal Phase 3 VIITAL study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile.</li>
<li>ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025.</li>
<li>Abeona Assist patient services program offers personalized support for eligible patients and families throughout their treatment journey with ZEVASKYN.</li>
<li>Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA</li>
</ul>

The FDA Approves Abeona Therapeutics' Zevaskyn (Prademagene Zamikeracel) Gene-modified Cellular Sheets, Also Known As Pz-cel, As The First And Only Autologous Cell-based Gene Therapy For Wounds In Adult And Pediatric Patients With Recessive Dystrophic Epidermolysis Bullosa

Press Releases

Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYNTM Gene Therapy to Treat Wounds in Painful Skin Disorder

UPDATE -- Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYN™ Gene Therapy to Treat Wounds in Painful Skin Disorder

Abeona Therapeutics® Reports First Quarter 2025 Financial Results and Corporate Updates

Abeona Therapeutics® to Present at the Jefferies Global Healthcare Conference

Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Abeona Therapeutics® Announces Publication in The Lancet of Phase 3 VIITAL™ Study Data in Recessive Dystrophic Epidermolysis Bullosa

Abeona Therapeutics® added to Membership of U.S. Small-cap Russell 2000® Index and Broad-market Russell 3000® Index

Abeona Therapeutics® Announces Option Exercise by Beacon Therapeutics for Novel AAV204 Capsid for Ophthalmology Gene Therapy

Abeona Therapeutics® Closes Sale of Rare Pediatric Disease Priority Review Voucher for $155 Million

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