Abeona Therapeutics Azioni (NASDAQ: ABEO)

Ultime notizie per Abeona Therapeutics (NASDAQ:ABEO) Azioni

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

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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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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Photo via Shutterstock

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

HC Wainwright &amp; Co. analyst Mitchell Kapoor reiterates Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) with a Buy and maintains $15 price target.

Reiteration

HC Wainwright & Co. Reiterates Buy on Abeona Therapeutics, Maintains $15 Price Target

Earnings

Abeona Therapeutics 2024 EPS $(1.55) Up From $(2.53) YoY

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Canaccord Genuity analyst John Newman initiated coverage on Marker Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRKR#NASDAQ">MRKR</a>) with a Buy rating and announced a price target of $8. Marker Therapeutics shares closed at $1.38 on Tuesday. <a href="https://www.benzinga.com/quote/mrkr/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Jefferies analyst Roger Song initiated coverage on Krystal Biotech, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KRYS#NASDAQ">KRYS</a>) with a Buy rating and announced a price target of $245. Krystal Biotech shares closed at $175.22 on Tuesday. <a href="https://www.benzinga.com/quote/krys/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Barclays analyst Thomas O&#8217;Malley initiated coverage on Sandisk Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDK#NASDAQ">SNDK</a>) with an Equal-Weight rating and announced a price target of $50. SanDisk shares closed at $48.69 on Tuesday. <a href="https://www.benzinga.com/quote/sndk/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Mizuho analyst Maheep Mandloi initiated coverage on Fluence Energy, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FLNC#NASDAQ">FLNC</a>) with an Outperform rating and announced a price target of $8. Fluence Energy shares closed at $5.21 on Tuesday. <a href="https://www.benzinga.com/quote/flnc/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Oppenheimer analyst Francois Brisebois initiated coverage on Abeona Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) with an Outperform rating and announced a price target of $16. Abeona Therapeutics shares closed at $5.07 on Tuesday. <a href="https://www.benzinga.com/quote/abeo/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
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This Krystal Biotech Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Wednesday

Oppenheimer analyst Francois Brisebois initiates coverage on 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 $16.

Oppenheimer Initiates Coverage On Abeona Therapeutics with Outperform Rating, Announces Price Target of $16

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

Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) reported quarterly losses of $(0.63) per share which missed the analyst consensus estimate of $(0.40) by 57.5 percent. This is a 31.25 percent decrease over losses of $(0.48) per share from the same period last year.

Earnings Misses

Abeona Therapeutics Q3 2024 GAAP EPS $(0.63) Misses $(0.40) Estimate

Abeona Therapeutics Announces FDA Acceptance Of BLA Resubmission For Pz-cel In Recessive Dystrophic Epidermolysis Bullosa

Cantor Fitzgerald analyst Kristen Kluska reiterates Abeona Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABEO#NASDAQ">ABEO</a>) with a Overweight and maintains $18 price target.

Cantor Fitzgerald Reiterates Overweight on Abeona Therapeutics, Maintains $18 Price Target

Abeona Therapeutics Has Resubmitted Its Biologics License Application To The FDA For Prademagene Zamikeracel (Pz-cel), Its Investigational Autologous Cell-based Gene Therapy For Recessive Dystrophic Epidermolysis Bullosa

Press Releases

Abeona Therapeutics® Reports Third Quarter 2024 Financial Results and Recent Corporate Updates

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

Abeona Therapeutics® to Present at the Leerink Partners Global Healthcare Conference

Abeona Therapeutics® Reports Full Year 2024 Financial Results, Provides Pz-cel Regulatory Update and Commercial Launch Plans

U.S. FDA Approves ZEVASKYN™ (prademagene zamikeracel), the First and Only Cell-Based Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

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