Abeona Therapeutics

Abeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life-threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA), and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in New York, NY.

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Abeona Therapeutics excels in Q4 with EB-101 advancements and growth prospects

Abeona Therapeutics showcased strong financial performance and clinical advancements with EB-101 in Q4 2022.
While facing challenges in pricing negotiations and upcoming competition, the company is well-positioned for growth.
Opportunities lie in partnerships for commercialization, market acceptance of EB-101, and the potential of gene therapy programs.

Abeona Therapeutics reports strong Q1 performance and eyes future growth

Abeona Therapeutics showcased strong performance in Q1 2023 with positive data from EB-101 and AAV ophthalmology programs, driving patient confidence and market positioning.
The company's engagement with stakeholders, successful completion of key submission steps, and promising proof-of-concept data present opportunities for future growth.
Challenges include aligning pricing considerations post VIITAL results, meeting submission requirements, and addressing analyst inquiries on program priorities and study findings.

Abeona Therapeutics advances EB-101 with $100M voucher, faces commercialization challenges

Abeona Therapeutics showcased progress on EB-101 and financial stability despite a net loss in Q2 2023.
Challenges include financial losses, commercial launch readiness, and securing partnerships.
Opportunities lie in potential BLA approval, market expansion, and advancements in AAV-based therapies.
The company's focus on EB-101 and strategic planning for commercialization are key strengths.

Abeona Therapeutics advances BLA submission for pz-cel, eyes commercialization

Abeona Therapeutics is making significant strides in product approval and commercialization strategies.
The company's financial stability and market-focused approach position it well for future growth.
While challenges exist, opportunities for expansion through FDA approval and market engagement are promising.

Abeona Therapeutics advances towards U.S. commercialization with FDA acceptance

Abeona Therapeutics showcased strong progress towards U.S. commercialization with FDA acceptance for pz-cell BLA. The company's financial performance for 2023 was solid, and engagement with key stakeholders bodes well for market entry. Challenges in FDA response timelines and manufacturing inspections need careful management.

Abeona Therapeutics advances pz-cel resubmission and strengthens financial position

Abeona Therapeutics shows strong progress in addressing regulatory and commercialization aspects for pz-cel
Financial stability improved through successful underwritten offering, enhancing market position
Challenges remain in FDA feedback, site onboarding, PRV market dynamics, and self-launch commitment
Clear opportunities exist in collaborations, market potential, growth timeline, and strategic positioning

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Abeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life-threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA), and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in Cleveland, OH.

NEW YORK and CLEVELAND, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the company will present at the 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24, 2021 at 11:20 am EST.

Abeona Therapeutics to Present at the 10th Annual SVB Leerink Global Healthcare Conference

In addition to preservation of neurocognitive development with ABO-102 in MPS IIIA, new clinical results of ABO-102 in MPS IIIA and ABO-101 in MPS IIIB continue to show dose-dependent and sustained reductions in disease-specific biomarkers, denoting clear biologic effects

New Positive Phase 1/2 Interim Data Presented at WORLDSymposium™ Shows Neurocognitive Development of Young MPS IIIA Patients Preserved up to Three Years Following Treatment with Abeona's ABO-102 Gene Therapy

NEW YORK and CLEVELAND, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that it will host a live webinar for the investment community on Tuesday, February 16, 2021 at 1:00 p.m. EST to review clinical data on the company's investigational AAV-based gene therapies ABO-102 and ABO-101 presented at the 17th Annual WORLDSymposium™.

Abeona Therapeutics Announces Clinical Investigator Webinar to Review ABO-102 and ABO-101 Clinical Data Presented at the 17th Annual WORLDSymposium™

Clinical trial amendment successfully completed for co-primary endpoints of partial wound closure and mean pain reduction Clinical trial amendment successfully completed for co-primary endpoints of partial wound closure and mean pain reduction

Abeona Therapeutics Announces Successful Type B Meeting with FDA for Pivotal Phase 3 VIITAL™ Study of EB-101 in Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Investors need to pay close attention to Abeona (ABEO) stock based on the movements in the options market lately.

Do Options Traders Know Something About Abeona (ABEO) Stock We Don't?

NEW YORK and CLEVELAND, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that abstracts detailing new interim results from its ABO-102 Phase 1/2 Transpher A study for MPS IIIA and ABO-101 Phase 1/2 Transpher B study for MPS IIIB have been accepted for platform oral presentations during the late-breaking abstract session at the 17th Annual WORLDSymposium™ being held February 8-12, 2021.

Abeona Therapeutics Announces Acceptance of Late-Breaker Abstracts Highlighting New Clinical Data for Novel AAV-based Gene Therapies in MPS IIIA and MPS IIIB at WORLDSymposium™

Is the Options Market Predicting a Spike in Abeona (ABEO) Stock?

Abeona Therapeutics Inc's (NASDAQ: ABEO) stock does not reflect the company's in-house manufacturing capabilities and pipeline, according to Cantor Fitzgerald. The Abeona Therapeutics Analyst: Kristen Kluska upgraded Abeona Therapeutics from Neutral to Overweight while maintaining the price target at $4.

Why This Abeona Therapeutics Analyst Is Turning Bullish After Q3 Print

Abeona Therapeutics (ABEO) delivered earnings and revenue surprises of 38.46% and 0.00%, respectively, for the quarter ended September 2020. Do the numbers hold clues to what lies ahead for the stock?

Abeona Therapeutics (ABEO) Reports Q3 Loss

NEW YORK and CLEVELAND, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that Michael Amoroso, Senior Vice President and Chief Commercial Officer at Abeona, has been promoted to Chief Operating Officer and will serve as the Company's principal executive and operating officer, effective November 1, 2020. In this newly created role at Abeona, Mr. Amoroso's responsibilities will broaden to include oversight and leadership of all operations; including but not limited to, research and clinical development, regulatory, medical, commercial, corporate affairs and business development.

Abeona Therapeutics Announces the Appointment of Michael Amoroso as Chief Operating Officer

Steven H. Rouhandeh Appointed as Chairman of the Board of Directors

Abeona Therapeutics’ Board of Directors Forms Special Committee to Oversee Operations, Develop Strategic Direction and Leadership Plan

NEW YORK and CLEVELAND, Sept.  28, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced changes in its executive leadership and Board of Directors. João Siffert, M.D. resigned from his positions as CEO, Head of Research and Development, and Chief Medical Officer, as well as member of the Board of Directors, on September 23, 2020. On September 27, 2020, Brian Pereira, M.D., Stefano Buono, Stephen B. Howell, M.D., George Migausky and Shawn Tomasello each announced that they had stepped down from the Board, effective immediately. No director gave any reason for their resignation and no director indicated any disagreements with the Company.

Abeona Therapeutics Announces Leadership and Board Transitions

NEW YORK and CLEVELAND, Sept.  08, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the Company will participate in the following upcoming investor conferences.

Abeona Therapeutics to Participate in Upcoming Investor Conferences

NEW YORK and CLEVELAND and DALLAS, Aug.  17, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, and Taysha Gene Therapies, a patient-centric gene therapy company with a mission to eradicate monogenic CNS disease, today announced that they have entered into license and inventory purchase agreements for ABO-202, an adeno-associated virus (AAV) gene therapy for CLN1 disease (also known as infantile Batten disease). The agreements grant Taysha worldwide exclusive rights to intellectual property developed by scientists at the University of North Carolina at Chapel Hill (UNC) and Abeona, and Abeona know-how relating to the research, development, and manufacture of ABO-202. The therapy was originally developed in the lab of Steven Gray, Ph.D., Associate Professor at UT Southwestern Medical Center (formerly with UNC) and Chief Scientific Advisor for Taysha Gene Therapies. Abeona continued to progress the program, including development of the Phase 1/2 clinical trial protocol and manufacturing process, and received FDA clearance of its Investigational New Drug (IND) Application for a Phase 1/2 clinical trial that is anticipated to enter the clinic in 2021.

Abeona Therapeutics and Taysha Gene Therapies Enter into Licensing and Inventory Purchase Agreements for ABO-202, a Clinical Stage, Novel, One-time Gene Therapy for CLN1 Disease

Additional patients dosed in RDEB, MPS IIIA and MPS IIIB clinical programs

Abeona Therapeutics Reports Second Quarter Financial Results and Business Updates

NEW YORK and CLEVELAND, July  10, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that two poster presentations related to its clinical program for recessive dystrophic epidermolysis bullosa (RDEB) were featured at the Society for Pediatric Dermatology (SPD) 45th Annual Meeting. The first poster includes a detailed analysis of patients with RDEB in the EB-101 Phase 1/2a trial showing that wound healing following EB-101 treatment was associated with improved long-term pain relief. A separate poster provides insights on the significant disease burden associated with RDEB, highlighting data from a literature review on the clinical characteristics, humanistic consequences and economic impact of living with RDEB on patients and their families.

Abeona Therapeutics Announces Two Presentations Related to Its RDEB Clinical Program at the Society for Pediatric Dermatology 45th Annual Meeting

Abeona (ABEO) restarts patient enrollment in phase III VIITAL study of EB-101 for the treatment of recessive dystrophic epidermolysis bullosa.

Abeona Restarts Enrollment in Connective Tissue Disorder Study

To lead Abeona’s commercial organization, EB-101 commercialization planning and pre-commercial strategy for AAV-based gene therapy programs To lead Abeona’s commercial organization, EB-101 commercialization planning and pre-commercial strategy for AAV-based gene therapy programs

Abeona Therapeutics Announces Appointment of Michael Amoroso as Chief Commercial Officer

NEW YORK and CLEVELAND, July  08, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced recent updates on its clinical programs, highlighted by the restart of patient enrollment in the Company’s pivotal Phase 3 VIITAL™ study of EB-101, its autologous, gene-corrected cell therapy, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Enrollment in the VIITAL™ study at Stanford University Medical Center was paused in March 2020 in order to redirect healthcare resources to COVID-19 patients and to ensure the safety of study participants and site staff.

Abeona Therapeutics Reinitiates Enrollment in EB-101 Pivotal Phase 3 VIITAL™ Study in RDEB after COVID-19 Related Pause and Announces Progress in Patient Enrollment in MPS III Studies

NEW YORK and CLEVELAND, June  18, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that two abstracts related to its clinical program for recessive dystrophic epidermolysis bullosa (RDEB) will be presented at the upcoming Society for Pediatric Dermatology (SPD) 45th Annual Meeting, to be held virtually during July 10-12, 2020. RDEB is a rare connective tissue disorder without an approved treatment, in which patients suffer from severe epidermal wounds that severely impact their lives.

Abeona Therapeutics Announces Upcoming Data Presentations at the Society for Pediatric Dermatology 45th Annual Meeting

NEW YORK and CLEVELAND, June  17, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced Board of Director appointments that strengthen and expand the Company’s leadership. George Migausky and Paul Mann were appointed as independent directors, effective June 17, 2020. In addition to their Board service, Mr. Migausky will serve as Chairman of the Company's Audit Committee and Mr. Mann will serve as a member of the Audit Committee.

Abeona Therapeutics Further Strengthens Board with Appointment of Two New Independent Directors

Is  (ABEO) Outperforming Other Medical Stocks This Year?

Is Abeona Therapeutics (ABEO) Outperforming Other Medical Stocks This Year?

Abeona Therapeutics is looking like an interesting pick from a technical perspective, as the company is seeing favorable trends on the moving average crossover front

Moving Average Crossover Alert: Abeona Therapeutics

Abeona's (ABEO) operating expenses are expected to have increased in the first quarter driven by clinical studies on its lead gene therapy candidate.

Is a Beat in Store for Abeona (ABEO) This Earnings Season?

NEW YORK and CLEVELAND, April  21, 2020  (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced it granted options to Brian Pereira, M.D., the newly-appointed Executive Chairman of the Company, to purchase 930,000 shares of Abeona common stock. The stock options have a $2.50 exercise price per share, which is equal to the closing price of Abeona's common stock on the grant date. The options were offered as a material inducement to Dr. Pereira’s appointment as Executive Chairman.

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