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.

Abeona Therapeutics Inc (NASDAQ: ABEO) has completed a Type B meeting with the FDA regarding the pivotal trial for its ABO-102 gene therapy for Sanfilippo syndrome type A (MPS IIIA).  ABO-102 is currently being evaluated in the single-arm Transpher A study in patients with MPS IIIA.

Abeona Stock Gains As It Concludes Type B Meeting With FDA For MPS IIIA Gene Therapy

Transpher A; pivotal study for intended registration of ABO-102 for MPS IIIA disease

Abeona Therapeutics Announces Successful Type B Meeting with U.S. FDA for ABO-102 AAV-based Gene Therapy in Sanfilippo Syndrome Type A (MPS IIIA)

Abeona Therapeutics Inc (NASDAQ: ABEO) announced magnetic resonance imaging (MRI) data from the Phase 1/2 Transpher A study of ABO-102 gene therapy in Sanfilippo Syndrome Type A (MPS IIIA). Data indicated that ABO-102 increased grey matter, corpus callosum, and amygdala volumes in the brain in three young patients at 24 months as compared to afflicted patients without treatment.

Abeona Stock Moves Higher After MPS IIIA Gene Therapy Shows Increase In Brain Volume

New data from Phase 1/2 Transpher A study presented at 16th International Symposium on MPS and Related Diseases New data from Phase 1/2 Transpher A study presented at 16th International Symposium on MPS and Related Diseases

Abeona Therapeutics Announces New MRI Data Showing Increased Brain Volume in Young Patients with Sanfilippo Syndrome Type A (MPS IIIA) After Treatment with ABO-102 Gene Therapy

NEW YORK and CLEVELAND, July 23, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the activation of a second clinical trial site in its pivotal Phase 3 VIITAL™ study of its investigational EB-101 treatment for recessive dystrophic epidermolysis bullosa (RDEB) at UMass Memorial Medical Center in Worcester, MA.

Abeona Therapeutics Activates Second Clinical Trial Site in EB-101 Pivotal Phase 3 VIITAL™ Study for Recessive Dystrophic Epidermolysis Bullosa

Abeona Therapeutics Inc (NASDAQ: ABEO) has announced updated data from Phase 1/2a trial for up to six years following treatment with EB-101 for recessive dystrophic epidermolysis bullosa (RDEB).  The data showed that investigator assessment of wound healing of over 50% from baseline was present in 69% of treated wounds (n=18/26) at three years, 93% (n=14/15) at four years, 80% (n=12/15) at five years, and 80% (n=4/5) at six years.

Abeona Unveils Additional Data From Gene Therapy Trial For Rare Connective Tissue Disorder

NEW YORK and CLEVELAND, July 07, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced updated Phase 1/2a clinical trial results up to six years following treatment with Abeona's investigational EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The data showed that investigator assessment of wound healing of 50% or greater from baseline was present in 69% of treated wounds (n=18/26) at 3 years, 93% (n=14/15) at 4 years, 80% (n=12/15) at 5 years, and 80% (n=4/5) at 6 years. The results were reported in a poster, titled “Long-Term Healing, Pain Reduction, and Patient-Reported Outcomes in Recessive Dystrophic Epidermolysis Bullosa Following EB-101 Treatment of Large, Chronic Wounds,” at the Society for Pediatric Dermatology (SPD) 46th Annual Meeting.

Abeona Therapeutics Announces Updated EB-101 Phase 1/2a Clinical Results in Recessive Dystrophic Epidermolysis Bullosa at the Society for Pediatric Dermatology 46th Annual Meeting

NEW YORK and CLEVELAND, June 02, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that Michael Amoroso, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 10:30 a.m. ET.

Abeona Therapeutics to Present at Jefferies Virtual Healthcare Conference

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NEW YORK and CLEVELAND, May 26, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today issued the following letter to stockholders in conjunction with the 2021 Abeona Therapeutics Annual Meeting of Stockholders to be held today, May 26, 2021:

Abeona Therapeutics Issues Letter to Stockholders

Abeona Therapeutics Inc. (ABEO) CEO Michael Amoroso on Q1 2021 Results - Earnings Call Transcript

NEW YORK and CLEVELAND, May 25, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Vishwas Seshadri, Ph.D., M.B.A., as Senior Vice President, Head of Research & Clinical Development, effective June 1, 2021. Dr. Seshadri joins the company from Celgene Corporation, now a subsidiary of Bristol-Myers Squibb Company (BMS), and brings more than 20 years of experience including in academia and various senior and executive leadership roles in the life sciences industry overseeing product development, regulatory submissions, and commercialization for novel therapies including personalized, autologous cell therapies.

Abeona Therapeutics Appoints Head of Research & Clinical Development

Patient enrollment ongoing for EB-101 pivotal Phase 3 VIITAL™ study

Abeona Therapeutics Reports First Quarter Financial Results

Abeona Therapeutics (ABEO) could be a stock to avoid from a technical perspective, as the firm is seeing unfavorable trends on the moving average crossover front

Moving Average Crossover Alert: Abeona Therapeutics (ABEO)

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NEW YORK and CLEVELAND, April 20, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that new data from its preclinical research will be highlighted during an oral presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting, being held virtually from May 1-7, 2021.

Abeona Therapeutics Announces Presentation on New Preclinical Data Supporting the Potential of Cre-Mediated Dual AAV Vector Technology to Enable Delivery of Large Genes Targeted for Treatment of Stargardt Disease at ARVO 2021 Annual Meeting

New board members add a wealth of experience in clinical development and manufacturing of cell therapy and gene therapy products New board members add a wealth of experience in clinical development and manufacturing of cell therapy and gene therapy products

Abeona Therapeutics Appoints Two Industry Leaders as New Independent Members to Its Board of Directors

Abeona Therapeutics Inc. (ABEO) CEO Michael Amoroso on Q4 2020 Results - Earnings Call Transcript

Refreshed board to bring fresh perspectives, relevant expertise and diverse experience Refreshed board to bring fresh perspectives, relevant expertise and diverse experience

Abeona Therapeutics Announces Appointment of Two New Independent Members to its Board of Directors

Abeona Therapeutics (ABEO) delivered earnings and revenue surprises of -88.89% and -45.95%, respectively, for the quarter ended December 2020. Do the numbers hold clues to what lies ahead for the stock?

Abeona Therapeutics (ABEO) Reports Q4 Loss, Lags Revenue Estimates

Fourth patient treated in pivotal Phase 3 VIITAL™ study of EB-101 in RDEB after successful Type B meeting with FDA

Abeona Therapeutics Announces 2020 Financial Results and Recent Operational Progress

NEW YORK, March 23, 2021 /PRNewswire/ -- Purcell Julie & Lefkowitz LLP, a class action law firm dedicated to representing shareholders nationwide, is investigating a potential breach of fiduciary duty claim involving the board of directors of Abeona Therapeutics Inc. (NASDAQ: ABEO). If you are a shareholder of Abeona Therapeutics Inc. and are interested in obtaining additional information regarding this investigation, free of charge, please visit us at: http://pjlfirm.com/abeona-therapeutics-inc/ You may also contact Robert H.

SHAREHOLDER ALERT: Purcell Julie & Lefkowitz LLP Is Investigating Abeona Therapeutics Inc. for Potential Breaches Of Fiduciary Duty By Its Board of Directors

CEO appointment provides continuity and reflects company's demonstrated strong operational performance CEO appointment provides continuity and reflects company's demonstrated strong operational performance

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