Welcome to our dedicated page for Abeona Therapeut news (Ticker: ABEO), a resource for investors and traders seeking the latest updates and insights on Abeona Therapeut stock.
Abeona Therapeutics Inc (NASDAQ: ABEO) is a clinical-stage biopharmaceutical leader advancing gene therapies for rare genetic diseases. This dedicated news hub provides investors and researchers with essential updates on ABEO’s therapeutic developments, regulatory milestones, and scientific partnerships.
Discover timely press releases detailing progress in AAV-based therapies, CRISPR/Cas9 research, and pivotal clinical trials for conditions like epidermolysis bullosa. Our curated collection includes FDA correspondence updates, manufacturing quality certifications, and strategic collaboration announcements – all critical for evaluating the company’s trajectory.
Key content categories feature BLA submission statuses, Phase 3 trial results, and technology licensing agreements. Bookmark this page for streamlined access to verified updates about ABEO’s pipeline candidates and operational developments, presented with clarity for both professional analysts and engaged stakeholders.
Abeona Therapeutics announced updates on its clinical programs and financial results for Q4 and full year 2020. The pivotal Phase 3 VIITAL study of EB-101 for RDEB has treated its fourth patient, following a successful Type B meeting with the FDA on endpoints. Interim data from MPS IIIA and IIIB programs showed promising results, with 19 patients dosed in the ABO-102 study. As of December 31, 2020, cash reserves totaled $95 million. The net loss for 2020 was $84.2 million, impacted by a non-cash impairment charge. A conference call is scheduled for March 25, 2021.
Abeona Therapeutics Inc. has appointed Michael Amoroso as its new CEO, following his role as COO. This transition is aimed at ensuring continuity and reflects the company's strong operational performance. During his time as COO, Amoroso oversaw key aspects including research and clinical development, leading to significant milestones in Abeona's clinical programs. The company is focused on developing innovative gene and cell therapies for serious diseases, including ongoing trials for treatment options aimed at rare conditions.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced its participation in the 10th Annual SVB Leerink Global Healthcare Conference on February 24, 2021, at 11:20 am EST. A live webcast of the presentation will be accessible on the company's investor website, with an archived replay available for 30 days. Abeona is focused on developing gene and cell therapies for serious diseases, with key programs including EB-101 for epidermolysis bullosa and AAV-based therapies for Sanfilippo syndrome. Their GMP facility supports the production of these therapies.
Abeona Therapeutics announced new positive data from ongoing Phase 1/2 trials for ABO-102 and ABO-101, treating MPS IIIA and MPS IIIB. Notably, ABO-102 preserved neurocognitive development in young patients for 2.5 to 3 years post-treatment, with dose-dependent reductions in biomarkers. Both therapies demonstrated favorable safety profiles, without severe adverse events reported. The company plans to discuss data with the FDA to explore the potential for a Biologics License Application for ABO-102. An investor webinar is scheduled for February 16, 2021.
Abeona Therapeutics has successfully completed a Type B meeting with the FDA regarding the co-primary endpoints for the Phase 3 VIITAL™ study of EB-101, a treatment for recessive dystrophic epidermolysis bullosa (RDEB). The study aims to enroll 10-15 patients with over 35 chronic wound sites. The co-primary endpoints include a 50% healing threshold and pain reduction upon wound dressing changes, evaluated at Week 24. Previous trials showed durable wound healing effects with no pain at treated sites lasting 2-5 years. The company is preparing for patient enrollment in 2021.
Abeona Therapeutics (Nasdaq: ABEO) announced interim results from its ABO-102 and ABO-101 Phase 1/2 studies for MPS IIIA and MPS IIIB, respectively. These results will be presented at the 17th Annual WORLD Symposium on February 12, 2021. The Transpher A study focuses on ABO-102's ability to preserve neurocognitive development in young patients, while Transpher B will provide insights into ABO-101's effects. Both therapies target rare lysosomal storage diseases with no approved treatments. Abeona holds multiple designations from regulatory agencies for these therapies.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported its third quarter 2020 financial results, highlighting a net loss of $7.2 million, down from a $17.4 million loss in Q3 2019. The company received $7 million from licensing agreements with Taysha Gene Therapies for ABO-202 and $3 million for Rett syndrome gene therapy. R&D expenses decreased to $8 million due to COVID-19 impacts. Abeona continues clinical trials for RDEB and MPS IIIA/B, aiming for regulatory submissions in 2021. Cash reserves were $103.9 million as of September 30, 2020.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the promotion of Michael Amoroso to Chief Operating Officer, effective November 1, 2020. This newly created role expands his oversight to include all company operations, encompassing research, clinical development, and business strategies. Amoroso brings over 20 years of experience in biotechnology, previously holding senior positions at Kite and Celgene. The company's focus remains on advancing significant clinical programs for rare diseases, including pivotal studies for recessive dystrophic epidermolysis bullosa and Sanfilippo syndrome.
Abeona Therapeutics Inc. (NASDAQ: ABEO) has appointed Steven H. Rouhandeh as Chairman of its Board of Directors. The company has also established a Special Committee to guide executive leadership on operations and strategic direction, working closely with its team to advance gene and cell therapies. In addition, Abeona has engaged Jefferies LLC as a financial advisor to explore strategic options to enhance stakeholder value, with no specific timeline for this review. The company is known for its innovative clinical programs focusing on serious diseases and aims to maximize its mission.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced significant changes in its leadership and Board of Directors on September 28, 2020. João Siffert, M.D. resigned as CEO and other key positions on September 23, followed by the resignation of five Board members on September 27. The company is now exploring various strategic options, including potential asset sales, though no specific timelines or outcomes are guaranteed. Abeona is focused on developing gene and cell therapies for serious diseases, with several clinical programs underway, including EB-101, ABO-101, and ABO-102.
