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 commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, with a primary focus on recessive dystrophic epidermolysis bullosa (RDEB)ZEVASKYN® (prademagene zamikeracel), which Abeona describes as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB.
On this page, readers can follow ABEO news related to ZEVASKYN’s commercial rollout, including activation of new Qualified Treatment Centers, initial patient treatments, and updates on manufacturing and product release processes at the company’s cell and gene therapy cGMP facility in Cleveland, Ohio. Press releases also cover developments in reimbursement and market access, such as the assignment of a permanent HCPCS J-code (J3389) by the Centers for Medicare and Medicaid Services (CMS) and coverage decisions by commercial health plans.
Abeona’s news flow additionally features corporate and pipeline updates, including quarterly financial results, participation in investor conferences, and progress in its AAV-based gene therapy programs, such as the ABO-503 program for X-linked retinoschisis (XLRS) selected for the FDA’s Rare Disease Endpoint Advancement Pilot Program. Management appointments and employee equity inducement grants under Nasdaq Listing Rule 5635(c)(4) are also regular topics.
Investors, clinicians, and other stakeholders can use this ABEO news feed to review the company’s latest disclosures on commercial performance indicators, regulatory and payer milestones, treatment site expansion, and strategic pipeline initiatives in gene therapy.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported Q3 2021 results and progress on key projects. The Phase 3 VIITAL™ study for EB-101 is on track to finish patient enrollment in Q1 2022, with top-line data expected by Q3 2022. The company anticipates submitting Biologics License Applications (BLA) for both EB-101 and ABO-102 in late 2022 to early 2023. A settlement with REGENXBIO has been reached, resolving a dispute and allowing resource focus on pipeline advancement. As of September 30, 2021, cash was $67 million, with a net loss of $7 million for the quarter.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that CEO Vish Seshadri, Ph.D., M.B.A., will present at the Jefferies Gene Therapy/Editing Summit on October 27, 2021, at 3:30 p.m. ET. The presentation will be available live and archived on the company’s investor website. Abeona is focused on gene and cell therapies for serious diseases, with key projects including the Phase 3 autologous gene-corrected therapy EB-101 for epidermolysis bullosa, and AAV-based therapies for Sanfilippo syndrome types A and B, currently in Phase 1/2 development.
Abeona Therapeutics (Nasdaq: ABEO) announced two upcoming presentations of clinical data at scientific congresses in October 2021. The first presentation will showcase long-term wound healing and pain relief data from the Phase 1/2a EB-101 trial at the PeDRA Annual Conference on October 14-15, 2021. The second presentation will discuss interim results from the pivotal trial of investigational gene therapy ABO-102 in MPS IIIA at the ESGCT Congress from October 19-22, 2021. These events highlight Abeona's advancements in gene therapy for rare diseases.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the appointment of Jon Voss as Vice President, Head of Quality. Voss, previously a consultant, brings over 30 years of quality experience in gene therapy and biopharmaceuticals, having held senior roles at Cellectis, Sarepta Therapeutics, and Genzyme. His leadership is expected to enhance Abeona’s quality processes as the company prepares for two Biologics License Application submissions for its therapies, EB-101 and ABO-102, currently in pivotal studies.
Abeona Therapeutics Inc. announced significant leadership changes, including the retirement of Steven Rouhandeh as Chairman and the appointment of Michael Amoroso as his successor, effective October 15, 2021. Dr. Vishwas Seshadri will become CEO on the same date, enhancing leadership direction as the company prepares for Biologics License Application submissions for its gene therapies, EB-101 and ABO-102. Additional promotions within the executive team include Brendan O'Malley as General Counsel and Brian Kevany as Chief Technical Officer, among others, to support growth and operational capacity.
Abeona Therapeutics, a leader in gene and cell therapy, announced participation in several virtual investor conferences. Key events include Citi’s 16th Annual BioPharma Virtual Conference (Sept. 8-10), H.C. Wainwright 23rd Annual Global Investment Conference (Sept. 13-15), SVB Leerink CybeRx Series (Sept. 22-23), and Cantor Fitzgerald Virtual Global Healthcare Conference (Sept. 30). Presentations will be available on their website, with webcasts accessible for 90 days post-event. Notable products in development include EB-101 for recessive dystrophic epidermolysis bullosa and AAV-based gene therapies for Sanfilippo syndrome.
Abeona Therapeutics (Nasdaq: ABEO) appointed Edward Carr as Chief Financial Officer, effective immediately. Carr has been with the company since 2018, serving as Chief Accounting Officer. The company's CEO, Michael Amoroso, expressed confidence in Carr’s leadership to drive clinical and regulatory goals while enhancing long-term success. Abeona is focused on gene and cell therapies, with clinical programs including EB-101 for epidermolysis bullosa in Phase 3, and AAV-based therapies for Sanfilippo syndrome in Phase 1/2.
Abeona Therapeutics (ABEO) announced significant advancements in its clinical trials during Q2 2021. The company activated its second clinical trial site for the pivotal Phase 3 VIITAL™ study of EB-101, an autologous gene therapy for RDEB. They reported promising results, showing considerable pain reduction in chronic wounds. Additionally, Abeona had a successful Type B meeting with the FDA for ABO-102, intended to treat MPS IIIA, leading to a pivotal study that may support a BLA filing. Financially, Abeona reported a net loss of $15.2 million and reduced G&A expenses to $5.5 million.
Abeona Therapeutics (Nasdaq: ABEO) announced a successful Type B meeting with the FDA regarding its pivotal trial for ABO-102, aimed at treating MPS IIIA patients. The ongoing Transpher A study is set to support a Biologics License Application, contingent on data collected. The FDA and Abeona aligned on key study endpoints, focusing on neurocognitive assessments. The company has treated 21 patients thus far and remains optimistic about the safety and effectiveness of ABO-102, particularly in younger children. Abeona plans to deliver two pivotal data packages in 2022.
Abeona Therapeutics (Nasdaq: ABEO) has presented new MRI data from its Phase 1/2 Transpher A study at the 16th International Symposium on MPS and Related Diseases. This data shows that ABO-102 significantly increased brain volumes in young patients suffering from Sanfilippo Syndrome Type A (MPS IIIA) compared to untreated peers over 24 months. The study indicates potential benefits in neurocognitive development, with primary endpoints focusing on neurodevelopment and safety.