Abeona Therapeut Stock Price, News & Analysis

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.

Abeona Therapeutics Inc. (Nasdaq: ABEO) has activated a second clinical trial site at UMass Memorial Medical Center for its Phase 3 VIITAL™ study of the investigational EB-101 treatment for recessive dystrophic epidermolysis bullosa (RDEB). The study aims to enroll 10 to 15 patients and will assess the treatment's efficacy in healing wounds and reducing pain associated with dressing changes. EB-101 delivers a functional COL7A1 gene to patients' skin cells to facilitate wound healing. The study is vital as RDEB currently lacks approved therapies.

Abeona Therapeutics announced updated Phase 1/2a clinical trial results for EB-101, an investigational treatment for recessive dystrophic epidermolysis bullosa (RDEB). Results showed significant long-term wound healing, with 69% of treated wounds achieving 50% healing at 3 years, 93% at 4 years, and 80% at both 5 and 6 years follow-ups. Pain assessments indicated absence of pain in treated wounds compared to 53% at baseline. Abeona is progressing to a Phase 3 VIITAL™ study, indicating confidence in EB-101's potential to address chronic wounds in RDEB patients.