Abeona Therapeutics Inc. - ABEO STOCK NEWS

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.

Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that CEO Michael Amoroso will present at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 10:30 a.m. ET. A live and archived webcast of this presentation will be accessible on the company's investor website. Abeona is focused on developing gene and cell therapies for serious diseases, with clinical programs including EB-101 for epidermolysis bullosa and AAV-based therapies for Sanfilippo syndrome. The company operates a cGMP facility for the production of these therapies, which are critical for its ongoing and future clinical studies.

Abeona Therapeutics Inc. (Nasdaq: ABEO) held its 2021 Annual Meeting of Stockholders on May 26, 2021, highlighting progress in developing gene and cell therapies for rare diseases, specifically recessive dystrophic epidermolysis bullosa (RDEB) and Sanfilippo syndrome. Significant milestones include the initiation of the Phase 3 VIITAL™ study of EB-101, showing durable healing in prior trials, and promising interim data for ABO-102 in preserving neurocognitive function. The company is focused on completing clinical enrollment, enhancing regulatory pathways, and expanding its manufacturing capabilities.

Abeona Therapeutics Inc. (Nasdaq: ABEO) has appointed Vishwas Seshadri, Ph.D., M.B.A., as Senior Vice President and Head of Research & Clinical Development, effective June 1, 2021. Dr. Seshadri brings over 20 years of experience in the life sciences industry, previously serving at Celgene (BMS). He will lead Abeona's research and clinical programs, overseeing preclinical efforts and regulatory strategy. Notably, the company anticipates a Type B meeting with the FDA in June 2021 regarding the ABO-102 study, which could pave the way for a Biologics License Application for MPS IIIA.