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) 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.
Abeona Therapeutics (ABEO) reported significant progress in Q1 2021, focusing on gene therapies for rare diseases. Notable highlights include ongoing patient enrollment in the pivotal Phase 3 VIITAL™ study for EB-101, expected to complete in 2021, and positive interim data for ABO-102 and ABO-101 presented at the WORLDSymposium. The company also strengthened its leadership team, enhancing corporate governance. Financially, Abeona's cash reserves decreased to $86.8 million, with a net loss of $16 million, significantly lower than the previous year's loss. A conference call is scheduled for May 25, 2021, to discuss results.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced new preclinical data to be presented at the ARVO 2021 Annual Meeting, highlighting a dual AAV vector strategy to treat Stargardt disease, caused by ABCA4 gene mutations. The data shows potential for effective gene reconstitution, which may lead to full-size ABCA4 protein expression. This study could influence future clinical development plans. The oral presentation will occur on May 4, 2021, focused on gene therapy for ocular diseases, underlining Abeona's commitment to advanced gene and cell therapies.
Abeona Therapeutics has appointed Dr. Leila Alland and Mr. Donald Wuchterl as independent board members. This strategic addition aims to enhance the company's focus on gene and cell therapies. They bring extensive experience in clinical development, manufacturing, and biologics. Dr. Alland has a notable background in oncology and previously worked with major pharmaceutical companies, while Mr. Wuchterl has over 29 years in life sciences, particularly in GMP manufacturing. Their expertise is expected to guide Abeona's corporate strategy and operational execution as the company progresses in developing therapies for serious diseases.
Abeona Therapeutics has announced the addition of two new independent members, Faith L. Charles and Mark Alvino, to its Board of Directors, enhancing its leadership with significant biotechnology expertise. Charles, a partner at Thompson Hine, has extensive experience in corporate transactions and life sciences. Alvino, President at Hudson Square Capital, brings over 25 years of financial and strategic insight. The company aims to leverage this new board composition to drive growth, improve governance, and increase shareholder value in the competitive gene and cell therapy industry.
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.