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) 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.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported significant changes in its leadership as CEO João Siffert, M.D. resigned, along with several board members on September 23 and 27, 2020. The company is now evaluating strategic options, including potential asset sales, although no specific timeline or outcomes are guaranteed. Abeona specializes in gene and cell therapies for serious diseases, with ongoing clinical programs in Phase 1/2 and Phase 3 development. The company highlights its AAV-based gene therapies and GMP manufacturing capabilities, essential for its clinical trials.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced its participation in key investor conferences in September 2020. CEO João Siffert will engage in virtual one-on-one meetings at Citi’s 15th Annual BioPharma Virtual Conference on September 9. Additionally, he will present at the Wells Fargo Virtual Healthcare Conference on September 10 at 10:00 a.m. ET, with a live webcast available on Abeona’s website. Abeona focuses on gene and cell therapies for serious diseases, including programs for recessive dystrophic epidermolysis bullosa and Sanfilippo syndrome.
Abeona Therapeutics Inc. (Nasdaq: ABEO) and Taysha Gene Therapies have entered into agreements for the licensing and purchase of inventory related to ABO-202, a gene therapy for CLN1 disease, also known as infantile Batten disease. Taysha will pay Abeona $7 million upfront, plus potential milestone payments up to $56 million and royalties on sales. The therapy aims to deliver a functional copy of the PPT1 gene, addressing a critical unmet medical need. Abeona will focus on advancing its other clinical programs post-agreement.
Abeona Therapeutics (Nasdaq: ABEO) reported significant clinical advancements and financial results for Q2 2020. The firm resumed patient enrollment in pivotal studies for RDEB and MPS IIIA, with new patients treated in both programs. Abeona aims for a 2023 EU marketing application for ABO-102 and anticipates commercial launches of EB-101 in late-2022. Financially, the company held $107.9 million in cash, with a net loss of $13 million for Q2. Leadership strengthened with a new Chief Commercial Officer and board members, enhancing strategic direction.
Abeona Therapeutics announced results from two poster presentations at the Society for Pediatric Dermatology's Annual Meeting regarding its EB-101 treatment for recessive dystrophic epidermolysis bullosa (RDEB). The data revealed that EB-101 treatment led to significant and durable healing of large, chronic wounds, resulting in long-term pain relief lasting up to five years. Additionally, a literature review of 65 studies highlighted the substantial clinical, economic, and humanistic burden associated with RDEB, affecting patients and their families.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced Michael Amoroso as the new Senior Vice President and Chief Commercial Officer, effective immediately. With over 20 years of experience in biotechnology and pharmaceuticals, Amoroso aims to lead the company's commercial strategies for its gene therapies, including the pivotal Phase 3 study of EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). His previous roles at Kite and other major firms equip him with expertise in product commercialization, essential for Abeona’s growth and market strategy.
Abeona Therapeutics (Nasdaq: ABEO) announced the resumption of patient enrollment in the pivotal Phase 3 VIITAL™ study of EB-101, a gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). Enrollment was paused due to COVID-19, impacting healthcare resources.
Additionally, the ongoing MPS III Phase 1/2 clinical trials for gene therapies ABO-102 and ABO-101 continue to treat patients, with recent dosing updates. Abeona’s gene therapies address critical unmet needs in rare diseases, with EB-101 showing durable wound healing from a previous Phase 1/2 trial.
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