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 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.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced two abstracts for its clinical program on recessive dystrophic epidermolysis bullosa (RDEB) will be presented at the Society for Pediatric Dermatology's Annual Meeting from July 10-12, 2020. RDEB is a rare disorder causing severe skin wounds, with no approved treatments available. The first abstract discusses long-term pain relief from EB-101 treatment, while the second reviews the overall burden of RDEB. Presenters include Stanford University’s Jean Tang and M. Peter Marinkovich. Detailed information will be accessible on Abeona's website post-event.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the appointment of George Migausky and Paul Mann as independent directors, effective June 17, 2020. Migausky will also serve as Chairman of the Audit Committee, enhancing the company’s governance. With over 30 years of experience in financial management and strong backgrounds in biotechnology, both directors will contribute to the advancement of Abeona's gene and cell therapies. Notable projects include EB-101, in Phase 3 development, and ABO-102 and ABO-101 for Sanfilippo syndrome, aimed at addressing urgent medical needs.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that its CEO, João Siffert, M.D., will present at the Jefferies Virtual Healthcare Conference on June 4, 2020, at 10:00 a.m. ET. The live webcast can be accessed on the company's investor website, with a replay available within 24 hours for 90 days. Abeona focuses on gene and cell therapies for serious diseases, including EB-101 for epidermolysis bullosa and AAV-based therapies for Sanfilippo syndrome. The company has received multiple regulatory designations from the FDA and EMA, signaling its innovative pipeline.
Abeona Therapeutics (ABEO) announced key developments in its clinical programs, including the first patient treated in the Phase 3 VIITAL™ study for EB-101, targeting recessive dystrophic epidermolysis bullosa. The company also reported positive interim data on gene therapies for MPS IIIA and MPS IIIB at WORLDSymposium™, highlighting improvements in neurocognitive skills and disease-specific biomarkers. Financially, Abeona reported a net loss of $0.52 per share for Q1 2020, influenced by a $32.9 million impairment charge. The company appointed new executives to strengthen its leadership team.