Business
Abeona Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update
Expects to submit BLA for EB-101 to FDA in late-2Q/early-3Q 2023 based on positive Phase 3 VIITAL™ study results announced in 4Q 2022 Advancing AAV-based gene
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"Expects to submit BLA for EB-101 to FDA in late-2Q/early-3Q 2023 based on positive Phase 3 VIITAL™ study results announced in 4Q 2022 Advancing AAV-based gene therapy candidates toward IND studies in Stargardt Disease, X-linked Retinoschisis, and Autosomal Dominant Optic Atrophy Strengthened senior management team with executive appointments and promotions NEW YORK and CLEVELAND, March 29, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the full year of 2022 and provided an update on progress toward achieving key corporate objectives. The Company will host a conference call and webcast today, March 29, 2023, at 8:30 a.m. ET, to discuss its financial results and business update. “Since announcing positive topline results for the Phase 3 VIITAL study late last year, we have had multiple recent collaborative interactions with the FDA, and are continuing to work diligently toward completing and submitting our Biologics License Application for EB-101 in recessive dystrophic epidermolysis bullosa (RDEB),” said Vish Seshadri, Chief Executive Officer of Abeona. “We believe the VIITAL study results highlight the value that EB-101 could bring to RDEB patients as does the encouraging feedback we have received from our initial interactions with payors. In addition, we continue to make progress in our earlier stage programs that have the potential for treating serious eye diseases with new adeno-associated virus-based gene therapies, and we expect to keep advancing these toward an Investigational New Drug filing and clinical trials.” Fourth Quarter and Recent Operating Highlights, and Upcoming Events EB-101 for recessive dystrophic epidermolysis bullosa (RDEB) In November 2022, Abeona announced positive topline results with both co-primary endpoints and all other endpoints met in the pivotal Phase 3 VIITAL study of investigational EB-101 in RDEB. Additional data from the VIITAL study has been accepted for an oral presentation at the International Societies for Investigative Dermatology (ISID) Meeting in May 2023. Furthermore, durability of EB-101 clinical outcomes was published in the Orphanet Journal of Rare Diseases, demonstrating sustained wound healing with a mean follow up of 5.9 years and symptomatic relief based on long term follow up of the Phase 1/2a study.Abeona continues to mak...