Business
Abeona Therapeutics Reports First Quarter 2023 Financial Results
Continues to make progress toward Biologics License Application (BLA) submission for EB-101 in late-2Q/early-3Q 2023; submitted request for pre-BLA meeting
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"Continues to make progress toward Biologics License Application (BLA) submission for EB-101 in late-2Q/early-3Q 2023; submitted request for pre-BLA meeting Additional Phase 3 VIITAL™ study results presented at International Societies for Investigative Dermatology 2023 Meeting further highlights EB-101 value proposition in RDEB Multiple presentations on animal proof-of-concept data from its AAV ophthalmology program at upcoming 26th Annual Meeting of American Society of Gene & Cell Therapy Reiterates cash runway guidance into 3Q 2024, beyond anticipated timing for EB-101 BLA potential approval CLEVELAND, May 11, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2023 and provided an update on progress toward achieving key corporate objectives. “We remain focused on completing our EB-101 Biologics License Application for recessive dystrophic epidermolysis bullosa (RDEB) and are making good progress towards this goal,” said Vish Seshadri, Chief Executive Officer of Abeona. “We are also excited to be presenting encouraging results from animal proof-of-concept studies from our AAV ophthalmology program at the ASGCT annual meeting next week.” First Quarter and Recent Portfolio Update EB-101 for RDEB Abeona continues to make progress toward submitting a BLA for EB-101 to the U.S. Food and Drug Administration (FDA) in late second quarter to early third quarter of 2023. The Company has submitted a pre-BLA meeting request to the FDA in advance of the anticipated BLA submission. If the BLA is approved, Abeona anticipates being granted a Priority Review Voucher (PRV), which can be used to receive expedited review by the FDA of a subsequent marketing application for a different product or sold to another company.Abeona announced today in a separate press release that additional data from the pivotal Phase 3 VIITAL study of investigational EB-101 in RDEB was presented during an oral session at the International Societies for Investigative Dermatology (ISID) Meeting. The positive top-line efficacy and safety data from the VIITAL study was reported in November 2022.As part of its commercial planning, the Company continues to engage with stakeholders across the healthcare system, including public and private payors, and healthcare providers to better understand market access...