Business
Abeona Therapeutics Reports Second Quarter Financial Results and Business Updates
Additional patients dosed in RDEB, MPS IIIA and MPS IIIB clinical programs General alignment with CHMP on plans for EU registration of ABO-102 for MPS IIIA
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"Additional patients dosed in RDEB, MPS IIIA and MPS IIIB clinical programs\n General alignment with CHMP on plans for EU registration of ABO-102 for MPS IIIA Data from RDEB and MPS III programs presented at recent medical meetings Strengthened leadership team with appointment of experienced Chief Commercial Officer and two independent Board members Conference call on Tuesday, August 11, 2020 at 8:30 a.m. ET NEW YORK and CLEVELAND, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced financial results for the second quarter 2020 and recent business progress. “During the past several months, Abeona has delivered on our goals in clinical development, manufacturing, and regulatory affairs toward bringing urgently needed treatments to patients with RDEB and MPS III,” said João Siffert, M.D., Chief Executive Officer of Abeona. “Notably, new patients have been treated in our RDEB and MPS IIIA clinical programs, and we expect additional patient enrollment across our clinical programs in the coming weeks. Concurrent with the increased clinical activities, we resumed internal manufacturing operations at our Cleveland campus in June. We have made significant advancements in process development for retrovirus and AAV manufacturing in-house, anticipated to start in late-2020 and early-2021, respectively. In addition, we recently reached general alignment with the CHMP on our proposed path toward a European marketing authorization application for ABO-102 in MPS IIIA, anticipated in 2023. Looking ahead to the potential commercial launches of EB-101 in late-2022 and ABO-102 the following year, we have also strengthened our leadership team, bringing on board a Chief Commercial Officer with significant relevant experience and expertise.” Second Quarter and Recent Highlights EB-101 (Autologous, Gene-Corrected Cell Therapy) A second patient was treated in Abeona’s EB-101 pivotal Phase 3 VIITAL™ study for recessive dystrophic epidermolysis bullosa (RDEB) after enrollment resumed in June 2020 following a pause due to the COVID-19 pandemic. Additional patients are expected to be treated in the coming weeks, with completion of enrollment in the VIITAL study expected in early-2021.Two posters were presented at the Society for Pediatric Dermatology 45th Annual Meeti...