ABEO - Earnings announcements

- Three patients treated with ZEVASKYN® in Q1 2026 - - QTC network expands to six sites, with two new additions on the East Coast -  - In-licensed radically novel engineered T-cell technology with game changing potential in the field of solid tumors; ophthalmology programs deprioritized - - $168.3M in cash, cash equivalents and short-term investments as of March 31, 2026 - - Webcast today at 8:30am ET - CLEVELAND, May 13, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the first quarter of 2026, highlighting commercial momentum for ZEVASKYN. Steady increase in ZEVASKYN adoption with three patients completing treatment in the first

CLEVELAND, May 04, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it will host a conference call on Wednesday, May 13, 2026 at 8:30 a.m. ET to discuss its financial results for the first quarter of 2026 and corporate progress. The conference call will be available via phone and webcast. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 305519 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona's website at https://investors.abeonatherapeutics.com/events. The archived webcast replay will be avai

- First ZEVASKYN® commercial patient treatment completed in December - - ZEVASKYN launch momentum building in first quarter 2026 – - $191.4M in cash, cash equivalents and short-term investments as of December 31, 2025 - CLEVELAND, March 17, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the full year of 2025 and recent operational progress. "2026 is about building a steady cadence of biopsies and treatments," said Vish Seshadri, Chief Executive Officer of Abeona. "We are focused on ensuring every ZEVASKYN patient has a seamless experience throughout their treatment journey. Establishing these commercial foundations will position us

CLEVELAND, March 03, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it will host a conference call on Tuesday, March 17, 2026 at 8:30 a.m. ET to discuss its fourth quarter and full year 2025 financial results and corporate progress. The conference call will be available via phone and webcast. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 977217 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona's website at https://investors.abeonatherapeutics.com/events. The archived webcast replay will b

- First anticipated ZEVASKYN® patient treatment shifted to 4Q 2025 following implementation of optimized release assay - - Strong and growing patient demand and treatment site network, along with broad market access provide foundation for sustainable commercial success - - $207.5M in cash, cash equivalents, restricted cash and short-term investments as of September 30, 2025 expected to fund operations for over two years - CLEVELAND, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results and business highlights for the third quarter of 2025 and shared recent operational progress. "We are scaling the ZEVASKYN launch to meet patient needs

CLEVELAND, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it will host a conference call on Wednesday, November 12, 2025 at 8:30 a.m. ET to discuss its third quarter 2025 financial results and corporate progress. The conference call will be available via phone and webcast. To access the call, dial 877-545-0523 (U.S. toll-free) or 973-528-0016 (international) and Entry Code: 922481 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona's website at https://investors.abeonatherapeutics.com/events. The archived webcast replay will be available

- Received FDA approval for ZEVASKYN™ (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch on track and first ZEVASKYN patient treatment expected in 3Q 2025, momentum building with strong patient interest at qualified treatment centers and referrals, positive insurance coverage established with multiple national and regional payers - - $226M in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2025, expected to fund operations for over two years before accounting for anticipated ZEVASKYN revenue beginn

- Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adultand pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC) - - Entered into sales agreement for priority review voucher (PRV) for $155 million - CLEVELAND, May 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results and business highlights for the first quarter of 2025 and shared recent operational progress. "ZEVASKYN's appr

- ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure - - Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile - - ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025 - - Abeona Assist™ patient services program offers personalized support for eligible patients and families throughout their treatment journey with ZEVASKYN - - Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA - - Abeona Therapeutics® to host conference call today, Tuesday, April 29, 20

FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025 Launch preparations on track toward goal to treat first patient in 3Q 2025 CLEVELAND, March 20, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the full year of 2024, and announced progress in the ongoing review with the U.S. Food and Drug Administration (FDA) regarding prademagene zamikeracel (pz-cel) and plans for the U.S. commercial launch of pz-cel for recessive dystrophic epidermolysis bullosa (RDEB), if approved. The Company will host a conference call and webcast today at

FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commercialization of pz-cel in 2025; Builds momentum with payor discussions and target treatment centers CLEVELAND, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the third quarter ended September 30, 2024, and recent corporate updates. "With the acceptance of our Biologics License Application (BLA) resubmission for pz-cel, we are ramping up our commercial readiness efforts, especially with respect to onboarding potential pz-cel treatment

Significant progress addressing CMC items noted in CRL BLA resubmission remains on track for 2H 2024 CLEVELAND, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the second quarter of 2024 and recent corporate progress. "Having completed data generation for nearly all of the Chemistry Manufacturing and Controls deliverables outlined in the Complete Response Letter that we received in April 2024, we are on track to resubmit our Biologics License Application for pz-cel this year and, if approved, bring a treatment option to patients with recessive dystrophic epidermolysis bullosa," said Vish Seshadri, Chief Executive Offic

BLA resubmission anticipated in second half of 2024 Closed $75 million underwritten offering in May, extending expected cash runway into 2026 CLEVELAND, May 15, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the first quarter of 2024 and recent corporate progress. "We are grateful to our existing as well as new investors who have demonstrated their support through the recent financing, which has extended our cash runway into 2026, well beyond anticipated regulatory milestones," said Vish Seshadri, Chief Executive Officer of Abeona. "We now remain focused on working with the FDA to address the CMC deficiencies noted in the CRL and mak

Receives FDA Complete Response Letter (CRL) based on need for additional CMC information CRL did not identify deficiencies related to clinical efficacy or clinical safety data in BLA, and no new clinical studies requested by FDA to support approval Anticipates completing and submitting requested CMC information in 3Q 2024 Conference call and webcast on Tuesday, April 23, 2024 at 8:30 a.m. ET to provide details on the requested CMC information CLEVELAND, April 22, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced a regulatory update for prademagene zamikeracel (pz-cel). The U.S. Food and Drug Administration (FDA) has issued a Complete Response Lett

CLEVELAND, March 18, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the full year of 2023 and provided an update on progress toward achieving key corporate objectives. Abeona also announced today that the U.S. Food and Drug Administration (FDA) has completed a Pre-License Inspection (PLI) of its Cleveland, Ohio manufacturing facility related to the Company's Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB). During the inspection, the FDA reviewed the facilities, systems, and processes at the Cleveland site. The FDA also observed the manufacturing process for

CLEVELAND, May 22, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has changed the date of its previously announced First Quarter 2023 Portfolio Update conference call and webcast to Wednesday, May 24, 2023, at 8:30 a.m. ET. The call was previously scheduled for Tuesday, May 23, 2023, at 8:30 a.m. ET. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 885338 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona's website at www.abeonatherapeutics.com. The archived webcast replay will be availabl

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 repo

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

Co-primary endpoint measuring >50% wound healing, other endpoints measuring >75% and complete wound healing at six months all met Co-primary endpoint measuring pain reduction at six months met; greater magnitude of pain reduction benefit was observed in post-hoc analysis of EB-101 treated wounds with severe baseline pain EB-101 was well-tolerated with no serious treatment-related adverse events, consistent with past clinical experience Plans to submit Biologics License Application (BLA) to U.S. FDA Conference call on November 3, 2022 at 8:30 a.m. EDT NEW YORK and CLEVELAND, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced positive top

Disposition of MPS programs allows Abeona to extend runway of current cash into 2Q 2023 Phase 3 VIITAL™ study topline data expected in late-3Q/early-4Q 2022 upon completion of final patient monitoring visit in mid-September Baseline wound characteristics in VIITAL™ reveal significant scope for pain reduction and EB-101 differentiation NEW YORK and CLEVELAND, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in cell and gene therapy, today announced financial results for the second quarter of 2022. The Company will host a conference call and webcast today, August 11, 2022, at 8:30 a.m. ET, to discuss its financial results and business upd

Disposition of MPS programs to reduce operating expenses and extend projected cash runway into 2Q 2023 Focus R&D resources on EB-101 pivotal phase 3 VIITAL™ topline data expected in 3Q 2022 NEW YORK and CLEVELAND, May 13, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in cell and gene therapy, today announced financial results for the first quarter of 2022. The Company will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update. "During the quarter, we took significant steps to preserve our capital with the goal to fund operations over the next 12 months with existing

Phase 3 VIITAL™ study on track to complete enrollment in first quarter 2022 with final patients identified and under screening Added gene therapy and biopharmaceutical industry veterans to regulatory and quality teams to prepare for two Biologics License Application (BLA) submissions Formally settled dispute with REGENXBIO Inc., eliminating uncertainty from arbitration outcome and facilitating planning of resources to reach next value inflection points Conference call scheduled for Wednesday, November 17, 2021 at 8:30 a.m. ET NEW YORK and CLEVELAND, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today annou

Second clinical trial site activated in EB-101 pivotal Phase 3 VIITAL™ study Successful Type B meeting with U.S. FDA; Transpher A study will serve as the pivotal study for ABO-102 in MPS IIIA; Alignment with FDA on primary study endpoint Focusing resources on completing EB-101 and ABO-102 pivotal, registration-enabling studies Conference call scheduled for Thursday, July 29, 2021 at 8:30 a.m. ET NEW YORK and CLEVELAND, July 28, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced financial results for the second quarter 2021 and recent business progress. "The second quarter was a highly effective and produ