- 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

CLEVELAND, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced the appointment of Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD as new independent members to its Board of Directors. Dr. Zeiher brings more than 20 years of drug development experience where, in various roles, he oversaw the approval of 15 new treatments that addressed unmet needs in serious diseases with few to no treatment options. Dr. Crombez currently serves as Chief Medical Officer of Ultragenyx Pharmaceutical Inc. and brings extensive expertise in the development and execution of clinical development programs for rare genetic disorders. Michael Amoroso, Chairman of Abeon

CLEVELAND, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced the appointment of Madhav Vasanthavada, Ph.D., M.B.A. to the role of Chief Commercial Officer (CCO) and Head of Business Development (BD), effective immediately. In this capacity, in addition to his current BD responsibilities, Dr. Vasanthavada will oversee all aspects of commercial strategy, planning and operations as Abeona prepares for a potential launch of EB-101, its investigational, genetically engineered autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). Dr. Vasanthavada is a seasoned commercial executive bringing over 20 years of experience with leadershi

NEW YORK and CLEVELAND, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Jon Voss as Vice President, Head of Quality. Mr. Voss, who has been advising the Company as a consultant, will now serve in a leadership role to further strengthen Abeona's quality system and oversee all quality functions. "Jon is a proven technical leader with a strong track record of successful quality oversight that includes chemistry, manufacturing and control (CMC)-related and clinical functions for gene therapies," said Dr. Vish Seshadri, Ph.D., M.B.A., Head of Research & Clinical Development and CEO-

Steven H. Rouhandeh to retire as Chairman of the Board; Michael Amoroso appointed Chairman of the Board Vishwas Seshadri, Ph.D., M.B.A. to become Chief Executive Officer Brendan M. O'Malley, J.D., Ph.D. promoted to General Counsel, Brian Kevany, Ph.D. promoted to Chief Technical Officer, Scott Nogi, M.B.A., Head of Business Operations to expand role and lead operations at Abeona's Cleveland facility Regulatory veterans in AAV-based gene therapy, Carl Denny and Kate Imhoff, added to team in preparation for two upcoming Biologics License Application submissions NEW YORK and CLEVELAND, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integ

NEW YORK and CLEVELAND, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Edward Carr as Chief Financial Officer and Principal Financial Officer, effective immediately. Mr. Carr had served as Abeona's Chief Accounting Officer since January 2019. "I look forward to working together with Ed to meet our near-term clinical and regulatory milestones, as well as set Abeona on a course for longer-term success for patients and shareholders," said Michael Amoroso, Chief Executive Officer of Abeona. "Ed's financial leadership and deep understanding of our business helps position Abeona for

NEW YORK and CLEVELAND, May 25, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Vishwas Seshadri, Ph.D., M.B.A., as Senior Vice President, Head of Research & Clinical Development, effective June 1, 2021. Dr. Seshadri joins the company from Celgene Corporation, now a subsidiary of Bristol-Myers Squibb Company (BMS), and brings more than 20 years of experience including in academia and various senior and executive leadership roles in the life sciences industry overseeing product development, regulatory submissions, and commercialization for novel therapies including personalized, autologou

Patient enrollment ongoing for EB-101 pivotal Phase 3 VIITAL™ study Positive interim MPS III data presented at 17th Annual WORLDSymposium; additional neurocognitive assessments of patients treated in high dose cohort 3 in MPS IIIA Transpher A study and additional clinical data from MPS IIIB Transpher B study expected in 2021 Strengthened management and board to support the company's focus on driving future growth, enhancing corporate governance, and creating additional shareholder value Conference call scheduled for Tuesday, May 25, 2021 at 8:30 a.m. ET NEW YORK and CLEVELAND, May 18, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and

NEW YORK and CLEVELAND, April 19, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Dr. Leila Alland and Mr. Donald Wuchterl as new independent members to its Board of Directors. "Leila and Donald bring a collective wealth of diverse biologics experience to Abeona that spans clinical development and manufacturing of cell therapy and gene therapy products, as we continue to focus on the mission of bringing our novel gene and cell therapies to patients who currently have no approved treatment options," said Steven H. Rouhandeh, Chairman of Abeona's Board of Directors. "Their relevant ex

NEW YORK and CLEVELAND, March 25, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of two new independent members to its Board of Directors with significant biotechnology and life sciences experience: Faith L. Charles, Partner, Corporate Transactions and Securities at Thompson Hine LLP and Mark Alvino, President at life sciences strategic advisory firm Hudson Square Capital LLC. “In addition to the experience and backgrounds of the current Abeona directors, our two new board members represent a group of highly qualified and diverse executives who bring fresh perspectives, relevant exper

NEW YORK and CLEVELAND, March 22, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that Michael Amoroso, Executive Vice President, Chief Operating Officer (COO) and principal executive officer at Abeona, has been promoted to President, Chief Executive Officer (CEO) and a member of the company’s Board of Directors, effective immediately. “Michael’s promotion to CEO reflects his unwavering commitment and outstanding operational leadership during a period of important transition for the company, and the Board fully supports him and the Abeona senior management team,” said Steven H. Rouhandeh, Chairman of Ab

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- 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, the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), now commercially available in the U.S. - - Ann & Robert H. Lurie Children's Hospital of Chicago, a top-ranked hospital, is ready to evaluate patients for ZEVASKYN treatment - - Abeona Assist™ comprehensive patient services program in place to offer personalized support for eligible patients and their families throughout ZEVASKYN treatment journey - CLEVELAND and CHICAGO, May 14, 2025 (GLOBE NEWSWIRE) -- Correction for Trademark symbol in headline - Abeona Therapeutics Inc. (NASDAQ:ABEO) and Ann & Robert H. Lurie Children's Hospital of Chicago today announced that L

- ZEVASKYN, the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), now commercially available in the U.S. - - Ann & Robert H. Lurie Children's Hospital of Chicago, a top-ranked hospital, is ready to evaluate patients for ZEVASKYN treatment - - Abeona Assist™ comprehensive patient services program in place to offer personalized support for eligible patients and their families throughout ZEVASKYN treatment journey - CLEVELAND and CHICAGO, May 14, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) and Ann & Robert H. Lurie Children's Hospital of Chicago today announced that Lurie Children's is now activated as the

CLEVELAND, May 12, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million upon the closing of the transaction. Abeona was awarded the PRV following the U.S. Food and Drug Administration (FDA) approval of ZEVASKYN™ (prademagene zamikeracel) on April 28, 2025. "With proceeds from this PRV sale, we have sufficient cash for more than two years of operating expenses without the need for capital infusion and not accounting for ZEVASKYN sales," said Joe Vazzano, Chief Financial Officer of Abeona. "Furthermore, with

CLEVELAND, May 07, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On April 30, 2025, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to seven individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 21,500 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the

- 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

CLEVELAND, April 01, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On March 31, 2025, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to six individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 23,700 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the

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

CLEVELAND, March 04, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced that Abeona's Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., will present at the Leerink Partners Global Healthcare Conference in Miami, Florida on Monday, March 10, 2025 at 3:00 p.m. Eastern Time. A live webcast of the presentation can be accessed on the Investors section of the Abeona website under "Events" at https://investors.abeonatherapeutics.com/events. The webcast will be archived for 30 days. About Abeona Therapeutics Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Prademagene zamikeracel (pz-

CLEVELAND, March 03, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4). On February 28, 2025, the Compensation Committee of Abeona's Board of Directors granted restricted stock equity awards as a material inducement to employment to five individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 16,300 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that