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... Read More

CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for recessive dystrophic epidermolysis bullosa (RDEB). The FDA has... Read More

CLEVELAND, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its management team will participate in upcoming investor conferences in November 2024: Truist Securities BioPharma Symposium: Investor meetings on Thursday, November 7, 2024. Stifel 2024 Healthcare Conference: Fireside chat on Monday, November 18, 2024 at 4:10 p.m. ET and investor meetings. A live webcast of... Read More

CLEVELAND, Nov. 01, 2024 (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 October 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to... Read More

CLEVELAND, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc . (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or Agency) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB). “We... Read More

CLEVELAND, Oct. 01, 2024 (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 September 30, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment... Read More

CLEVELAND, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its management team will participate in upcoming investor conferences in September 2024: Wells Fargo Healthcare Conference: Investor meetings on Thursday, September 5, 2024. H.C. Wainwright Annual Global Investment Conference: Company presentation on Tuesday, September 10, 2024 at 1:30 p.m. ET and investor... Read More

CLEVELAND, Sept. 02, 2024 (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 August 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to... Read More

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... Read More

CLEVELAND, Ohio, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Centers for Medicare and Medicaid Services (CMS) has granted a product-specific procedure code ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) for prademagene zamikeracel (pz-cel), Abeona’s investigational autologous cell-based gene therapy currently in development... Read More

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... Read More

CLEVELAND, Aug. 01, 2024 (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 July 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to two... Read More

CLEVELAND and LONDON, July 11, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a cell and gene therapy company with proprietary adeno-associated virus (AAV)-based capsids, and Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, today announced an agreement by which Beacon will evaluate Abeona's patented AAV204 capsid for the development and commercialization of potential... Read More

CLEVELAND, July 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Abeona’s Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will participate in a virtual fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 9:45 a.m. Eastern Time. A live webcast of the fireside chat will be available... Read More

CLEVELAND, June 03, 2024 (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 May 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to... Read More

CLEVELAND, May 28, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its senior management team will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 11:30 a.m. Eastern Time. The Company will also participate in one-on-one investor meetings at the conference. A live webcast of the fireside chat will be available on the... Read More

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... Read More

CLEVELAND, May 07, 2024 (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 May 6, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to ten... Read More

CLEVELAND, May 03, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) (“Abeona” or the “Company”) today announced the pricing of an underwritten offering of 12,285,056 shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656 shares of its common stock, at an offering price of $4.07 per share, which is equal to the closing price on Thursday, May 2, 2024, or $4.0699 per... Read More

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... Read More

CLEVELAND, April 01, 2024 (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, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to... Read More

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... Read More

CLEVELAND, March 05, 2024 (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 29, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment... Read More

CLEVELAND, Feb. 01, 2024 (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 January 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to... Read More

On track for PDUFA target action date of May 25, 2024 CLEVELAND, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced, as part of the review process by the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB), completion by the FDA of both a Bioresearch Monitoring... Read More

CLEVELAND, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has entered into a $50 million credit facility with the Avenue Venture Opportunities Fund, L.P. The credit agreement, which has a term of three and a half years, includes a first tranche of $20 million at closing, a second tranche of $10 million of committed capital, and an additional accordion option to upsize the... Read More

CLEVELAND, Dec. 15, 2023 (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 December 14, 2023, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to... Read More

PDUFA target action date is May 25, 2024 FDA does not currently plan to hold Advisory Committee meeting for pz-cel BLA CLEVELAND, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel), Abeona’s investigational autologous,... Read More

Abeona’s first-ever U.S. Biologics License Application (BLA) submission completed in September 2023 FDA decision on priority review and acceptance of BLA for pz-cel (prademagene zamikeracel, formerly known as EB-101) in recessive dystrophic epidermolysis bullosa (RDEB) expected by late-November 2023 Initiated commercial readiness activities for potential U.S. launch of pz-cel CLEVELAND, Nov. 13, 2023 (GLOBE NEWSWIRE) --... Read More

CLEVELAND, Nov. 01, 2023 (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 October 31, 2023, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to... Read More

CLEVELAND, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of EB-101, its investigational autologous, engineered cell therapy, as a treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB). As part of the submission, Abeona requested a... Read More

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... Read More

CLEVELAND, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that members of its management team will participate in upcoming investor conferences in September 2023: A company presentation at the H.C. Wainwright Annual Global Investment Conference on Wednesday, September 13, 2023 at 10:00 a.m. ET. A fireside chat at the Cantor Global Healthcare Conference on Tuesday, September 26,... Read More

CLEVELAND, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the Company’s intention to proceed with the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EB-101, its investigational autologous, engineered cell therapy, for patients with recessive dystrophic epidermolysis bullosa (RDEB) after the recent completion of a pre-BLA... Read More

On track for Biologics License Application (BLA) submission in third quarter of 2023 Proceeds from $25 million registered direct offering in July allow initiation of pre-commercial launch activities for EB-101 Cash on hand plus proceeds from registered direct offering projected to fund operations into the fourth quarter of 2024 CLEVELAND, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today... Read More

CLEVELAND, July 28, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has completed the submission of the briefing package to the U.S. Food and Drug Administration (FDA) for the Company’s pre-Biologics License Application (BLA) meeting in August 2023. The purpose of the pre-BLA meeting is to discuss with the FDA the format, content, and acceptability of the anticipated BLA for EB-101,... Read More

CLEVELAND, July 19, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has joined the Rare Disease Company Coalition (RDCC), an alliance of life science companies committed to discovering, developing, and delivering therapies for patients impacted by rare diseases. Abeona’s Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., has been appointed to the RDCC’s Board of Directors. Mr.... Read More

CLEVELAND, July 07, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the closing of its previously announced registered direct offering for total gross proceeds of $25 million, before deducting the placement agents’ fees and other offering expenses. “Our existing institutional investors have shown their confidence in Abeona by participating in this registered direct offering without discounts or... Read More

CLEVELAND, July 03, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has raised $25 million at-the-market from select existing investors, primarily to fund initiation of the Company’s launch preparations in anticipation of the EB-101 Biologics License Application (BLA) submission and potential approval. The company has entered into definitive agreements with certain existing... Read More

CLEVELAND, June 09, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received feedback from the U.S. Food and Drug Administration (FDA) on June 8, 2023, in which the Company gained the Agency’s alignment on the data required to establish retroviral vector (RVV) comparability, a critical Chemistry, Manufacturing and Controls (CMC) component for the EB-101 Biologics License Application... Read More

CLEVELAND, June 01, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Vish Seshadri, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Friday, June 9, 2023 at 9:00 a.m. Eastern time. The Company will also participate in one-on-one investor meetings at the conference. A live webcast of the fireside chat will be available on the Investors... Read More

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)... Read More

CLEVELAND, May 16, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced new data regarding three internally developed preclinical gene therapy product candidates from its adeno-associated virus (AAV) ophthalmology program that will be presented at the 26 th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), taking place from May 16-20, 2023 in Los Angeles, CA. “The preclinical... Read More

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... Read More

CLEVELAND, May 11, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced an oral presentation of additional data from the Company's pivotal Phase 3 VIITAL™ study evaluating its investigational EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The data presentation occurred earlier today during the inaugural International Societies for Investigative Dermatology (ISID) Meeting in Tokyo,... Read More

CLEVELAND, April 10, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the acceptance of three abstracts at the 26 th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place from May 16-20, 2023 in Los Angeles, CA. Accepted abstracts include new data on three internally developed investigational preclinical gene therapy product candidates from its adeno-associated... Read More

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... Read More

NEW YORK and CLEVELAND, March 24, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new employees who joined Abeona. On March 23, 2023, Abeona granted restricted stock equity awards to six employees as an inducement for them to accept employment, which equity awards relate to, in the aggregate, up to 131,750 restricted shares of Abeona common stock. One-quarter... Read More

NEW YORK and CLEVELAND, March 16, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that additional data from its pivotal Phase 3 VIITAL™ study of EB-101 for recessive dystrophic epidermolysis bullosa (RDEB) has been accepted for an oral presentation at the inaugural International Societies for Investigative Dermatology (ISID) Meeting, being held May 10-13, 2023 in Tokyo, Japan. Abeona... Read More

Advancing AAV-based gene therapy candidates toward IND studies on encouraging animal proof of concept data in Stargardt Disease, X-linked Retinoschisis (XLRS), and Autosomal Dominant Optic Atrophy (ADOA) To submit first pre-Investigational New Drug (IND) application meeting request this month NEW YORK and CLEVELAND, March 14, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced three internally... Read More