Abeona Therapeutics

Yahoo Finance • last year

Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)

- 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 th... Full story

Yahoo Finance • last year

Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments

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 dystroph... Full story

Yahoo Finance • last year

Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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 N... Full story

Yahoo Finance • last year

Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa

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-1... Full story

Yahoo Finance • last year

Abeona Therapeutics Appoints Madhav Vasanthavada, Ph.D., M.B.A. as Chief Commercial Officer

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 (B... Full story

Yahoo Finance • last year

Abeona Therapeutics Announces Positive Pre-BLA Meeting with FDA for EB-101 and Plans for BLA Submission

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... Full story

Yahoo Finance • last year

Abeona Therapeutics Announces Closing of $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

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 age... Full story

Yahoo Finance • last year

Abeona Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

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 prepar... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Announces Regulatory Update on Biologics License Application (BLA) for EB-101

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 ali... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Announces New Preclinical Data from its AAV Ophthalmology Program at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

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) ophthalmo... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update

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 Retinoschis... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Announces New Employee Inducement Grants

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 equit... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Reports Third Quarter 2022 Financial Results

Following positive topline data from Phase 3 VIITAL™study of EB-101 with both co-primary endpoints met, Abeona plans to submit BLA to U.S. FDA in 2Q 2023 Company well-funded with expected cash runway into 3Q 2024 NEW YORK and CLEVELAND,... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Announces $35 Million Private Placement Financing

NEW YORK and CLEVELAND, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) announced today that it has entered into a securities purchase agreement to sell 7,065,946 shares of its common stock, and, in lieu of shar... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Announces Database Lock for Pivotal Phase 3 VIITAL™ Study of EB-101 in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

NEW YORK and CLEVELAND, Oct. 19, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the database lock on October 18, 2022 for the pivotal Phase 3 VIITAL™ study of its investigational autologous, engineered c... Full story

Yahoo Finance • 2 years ago

Abeona Therapeutics Reports Second Quarter 2022 Financial Results

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... Full story

Yahoo Finance • 3 years ago

Abeona Therapeutics Granted Second 180-Day Period by Nasdaq to Regain Compliance with Minimum Bid Price Rule

NEW YORK and CLEVELAND, May 19, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that the Company has been granted an additional 180-day period from Nas... Full story

Yahoo Finance • 3 years ago

Ultragenyx Acquires Global Rights to AAV Gene Therapy ABO-102 for Sanfilippo Syndrome Type A (MPS IIIA) from Abeona Therapeutics

ABO-102 / UX111 is being evaluated in ongoing pivotal Transpher A trial in patients with MPS IIIA Interim data featured in encore oral presentation at American Society of Gene & Cell Therapy (ASGCT) today NOVATO, Calif. and NEW YORK and... Full story

Yahoo Finance • 3 years ago

Abeona Therapeutics Reports First Quarter 2022 Financial Results

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 NE... Full story

Yahoo Finance • 3 years ago

Abeona Therapeutics Announces AAV204, a Novel AAV Capsid, Demonstrated Robust Macular Transduction Following Para-Retinal Administration in Non-Human Primates

NEW YORK and CLEVELAND, Ohio, May 04, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced the presentation of new preclinical data on AAV204 at the Associa... Full story