Abeona Therapeutics

Yahoo Finance • 6 days ago

Abeona Therapeutics® Reports Full Year 2024 Financial Results, Provides Pz-cel Regulatory Update and Commercial Launch Plans

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 CLE... Full story

Yahoo Finance • 2 months ago

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

CLEVELAND, Feb. 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 N... Full story

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 • 2 years ago

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 • 2 years ago

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 • 2 years ago

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 • 2 years ago

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 • 3 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