Abeona Therapeutics Announces FDA Accepts and Grants Priority Review for Pz-cel Biologics License Application (BLA)
November 27, 2023 07:30 ET
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Abeona Therapeutics Inc.
- 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....
Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments
November 13, 2023 07:30 ET
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Abeona Therapeutics Inc.
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...
Abeona Therapeutics Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
November 01, 2023 07:30 ET
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Abeona Therapeutics Inc.
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...
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
September 26, 2023 07:30 ET
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Abeona Therapeutics Inc.
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...
Abeona Therapeutics Appoints Madhav Vasanthavada, Ph.D., M.B.A. as Chief Commercial Officer
September 12, 2023 07:30 ET
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Abeona Therapeutics Inc.
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...
Abeona Therapeutics Announces Participation in Upcoming Investor Conferences
September 07, 2023 07:30 ET
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Abeona Therapeutics Inc.
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...
Abeona Therapeutics Announces Positive Pre-BLA Meeting with FDA for EB-101 and Plans for BLA Submission
August 30, 2023 07:30 ET
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Abeona Therapeutics Inc.
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)...
Abeona Therapeutics Reports Second Quarter 2023 Financial Results
August 08, 2023 07:30 ET
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Abeona Therapeutics Inc.
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...
Abeona Therapeutics Announces Submission of Briefing Package for Pre-Biologics License Application (BLA) Meeting with FDA in August 2023
July 28, 2023 07:30 ET
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Abeona Therapeutics Inc.
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...
Abeona Therapeutics Joins Rare Disease Company Coalition
July 19, 2023 08:30 ET
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Abeona Therapeutics Inc.
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...