Abeona Therapeutics Reports Full Year 2023 Financial Results and Announces Completion of FDA Inspections
Abeona Therapeutics Inc. (ABEO)
Last abeona therapeutics inc. earnings: 3/16 04:20 pm
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investors.abeonatherapeutics.com
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Source: GlobeNewswire
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 pz-cel, as well as performance of in-process and release assays. The two-week PLI, which was conducted by five FDA inspectors, concluded on March 1, 2024. Upon completion of the inspection, a Form 483 was issued with observations related to process controls. On March 15, 2024, the Company submitte
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ABEO
News
- SHAREHOLDER ALERT: Abeona Therapeutics Investigated by Block & Leviton For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the FirmAccesswire
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Abeona Therapeutics Inc. - ABEOGlobeNewswire
- Abeona Therapeutics Tanks On CRL From The FDA, But All Hope Is Not Lost [Seeking Alpha]Seeking Alpha
- SHAREHOLDER ALERT: Abeona Therapeutics Investigated by Block & Leviton For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the FirmAccesswire
- Abeona Therapeutics Inc (NASDAQ: ABEO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
ABEO
Sec Filings
- 4/26/24 - Form 4
- 4/26/24 - Form 4
- 4/24/24 - Form 8-K
- ABEO's page on the SEC website