Abeona Therapeutics Announces Progress Update on Pz-cel Biologics License Application (BLA) [Yahoo! Finance]
Abeona Therapeutics Inc. (ABEO)
Last abeona therapeutics inc. earnings: 3/16 04:20 pm
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Source: Yahoo! Finance
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 (BIMO) inspection of Abeona and the BLA mid-cycle review meeting. The BIMO inspection was conducted from January 22, 2024 through January 24, 2024 at Abeona's headquarters in Cleveland, Ohio, and reviewed the conduct and practices that pertain to the clinical studies of pz-cel. The FDA inspector did not issue any observations or FDA Form 483s during the inspection. The formal report from the FDA regarding the BIMO inspection will be received at a later date. FDA's BIMO program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO program was established to assure the quality and integrity of data submitted to the agency in
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ABEO
News
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Abeona Therapeutics Inc. - ABEOPR Newswire
- Abeona Therapeutics Inc (NASDAQ: ABEO) had its price target lowered by analysts at Cantor Fitzgerald from $28.00 to $21.00. They now have an "overweight" rating on the stock.MarketBeat
- Abeona Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate ProgressGlobeNewswire
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Abeona Therapeutics Inc. - ABEOAccesswire
- SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Abeona Therapeutics Inc. - ABEOGlobeNewswire
ABEO
Earnings
- 5/15/24 - Miss
ABEO
Analyst Actions
- 5/16/24 - Cantor Fitzgerald
ABEO
Sec Filings
- 5/15/24 - Form S-8
- 5/15/24 - Form 10-Q
- 5/15/24 - Form 8-K
- ABEO's page on the SEC website