ABEO: Type A Meeting with FDA Concluded; BLA Submission on Track for 2H24… [Yahoo! Finance]
Abeona Therapeutics Inc. (ABEO)
Last abeona therapeutics inc. earnings: 3/16 04:20 pm
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Source: Yahoo! Finance
Abeona Therapeutics, Inc. (NASDAQ:ABEO) is currently working on the resubmission of the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Recently, Abeona completed a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the resubmission. During the meeting, Abeona shared data and reports addressing nearly all the deficiencies noted in the Complete Response Letter (CRL). The company and the FDA came to preliminary alignment on those issues pending formal review of the data. There are two remaining outstanding items related to sterility assays and identity assays, with validation currently ongoing under protocols that incorporate FDA feedback. The company remains on track to resubmit the BLA for pz-cel before the end of the year. Following acceptance of the BLA, we anticipate a PDUFA date 6 months from the date of resubmission. In regards to commercial preparation, the
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ABEO
News
- Abeona Therapeutics Inc (NASDAQ: ABEO) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $18.00 price target on the stock.MarketBeat
- Abeona Therapeutics Inc (NASDAQ: ABEO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Abeona Therapeutics® Announces Participation in Upcoming Investor ConferencesGlobeNewswire
- Abeona Therapeutics Inc (NASDAQ: ABEO) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
- Abeona Therapeutics® Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
ABEO
Earnings
- 8/12/24 - Beat
ABEO
Sec Filings
- 9/24/24 - Form 4
- 8/27/24 - Form 4
- 8/27/24 - Form 4
- ABEO's page on the SEC website