Abeona Therapeutics Provides Regulatory Update Ahead of Pivotal Phase 3 Clinical Trial for EB-101 in Recessive Dystrophic Epidermolysis Bullosa
Abeona Therapeutics Inc. (ABEO)
Last abeona therapeutics inc. earnings: 3/16 04:20 pm
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Source: GlobeNewswire
Company to provide additional transport stability data points in response to FDA Clinical Hold LetterCMC clearance for VIITAL™ trial anticipated in Q4 2019Investor conference call today, Monday, September 23 at 09:30 a.m. ET NEW YORK and CLEVELAND, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that it has recently received a clinical hold letter from the U.S. Food and Drug Administration (FDA) clarifying that the FDA will not provide approval for the Company to begin its planned Phase 3 clinical trial for EB-101 until it submits to the FDA additional data points on transport stability of EB-101 to clinical sites. Over the last 12 months, the Company has worked closely with the FDA to address and narrow open Chemical, Manufacturing and Controls (CMC) items and has been working to resolve this one item identified in the FDA Clinical Hold Letter. The Company continues to anticipate receiv
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ABEO
News
- RARE Submits BLA to the FDA for Sanfilippo Syndrome Gene Therapy [Yahoo! Finance]Yahoo! Finance
- 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
- Abeona Therapeutics Inc (NASDAQ: ABEO) was upgraded by analysts at StockNews.com from a "sell" rating to a "hold" rating.MarketBeat
- Abeona Therapeutics Inc (NASDAQ: ABEO) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $15.00 price target on the stock.MarketBeat
ABEO
Earnings
- 11/14/24 - Miss
ABEO
Sec Filings
- 12/20/24 - Form 8-K
- 11/14/24 - Form SC
- 11/14/24 - Form SCHEDULE
- ABEO's page on the SEC website