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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News
- Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offering of Common Stock and Pre-Funded Warrants [Yahoo! Finance]Yahoo! Finance
- Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offering of Common Stock and Pre-Funded WarrantsGlobeNewswire
- Buying The Dip In Abeona Therapeutics After The Recent Manufacturing-Related CRL [Seeking Alpha]Seeking Alpha
- Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of InvestorsBusiness Wire
- INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of InvestorsBusiness Wire
ABEO
Sec Filings
- 5/3/24 - Form 8-K
- 5/3/24 - Form 424B5
- 5/3/24 - Form 8-K
- ABEO's page on the SEC website