TG Therapeutics Provides Update on FDA Meeting for GENUINE Phase 3 Trial
TG Therapeutics, Inc. (TGTX)
Last tg therapeutics, inc. earnings: 11/12 07:34 am
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US:NASDAQ Investor Relations:
ir.tgtherapeutics.com
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Source: GlobeNewswire
NEW YORK, Oct. 16, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics (NASDAQ:TGTX) announced today that it has met with the U.S. Food and Drug Administration (FDA) regarding the use of the results from the GENUINE Phase 3 trial to support a Biologics License Application (BLA) filing for approval of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib. During the meeting, the FDA confirmed that accelerated approval based on Overall Response Rate (ORR) would be a review issue. As part of the discussion, the FDA encouraged the Company to consider future available therapy in its risk/benefit analysis as part of any potential future BLA filing that may impact accelerated approval. The Company and the FDA also discussed the potential use of Progression Free Survival (PFS) results from the GENUINE trial to support the full approval of TG-1101. The Company plans to have a follow-up meeting with the FDA to discuss the use of the P
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News
- TG Therapeutics, Inc. (NASDAQ: TGTX) had its "buy" rating re-affirmed by analysts at LADENBURG THALM/SH SH. They now have a $39.00 price target on the stock.MarketBeat
- TG Therapeutics, Inc. (NASDAQ: TGTX) had its "overweight" rating re-affirmed by analysts at JPMorgan Chase & Co.. They now have a $25.00 price target on the stock.MarketBeat
- TG Therapeutics, Inc. (NASDAQ: TGTX) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $45.00 price target on the stock.MarketBeat
- TG Therapeutics Announces Additional Data Presentations for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual MeetingGlobeNewswire
- TG Therapeutics Awarded National Contract by the Department of Veterans Affairs for BRIUMVI as the Preferred Anti-CD20 for Relapsing Forms of Multiple Sclerosis [Yahoo! Finance]Yahoo! Finance
TGTX
Earnings
- 2/28/24 - Beat
TGTX
Sec Filings
- 4/18/24 - Form PRE
- 3/15/24 - Form 4
- 3/13/24 - Form 4
- TGTX's page on the SEC website