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TG Therapeutics down 20% premarket on potential extended timeline for U.S. marketing application for lead candidate TG-1101

Published 10/16/2017, 08:19 AM
© Reuters.  TG Therapeutics down 20% premarket on potential extended timeline for U.S. marketing application for lead candidate TG-1101
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  • TG Therapeutics (NASDAQ:TGTX) slumps 20% premarket on light volume in response to its announcement of the outcome of its recent meeting with the FDA to discuss the data supporting its planned marketing application seeking approval for lead candidate TG-1101, in combination with AbbVie's (NYSE:ABBV) IMBRUVICA (ibrutinib), in patients with high-risk chronic lymphocytic leukemia (CLL).
  • The company wants to use overall response rate (ORR), the primary endpoint in its successful Phase 3 GENUINE study, as the basis for accelerated approval. The FDA appears to be a bit equivocal saying it would be a "review issue" while recommending that the company consider future available therapy in its risk/benefit analysis to support its future Biologics License Application (BLA).
  • They also discussed the use of the progression-free survival (PFS) endpoint to support full approval for TG-1101. Apparently, more talks are necessary considering it will have a "follow-up meeting" with the agency to discuss the PFS endpoint in "more detail" before year-end. The company also says it "plans to monitor the regulatory landscape" for new approvals of agents for previously treated high-risk CLL.
  • TG plans to file its BLA in Q2 2018.
  • Previously: TG Therapeutics TG-1101/Imbruvica combo successful in late-stage CLL study; shares ahead 13% premarket (June 5)
  • Now read: Humira Biosimilar Threat: Who Gets The Customer First?

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