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March 12, 2014
05:47 EDTGERNGeron announces IND clinical hold affecting trials of imetelstat
Geron announced that the company has received verbal notice from the FDA that its Investigational New Drug, or IND, application for imetelstat has been placed on full clinical hold, affecting all ongoing company-sponsored clinical trials. A full clinical hold is an order that the FDA issues to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial. The clinical hold affects the remaining eight patients in the company's Phase 2 study in essential thrombocythemia or polycythemia vera and the remaining two patients in the company's Phase 2 study in multiple myeloma. In addition, the company's planned Phase 2 clinical trial in myelofibrosis will likely be delayed due to the clinical hold. It is possible that other studies using imetelstat, such as ongoing investigator-sponsored trials, may also be placed on clinical hold by the FDA. Geron has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday afternoon, the FDA indicated that the clinical hold is due to the occurrence of persistent low-grade liver function test, or LFT, abnormalities observed in the Phase 2 study of imetelstat in ET/PV patients and the potential risk of chronic liver injury following long- term exposure to imetelstat. The FDA expressed concern about whether these LFT abnormalities are reversible. Geron plans to work diligently with the FDA to seek the release of the clinical hold.
News For GERN From The Last 14 Days
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September 3, 2015
09:22 EDTGERNOn The Fly: Pre-market Movers
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September 2, 2015
18:39 EDTGERNOn The Fly: After Hours Movers
UP AFTER EARNINGS: SeaChange (SEAC), up 4.5%... Planet Fitness (PLNT), up 7.1%. ALSO HIGHER: Geron (GERN), up 19.7% after publishing two papers in The New England Journal of Medicine... Lannett (LCI), up 16.6% after announcing that it will acquire Kremers Urban. DOWN AFTER EARNINGS: Five Below (FIVE), down 9.3%... Verint Systems (VRNT), down 6.1%... Catalent (CTLT), down 4.9%.
17:04 EDTGERNGeron announces publication of two papers in NEJM
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August 28, 2015
17:23 EDTGERNGeron files $250M mixed securities shelf

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