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News Breaks
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.
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August 12, 2014
08:34 EDTGERNGeron says imetelstat remains on full clinical hold
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August 11, 2014
18:29 EDTGERNOn The Fly: After Hours Movers
UP AFTER EARNINGS: DealerTrack (TRAK), up 11.3%... DTS Inc. (DSTI), up 12.8%... Globalstar (GSAT), up 1.6%... Halozyme Therapeutics (HALO), up 2.4%. ALSO HIGHER: Intercept Pharmaceuticals (ICPT), up 57.7% after announcing that 46% of OCA group met FLINT endpoint as well as reporting second quarter results... Cempra (CEMP), up 5.8% following Intercept Pharmaceuticals' FLINT announcement... Scotts Miracle-Gro (SMG), up 3.6% after board approves a $500M share repurchase authorization and announces a $2.00 per share special dividend. DOWN AFTER EARNINGS: Galena Biopharma (GALE), down 13.4%... Nuance Communications (NUAN), down 9.7%... Millennial Media (MM), down 7.1%... MasTec (MTZ), down 3.6%... Turtle Beach (HEAR), down 3.5%... magicJack (CALL), down 5.8%... Geron (GERN), down 2.4%. ALSO LOWER: Sprouts Farmers Market (SFM), down 3.7% after filing to sell 15M shares of common stock for holders.
16:31 EDTGERNGeron reports Q2 EPS (6c), consensus (6c)
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