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News Breaks
December 9, 2012
12:35 EDTCLDXFinal Celldex data on CDX-011 supports overall survival benefit
Celldex Therapeutics, announced final results from the company’s randomized Phase 2b EMERGE study of CDX-011 in patients with glycoprotein NMB (GPNMB)-expressing, advanced, heavily pretreated breast cancer. The results presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium confirm preliminary findings reported in May and establish proof of principle with evidence of higher activity in patient subgroups with high GPNMB expression, including those with triple negative disease. Thomas Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics, commented, “The mature results presented today confirm the preliminary results shown previously and support advanced clinical development of CDX-011, which may play a critical role in treating patients with advanced breast cancer. We look forward to discussions with the Food and Drug Administration later this month to design a pivotal study intended to support approval of CDX-011 for specific patients with breast cancer.”
News For CLDX From The Last 14 Days
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February 25, 2015
18:51 EDTCLDXCelldex 7.25M share Secondary priced at $24.00
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February 24, 2015
16:00 EDTCLDXCelldex files to sell 7.25M shares of common stock
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07:15 EDTCLDXCelldex reports Q4 EPS (36c), consensus (35c)
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February 23, 2015
09:25 EDTCLDXOn The Fly: Pre-market Movers
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08:08 EDTCLDXCelldex rindopepimut receives FDA breakthrough therapy designation
Celldex Therapeutics announced that the FDA has granted rindopepimut Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma, or GBM. This application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies. An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment in December of 2014.

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