Celldex reiterated as a Focus Pick at Roth Capital Roth Capital reiterated Celldex as its Focus Pick citing its broad pipeline and the potential for accelerated approval for either ORR or PFS. Shares are Buy rated with a $16 price target.
Celldex 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.