Celldex jumps after gaining an FDA 'breakthrough'

Shares of Celldex Therapeutics ($CLDX) shot up 20% this morning after the biotech announced that the FDA had provided its breakthrough therapy designation (BTD) for rindopepimut (Rintega), an experimental drug for patients with EGFRvIII-positive glioblastoma. The Hampton, NJ-based biotech says the BTD was provided based on midstage data for the brain cancer therapy. The Phase III program began late last year. The BTD is designed to give developers easy access to regulators in hopes of cutting down development time on cutting-edge treatments. "These patients have extremely limited treatment options, with only three new drugs approved in more than 20 years," says CEO Anthony Marucci. "Emerging clinical data suggests that rindopepimut may offer an improvement over existing standard of care for EGFRvIII-positive patients." Release

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