BUZZ-Atara more than doubles after FDA backs re-submission of cancer drug application

Atara Biotherapeutics Inc

Atara Biotherapeutics Inc

ATRA

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Updates

** Shares of Atara Biotherapeutics ATRA.O rise 101% to over a three-month high of $10.35

** Stock set for its best percent gain on record, if gains hold

** Company meets with the U.S. Food and Drug Administration to discuss how to revive its application for cancer drug, tabelecleucel

** FDA agreed that a single-arm study with a historical comparison group can be enough to support a new application, Atara says

** Regulator declined to approve tabelecleucel in January, marking the second rejection after it had previously turned down the therapy over manufacturing inspection concerns

** Partner Pierre Fabre Pharmaceuticals plans to resubmit the application with updated patient data and longer follow-up from its late-stage trial

** Atara expects to share a further regulatory update in the third quarter

** Shares down 71% YTD