BUZZ-Atara jumps after US FDA backs re-submission of cancer drug application
Atara Biotherapeutics Inc ATRA | 0.00 |
** Shares of Atara Biotherapeutics ATRA.O rise 43% to $7.39
** 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
