Picture of Atara Biotherapeutics logo

ATRA Atara Biotherapeutics News Story

0.000.00%
us flag iconLast trade - 00:00
HealthcareSpeculativeSmall CapMomentum Trap

Atara jumps after US FDA backs re-submission of cancer drug application

** 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

 (Reporting by Kamal Choudhury in Bengaluru)

 ((Kamal.Choudhury@thomsonreuters.com;))

Recent news on Atara Biotherapeutics

See all news