Health and Healthcare
Atara Biotherapeutics Wins FDA Clearance for Late-Stage Trials
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Atara Biotherapeutics Inc. (NASDAQ: ATRA) shares surged on Friday after the firm announced that it received clearance from the U.S. Food and Drug Administration (FDA) to initiate two Phase 3 clinical studies. Specifically these mid-stage studies deal with tabelecleucel in patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD).
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Atara intends to initiate these studies imminently. Tabelecleucel is Atara’s off-the-shelf T-cell immunotherapy in development for the treatment of EBV+PTLD, as well as other EBV associated hematologic and solid tumors.
The Phase 3 studies are expected to open for enrollment in the United States imminently and will later expand to include sites in the European Union, Canada and Australia.
Looking ahead, results from the first tabelecleucel Phase 3 study to reach the primary endpoint are expected to be announced in the first half of 2019. Atara also plans to submit a tabelecleucel Conditional Marketing Authorization (CMA) application in the EU for patients with rituximab-refractory EBV+PTLD following HCT during the first half of 2019.
Isaac Ciechanover M.D., CEO and president of Atara, commented:
We are delighted to have received FDA clearance to start the tabelecleucel Phase 3 clinical studies. This achievement included extensive collaboration with the FDA under Breakthrough Therapy Designation and we expect tabelecleucel to be the first off-the-shelf T-cell immunotherapy to begin Phase 3 clinical development in the U.S. Receiving clearance to initiate these studies is a significant milestone for Atara, and we expect to open our initial clinical sites imminently to serve the substantial unmet need for patients with this life-threatening condition.
Shares of Atara were last seen up about 25% at $19.10, with a consensus analyst price target of $28.00 and a 52-week range of $11.80 to $23.00.
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