Health and Healthcare
Atara Biotherapeutics Wins FDA Clearance for Late-Stage Trials
Published:
Last Updated:
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).
Also, 24/7 Wall St. has taken a look at 10 other major biotech events coming in the first month of 2018. These events could influence a move of over 10% in the stock, whether it’s to the upside or downside.
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.
Want to Retire Early? Start Here (Sponsor)
Want retirement to come a few years earlier than you’d planned? Or are you ready to retire now, but want an extra set of eyes on your finances?
Now you can speak with up to 3 financial experts in your area for FREE. By simply clicking here you can begin to match with financial professionals who can help you build your plan to retire early. And the best part? The first conversation with them is free.
Click here to match with up to 3 financial pros who would be excited to help you make financial decisions.
Have questions about retirement or personal finance? Email us at [email protected]!
By emailing your questions to 24/7 Wall St., you agree to have them published anonymously on a673b.bigscoots-temp.com.
By submitting your story, you understand and agree that we may use your story, or versions of it, in all media and platforms, including via third parties.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
