Atara Biotherapeutics Receives FDA Acceptance And Priority Review Of Biologics License Application For Tabelecleucel For Treatment Of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
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Atara Biotherapeutics has received FDA acceptance and priority review for its Biologics License Application for Tabelecleucel, a treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease. The Prescription Drug User Fee Act (PDUFA) target action date is January 15, 2025. If approved, Tabelecleucel would be the first approved therapy in the U.S. for this condition. The acceptance triggers a $20 million milestone payment from Pierre Fabre Laboratories, with an additional $60 million milestone if approved by the FDA.
July 17, 2024 | 1:05 pm
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Atara Biotherapeutics' Tabelecleucel has received FDA acceptance and priority review for its Biologics License Application. This acceptance triggers a $20 million milestone payment from Pierre Fabre Laboratories, with an additional $60 million milestone if approved by the FDA. The PDUFA target action date is January 15, 2025.
The FDA acceptance and priority review of Tabelecleucel is a significant milestone for Atara Biotherapeutics. The acceptance triggers a $20 million milestone payment, and if approved, an additional $60 million will be received. This news is likely to positively impact ATRA's stock price in the short term due to the financial milestones and the potential for the first approved therapy for EBV+ PTLD in the U.S.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100