Advanced Accelerator Preps Lutetium-Tipped Warhead For NETs Filing

29 Sep 2015

• By John Davis

With positive Phase III clinical results in hand, France's Advanced Accelerator Applications SA (AAA) expects to start filing a rolling US NDA submission later this year and file a European marketing application in 2016 for its lead radiotherapeutic, Lutathera, to treat advanced mid-gut neuroendocrine tumors (NETs). The lutetium-labeled somatostatin analog met its primary endpoint in the Phase III NETTER-1 study.

The strength of the Phase III results could also bring to fruition AAA's plans to list on NASDAQ. The company already has a significant business in Europe selling PET and SPECT imaging agents, with sales last year of $92.9m generating a net loss of $11.4m

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