AAA today announced its financial results for the third quarter of 2016 and that the U.S. Food and Drug Administration (FDA) issued feedback on its New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Third Quarter Highlights:
– Sales for the third quarter of 2016 increased 15.4% compared to the third quarter of 2015
– Closed $150 million follow-on public offering and subsequent underwriters option to purchase additional $22.5 million
– The U.S. Food and Drug Administration (FDA) issued feedback via a Discipline Review Letter on the New Drug Application (NDA) for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
– The European Medicines Agency (EMA) issued a positive opinion on the Marketing Authorization Application for SomaKit TOC
– Achieved marketing authorization in Switzerland for DOPAVIEW and AAACholine
– Initiated two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin) in cardiovascular and cardio-oncology indications