Advanced Accelerator Applications reports 26.8% sales growth in 2015 and continues to show significant clinical progress across both therapeutic and diagnostic platforms – Company announces completed submission of Lutathera NDA and MAA to FDA and EMA respectively


Advanced Accelerator Applications today announced its Q4 and full year 2015 financial results. The company reported an increase in year-on-year sales of 26.8% for the full-year and a 14% increase for Q4 2015 compared to Q4 2014. For the year ended 31 December 2015 total sales were €88.6 million (+26.8% vs. 2014).

Other key news announced is that the company had completed its rolling NDA submission to the FDA and that it had also recently submitted a Lutathera MAA to the EMA. In these filings AAA has asked for priority review to the FDA and Accelerated Assessment to the EMA.

Mr. Stefano Buono, AAA’s CEO, commented, “2015 was a pivotal year for AAA. We continued our trend of significant sales growth, and the year was marked by the completion of two key milestones, namely: the completion of our IPO and simultaneous listing on the Nasdaq under the ticker “AAAP” and the announcement of favourable results from the pivotal Phase 3 NETTER-1 trial evaluating our lead therapeutic candidate, Lutathera. We also submitted an NDA and MAA in the U.S. and Europe, respectively, for Somakit, which could be the ideal in-vivo companion diagnostic for Lutathera.”

Mr. Buono concluded, “In 2016, we have already achieved several key milestones to advance the company forward and support our future success. With our Lutathera filing now complete and submitted to the FDA and the EMA and the anticipated Somakit approval in both the US and Europe, we look forward to reporting our commercial developments gearing up towards the launch of both products.”