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Biotech Stocks Facing FDA Decision in January 2018

 Advanced Accelerator Applications
Advanced Accelerator Applications

The FDA decision on Advanced Accelerator Applications S.A.’s (AAAP) resubmitted New Drug Application for experimental drug Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors is expected to be announced on January 26, 2018.

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), also known as carcinoids and islet cell tumors, are tumors derived from neuroendocrine cells that can occur anywhere along the gastrointestinal tract.

Lutathera is a Lu-177-labeled somatostatin analogue peptide, and it belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (“PRRT“).

Lutathera was turned down by the FDA last December, and the Company was asked to file new subgroup data, provide a safety update, and make revisions to the previously submitted data.

This is the Company’s second attempt to get Lutathera approved in the U.S.

The European Commission approved Lutathera for gastroenteropancreatic neuroendocrine tumors in late September of this year.

Baader Helvea analyst Bruno Bulic has pegged peak sales potential of Lutathera at $2 billion.

Novartis has agreed to acquire Advanced Accelerator Applications for $3.9 billion, and a tender offer related to the same commenced earlier this month. The Offer will expire at 12:00 midnight, New York City time, on January 19, 2018, unless extended.

AAAP closed Tuesday’s (Dec.26) trading at $81.59, down 0.01%.