Loxo completes US filing for Bayer-partnered TRK inhibitor

26 March 2018

With the rolling submission of the New Drug Application (NDA) now complete, there will be more than a few fingers crossed at both US biotech Loxo Oncology (Nasdaq:LOXO) and German pharma major Bayer (BAYN: DE).

It is now down to the US Food and Drug Administration (FDA) to decide whether to approve Loxo’s NDA for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

Loxo could earn as much as $1.55 billion from Bayer as part of an exclusive global collaboration for the development and commercialization of larotrectinib and the follow-up compound, LOXO-195.

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