Loxo eyeing larotrectinib registration

Loxo Oncology Inc. (NASDAQ:LOXO) gained $6.95 (26%) to $33.86 after it disclosed a submission timeline for larotrectinib (LOXO-101) and reported new data from a Phase I study of the candidate. The company expects to submit an NDA to FDA by early 2018, with an EMA submission to follow in 2018.

In a pipeline update Monday, Loxo said it has reached 85% enrollment in its Phase II NAVIGATE trial of larotrectinib, a basket trial enrolling patients with tropomyosin receptor kinase (TRK) fusion cancers across tumor types. In 2H17, the company expects to release top-line NAVIGATE results which it said will form the basis of its NDA. The company also said FDA awarded the candidate rare pediatric disease designation to treat infantile fibrosarcoma. ...