3 April 2018 - Motif Bio today announced the initiation of a rolling submission of a new drug application to the U.S. FDA for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections. 

The submission is expected to be completed during the second quarter of 2018.

Upon acceptance for filing by the submission of a complete NDA, iclaprim will receive priority review status which will result in a review period of up to six months. Upon approval as a new chemical entity with QIDP designation, iclaprim will be eligible for 10 years of market exclusivity in the U.S. starting from the date of first approval.

Read Motif Bio press release