Alder BioPharmaceuticals announced it has submitted a biologics license application, or BLA, to the FDA for eptinezumab. Eptinezumab is an investigational monoclonal antibody, or mAb, for migraine prevention targeting the calcitonin gene-related peptide, or CGRP, and is Alder's lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a Q1 2020 commercial launch. Eptinezumab has been evaluated in several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in both chronic and episodic migraine prevention. The BLA includes, and is supported by, positive data from Alder's PROMISE 1 and PROMISE 2 Phase 3 clinical trials, open-label safety study, pharmacokinetic comparability study and chemistry, manufacturing, and controls, or CMC, data packages. Top-line results from the PROMISE 1 and PROMISE 2 Phase 3 clinical trials were presented at the American Association of Neurology and American Headache Society.