Biohaven Pharmaceutical Holding Company Ltd.'s experimental migraine drug rimegepant has been accepted for review by the U.S. Food and Drug Administration.
Rimegepant, which would be an oral tablet, will receive a decision from the FDA in the first fiscal quarter of 2020, New Haven, Conn.-based Biohaven announced in a Sept. 4 release.
Biohaven's stock was trading up approximately 8.1% to $41.17 as of 9:39 a.m. ET.
According to Biohaven, the FDA does not plan to hold an advisory committee meeting for rimegepant, and the agency's preliminary evaluation of the drug has found no potential review issues. The FDA is likely "satisfied" with rimegepant's safety and efficacy data, Leerink analyst Marc Goodman wrote in a Sept. 4 note.
Rimegepant is a calcitonin gene-related peptide, or CGRP, drug that blocks a protein found in high levels in the head and neck's sensory nerves during migraine attacks. Other CGRP migraine drugs, including Eli Lilly and Co.'s and Teva Pharmaceutical Industries Ltd.'s, have already been FDA-approved.
