FDA nod for Biohaven's Nurtec ODT

Biohaven Pharmaceutical Holding (NYSE: BHVN) late Thursday gained regulatory approval for its migraine treatment drug to join the already competitive market sector, with the news sending its shares up 5.3% to $40.82 in after-hours trading, after falling 8.5% in the regular session.

The Food and Drug Administration has approved Biohaven’s Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. Nurtec ODT is the first FDA-approved product for Biohaven, a company dedicated to advancing innovative therapies for neurological diseases.

A single quick-dissolving tablet of Nurtec ODT can provide fast pain relief and return patients to normal function within one hour, and deliver sustained efficacy that lasts up to 48 hours for many patients. Nurtec ODT disperses almost instantly in a person's mouth without the need for water, offering people with migraine a convenient, discreet way to take their medication anytime and anywhere they need it. Nurtec ODT is not indicated for the preventive treatment of migraine. Biohaven expects top-line results from its prevention of migraine trial later this quarter.