Shares of Impel NeuroPharma (IMPL -0.34%) are shooting higher in response to Food and Drug Administration approval of the company's first drug. Investors excited about the company's graduation to commercial-stage status pushed the stock 22.3% higher as of 11:18 a.m. EDT on Friday.
On Friday morning, the FDA approved Trudhesa, a new nasal spray made with an old migraine drug called dihydroergotamine mesylate. This is an especially big deal for Impel NeuroPharma because previously the company didn't have any means of generating revenue.
Impel NeuroPharma's first drug launch, to begin in October, could be a big one. Around 19 million Americans are diagnosed with migraines, but less than one in four are on treatment.
Trudhesa is the first therapy to use Impel Neuropharma's nasal delivery system. It isn't the first nasal dihydroergotamine treatment available for millions of Americans who frequently suffer from painful migraine headaches.
Bausch Health (BHC 0.26%) markets Migranal, a nasal spray containing dihydroergotamine and caffeine for the treatment of the same migraine patients as Trudhesa. Migranal sales came in under $30 million last year, so it's hard to imagine Impel NeutoPharma's new sales team doing much better.
Trudhesa is a lower dosage delivered once per nostril while Migranal needs to be administered twice per nostril over a 15-minute period. Since Trudhesa was approved based on bioequivalence with Migranal, we don't know if Trudhesa's lower dosage provides significant benefits over the original. With so many important questions left to answer, it's probably best to watch this biotech stock from a safe distance.