Neurocrine Bioscience, Inc. (NBIX) has received FDA approval for its branded drug Ingrezza (valbenazine) for the treatment of tardive dyskinesia, setting up a potential showdown just a week after Teva (TEVA) scored with their rival therapy, now approved for Huntington’s chorea.

Written by John Carroll (ENDpts.com)

Unlike Teva, Neurocrine’s label has come through without a black box warning on depression and suicidal ideation, giving it a distinct edge in any marketing confrontation to come as Teva waits for its own shot at the market. Neurocrine shares jumped…[19% on the news in after-market trading on Tuesday,] which was in line with expectations, though some analysts had fretted about the label.

The approval marks a sea change for San Diego-based NBIX, which has been building up a sales force for its first commercial launch. Analysts next want to see late-stage Tourette syndrome data on Ingrezza and NDAs for elagolix – partnered with AbbVie – in endometriosis and uterine fibroids as the biotech journeys through a transformative year.

Barclays, for one, has offered Neurocrine’s drug its stamp of blockbuster-worthiness, estimating peak sales at more than $1 billion for tardive dyskinesia alone. EvaluatePharma has also tracked a blockbuster future for this drug as well, designed to treat involuntary movements spurred by the prolonged use of antipsychotics. Huntington’s chorea is a related condition involving involuntary twisting and writhing.

Said CEO Kevin Gorman in a Tuesday evening call with analysts:

“This is a momentous occasion for us. Few companies can say they discovered a drug in their lab, developed it and grabbed an FDA approval. This is the first drug approved for TD [tardive dyskinesia].

What Gorman and his team didn’t say, though, was how much the drug will cost. Like a growing number of companies, Neurocrine wants a clean shot at celebrating the approval without having to explain the cost — a sensitive topic with manufacturers and payers. That will come with the launch, slated for May 1.