Approval For Neurocrine’s Ingrezza Was No Surprise, But Lack Of Warning Label A Big Advantage Over Teva

Neurocrine Biosciences, Inc. NBIX 0.35% investors got a pleasant surprise when the FDA approved the company’s Ingrezza drug for treatment of tardive dyskinesia (TD).

While the approval itself was expected, Baird analyst Brian Skorney says the FDA’s generous labeling puts the drug at a major advantage to Teva Pharmaceutical Industries Ltd (ADR) TEVA 0.47%’s rival drug Austedo.

Baird was concerned about the FDA adding a potential black box warning related to suicidality, but the FDA opted for no such warning.

“With Teva’s Austedo approved just last week with a warning and what is likely to be a higher price, we’re confident Ingrezza can prevail as the leader in TD even if Austedo is eventually approved,” Skorney explains.

Traders certainly recognize the Ingrezzas advantageous position. Shares of Neurocrine are up more than 23 percent on Wednesday.

Ingrezza will be available at specialty pharmacies within a week’s time, but Skorney says the company is expected to launch a full-scale sales effort starting on May 1.

Skorney expects news related to drug pricing before the end of the month. Baird predicts…

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