Neurocrine Biosciences Achieves Best Case Scenario With Ingrezza Approval

BMO Capital Markets picked Neurocrine Biosciences, Inc.. NBIX to Outperform expectations on Wednesday, one day after the the U.S. Food and Drug Administration approved the pharmaceutical company’s drug for the treatment of tardive dyskinesia, a neurological disorder.

It was the first drug the FDA has ever approved for the condition, which the agency said is characterized by “repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips.”

Neurocrine shares were through the roof in early trading Wednesday, up nearly 25 percent.

BMO said the drug Ingrezza (valbenazine) has “potential for higher pricing points to upside to our $2.5 billion.”

“We maintain our $72 price target but believe three near-term events could support upside to $100,” BMO said, citing the price of the drug, its effectiveness against the competition, and its potential use to treat pediatric Tourette’s Syndrome.

Drug Treats Side Effects Of Other Drugs

The FDA said tardive dyskinesia is a serious side effect sometimes seen in patients who have been treated with antipsychotic medications for conditions such as schizophrenia and bipolar disorder. Tardive dyskinesia can also occur in patients taking antipsychotic medications for depression and certain medications for gastrointestinal disorders and other conditions.

The FDA said efficacy of Ingrezza was shown in a clinical trial of 234 participants that compared Ingrezza to a placebo. After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements compared to those who received a placebo.

"Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness," said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition."

The stock traded recently at $50.69, up about 21 percent.