Neurocrine Biosciences Wins Big With FDA Approval

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Neurocrine Biosciences Inc. (NASDAQ: NBIX) saw its shares jump after the company reported a key U.S. Food and Drug Administration (FDA) approval. Specifically, the agency approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). Ingrezza is the first and only FDA-approved product indicated for the treatment of adults with TD.

Recent clinical studies have shown that Ingrezza provides significant, rapid and meaningful improvement in TD signs and symptoms versus the placebo through six weeks, with continued reductions in TD observed through 48 weeks of treatment.

Ingrezza was generally well tolerated, with somnolence as the only adverse event occurring at a rate greater than or equal to 5% and twice placebo. In clinical trials, no worsening in safety scale scores for depression, suicidal ideation or behaviors was observed. The drug has been studied in over 1,000 individuals and more than 20 clinical trials.

Management ultimately hopes that with this FDA approval, this is a step toward mental health conditions being destigmatized, and hopefully this will lead to more productive and proactive conversations between individuals and doctors regarding TD.

Kevin C. Gorman, CEO of Neurocrine Biosciences, commented:

The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. The approval of INGREZZA represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope. For the past 20 years, Neurocrine has been devoted to developing treatments for difficult to manage conditions in underserved patient populations. We are committed to ensuring that those impacted by the disruptive effects of TD have access to Ingrezza.

Some background on TD: It is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities or face. The condition is caused by treatments that block dopamine receptors in the brain, such as antipsychotics and other medications, which are commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression.

Shares of Neurocrine were last seen up 22% at $50.69 on Wednesday, with a consensus analyst price target of $67.33 and a 52-week trading range of $37.35 to $55.15.