AbbVie Inc (ABBV), AstraZeneca plc (ADR) (AZN): Neurocrine Biosciences, Inc. (NBIX) Nosedives on Mid-Stage Study Results

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Investors hate to wake up and find that one of their stocks has opened nearly 30% lower than the prior day’s close. Unfortunately, that’s exactly what happened on Tuesday for Neurocrine Biosciences, Inc. (NASDAQ:NBIX). The biopharmaceutical company announced bad news from a phase 2 study of experimental movement disorders drug NBI-98854. Here’s what happened and what could be in store for Neurocrine now.

Dissecting the results
NBI-98854 inhibits the vesicular monoamine transporter 2, or VMAT2, protein. The drug modulates the release of dopamine from the brain. Neurocrine Biosciences, Inc. (NASDAQ:NBIX) thinks that inhibiting VMAT2 could reduce the affects of tardive dyskinesia, a disorder that involves involuntary body movements.

However, the company said that the 50 mg dose of NBI-98854 didn’t meet the clinical study’s primary endpoint of change-from-baseline in the Abnormal Involuntary Movement Scale, or AIMS, after six weeks. The AIMS assessment is designed to detect and track the severity of tardive dyskinesia.

Neurocrine Biosciences, Inc. (NASDAQ:NBIX)This phase 2b study initially included 109 patients with tardive dyskinesia. Patients were initially separated into three groups — one group taking placebo, a group taking a 50 mg dose of NBI-98854, and a third group taking a 100 mg dose of the drug. While the 50 mg dosage didn’t show any statistical improvement compared to placebo, Neurocrine Biosciences, Inc. (NASDAQ:NBIX) said that patients taking the 100 mg dose did experience meaningful reduction in symptoms in the second week of the study.

Based on these results, Neurocrine Biosciences, Inc. (NASDAQ:NBIX) now plans to an additional phase 2 study using 100 mg and higher dose levels. The company had expected the 100 mg dose to be a maximum tolerated dose based on earlier results. However, this latest study showed that patients tolerated the higher dose relatively well. There were no serious drug-related adverse events, and the overall frequency and severity of adverse events was lower than expected.

The bigger picture
Neurocrine Biosciences, Inc. (NASDAQ:NBIX)’s stock got hit hard by this disappointing news. However, the results for the 100 mg dose at least give investors some hope that NBI-98854 could still achieve success.

The even better news for Neurocrine Biosciences, Inc. (NASDAQ:NBIX), though, is that it isn’t relying solely on the VMAT2 inhibitor. The company has two studies under way for elagolix with partner AbbVie Inc (NYSE:ABBV).

One of those studies, targeting treatment of endometriosis pain, is in phase 3. AbbVie Inc (NYSE:ABBV) and Neurocrine Biosciences, Inc. (NASDAQ:NBIX) expect to announce top-line results in the third quarter of 2014. The partners also have a phase 2 clinical trial in process with elagolix targeting treatment of uterine fibroids.

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