Neurocrine submits valbenazine NDA early, set for 2017 approval

Neurocrine Biosciences ($NBIX) has sent off an NDA for its experimental med earlier than analysts had reckoned as it seeks U.S. approval for treating twitches of the face and jaw.

Specifically, the San Diego, CA-based biotech said it has submitted the once-daily valbenazine to the FDA for tardive dyskinesia.

The company said it expects its submission to be accepted by October, giving it an expected PDUFA date in April, should it get an accelerated review--it has already received a "breakthrough" designation from the FDA.


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Its drug is a VMAT2 inhibitor that modulates dopamine release during nerve communication. It is designed to treat tardive dyskinesia, a condition characterized by involuntary, repetitive movements of the face.  

The biotech said that these symptoms are rarely reversible and there are currently no FDA-approved treatments.

Baird analyst Brian Skorney said in a note to clients that Neurocrine remained on an “outperform” rating as the NDA came a little earlier than expected.

The news gets better for Neurocrine, as partner AbbVie ($ABBV) is also on track to file their investigational endometriosis drug elagolix for its U.S. NDA next year.

“This is an important milestone in the development of valbenazine for the treatment of tardive dyskinesia, a serious disease for which there is no FDA approved pharmaceutical treatment,” said Kevin Gorman, president and CEO of Neurocrine Biosciences.

“We look forward to working with the FDA in their review of the valbenazine NDA submission to potentially bring this important treatment option to patients and physicians.”

But it’s not always been good news for the biotech as back in June of last year it announced that it suspended two planned clinical studies of its CRF antagonist NBI-77860 out of “an abundance of caution.”

This came after the company said it had found “certain recent preclinical findings that we had not observed in previous animal studies.”

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