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Neurocrine Biosciences, Inc.

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eurocrine Provides Update on FDA Advisory Committee for INGREZZA™ (valbenazine) for the Treatment of Tardive Dyskinesia
Company to Host Conference Call and Webcast Today, January 5th at 4:30pm ET / 1:30pm PT
SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA), after further review of the INGREZZA™ (valbenazine) New Drug Application (NDA), has decided to cancel the Psychopharmacologic Drugs Advisory Committee meeting which was originally scheduled for February 16, 2017. The FDA informed the Company that the Priority Review of the NDA of INGREZZA for the treatment of tardive dyskinesia is continuing as planned with the previously announced Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017.

The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials along with the results from another 18 clinical trials; extensive preclinical testing and drug manufacturing data were included in the NDA submission. The FDA granted Breakthrough Therapy Designation to INGREZZA for tardive dyskinesia in 2014.

Conference Call and Webcast at 4:30 PM Eastern Time

Neurocrine will host a live conference call and webcast to discuss this press release on January 5, 2017 at 4:30 PM Eastern Standard Time (EST)/ 1:30 PM Pacific Standard Time (PST). Participants may access the live Conference Call by dialing 877-876-9175 (US) or 785-424-1668 (International) and using the conference ID: NBIX. The call can also be accessed via the Webcast through Neurocrine's website at http://www.neurocrine.com.

If you are unable to attend the webcast a replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 800-839-1229 (US) or 402-220-0459 (International) using the conference ID: NBIX. The call will be archived for one month.
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Source: press release, 1/05/17. http://phx.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=...

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Neurocrine Announces FDA Advisory Committee Meeting to Review INGREZZA™ (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia
Advisory Committee Meeting Scheduled for February 16, 2017
SAN DIEGO, Nov. 29, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in the New Drug Application (NDA) of INGREZZATM (valbenazine) for the treatment of tardive dyskinesia on February 16, 2017. The FDA has granted Priority Review status to the INGREZZA NDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017.

The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials which evaluated over 330 tardive dyskinesia patients. Data from these studies along with the results from another 18 clinical trials, extensive preclinical testing and drug manufacturing data were included in the NDA submission.
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Source: press release, 11/29/16. http://phx.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Valbenazine (NBI-98854) Tardive DyskinesiaPsychiatryTardive DyskinesiaVMAT2 inhibitorVMAT2

Mechanism of action: Valbenazine (NBI-98854) is a potent, highly selective, VMAT2 inhibitor that is effective in regulating the levels of dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines.

Phase of Development: Filed

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2017-02-16

Results: Discontinued