Neurocrine Biosciences (NBIX) Announces Submission of Valbenazine NDA as Tardive Dyskinesia Treatment
- Wall St stumbles as FBI to review more Clinton emails
- FBI to review more emails related to Clinton's private email use
- Unusual 11 Mid-Day Movers 10/28: (GRVY) (VRTS) (ITGR) Higher; (OPXA) (SNMX) (STON) Lower
- ExxonMobil (XOM) Tops Q3 EPS by 5c; CapEx Light of Views
- Baker Hughes (BHI), General Electric (GE) in Partnership Talks, Not Merger Talks
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily dosing of valbenazine in treating tardive dyskinesia.
"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 C. Gorman, President and Chief Executive Officer 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."
The NDA for valbenazine 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. The Company expects to receive notification of the acceptance of the NDA, as well as the timeframe for NDA review from the FDA in October 2016.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Neurocrine Biosciences (NBIX): Increasingly Bullish on Valbenazine - BMO
- Sanofi (SNY) Alerts Regeneron (REGN) of FDA Concerns Related to Sarilumab Manufacturing Facility
- GATX Corp. (GATX) Adds Ryan Specialty Group's Aigotti as Director
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!