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November 21, 2012
05:03 EDTSUPNSupernus announces positive Phase 2b results on SPN-810, advances to development
Supernus Pharmaceuticals received positive top-line results from its Phase 2b study on SPN-810 for the treatment of impulsive aggression in ADHD patients. The study is a multi-center randomized, double-blind, placebo controlled clinical trial in children 6-12 diagnosed with Attention Deficit and Hyperactivity Disorder, or ADHD, and characterized by impulsive aggression that is not controlled by optimal stimulant and psychosocial treatment. A total of 121 patients were randomized in the study across placebo and three doses of SPN-810. SPN-810 was well tolerated throughout the study across all doses. The two serious adverse events that occurred were not drug related. The company will be analyzing the full data-set in depth, and subsequently planning on meeting with the FDA to discuss next steps in the development program and the design and protocol for Phase III clinical trials.
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August 21, 2014
07:38 EDTSUPNSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
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August 14, 2014
09:11 EDTSUPNOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Kohl's (KSS), up 2.5%... Plug Power (PLUG), up 10%... Perrigo (PRGO), up 4.5%. HIGHER: Aruba Networks (ARUN), up 3% after shares upgraded at Stifel... KaloBios (KBIO), up 7.9% after publication shows EphA3 as target for anticancer therapy... Supernus (SUPN), up 4.4% after receiving FDA fast track designation for SPN-810. DOWN AFTER EARNINGS: Noodles & Company (NDLS), down 22%... Vipshop (VIPS), down 5.8%. LOWER: ExOne (XONE), down 10.7%, Voxeljet (VJET), down 6.6%, after earnings reports. Peers in the 3D space are lower as well, with Stratasys (SSYS) down 1% and 3D Systems (DDD) down 0.2%... Enphase Energy (ENPH), down 2.6% after filing to sell common stock for holders... InterMune (ITMN), down 3% after downgraded at Goldman following yesterday's advance on Bloomberg report that the company received takeover bids from Sanofi (SNY), Roche (RHHBY).
07:37 EDTSUPNSupernus receives FDA fast track designation for SPN-810
Supernus Pharmaceuticals announced that the United States Food and Drug Administration has granted fast track designation for SPN-810 for the treatment of impulsive aggression in attention deficit hyperactivity disorder. This product candidate is expected to enter Phase III testing, with patient dosing commencing during 2015.
August 12, 2014
09:21 EDTSUPNOn The Fly: Pre-market Movers
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August 11, 2014
17:18 EDTSUPNSupernus raises FY14 revenue view to about $105M from $75M-$85M
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17:16 EDTSUPNSupernus reports Q2 EPS 8c, may not compare to consensus (16c)
Reports Q2 revenue $29.68M, consensus $19.85M.

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