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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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March 24, 2015
07:45 EDTSUPNFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 18, 2015
13:04 EDTSUPNSupernus management to meet with Piper Jaffray
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