Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Other Events

ME Staff 8-k
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Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Other Events

Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Other Events
Item 8.01 Other Events.

On December5, 2018, Supernus Pharmaceuticals,Inc. (the “Company”) issued a press release announcing that the Company will report the results of its two pivotal Phase III studies of SPN-812 in children for the treatment of attention deficit hyperactivity disorder (“ADHD”) on Thursday, December6, 2018. A copy of this press releases is furnished as Exhibit99.1 hereto and is incorporated herein by reference.

On December6, 2018, the Company issued a press release announcing positive topline results from its Phase III studies of SPN-812 in children for the treatment of ADHD. The trial was successful in meeting the primary endpoint, demonstrating that SPN-812 at daily doses of 100mg and 200mg in study P301 and 200mg and 400mg in study P303 achieved a statistically significant improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-5. All SPN-812 doses tested in the trials were well tolerated. The Company expects to announce topline data from study P302, the first adolescent Phase III trial of SPN-812, by the end of December2018. Topline data from the second adolescent Phase III trial, P304, are expected by the end of the first quarter of 2019. The Company expects to submit a New Drug Application for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration approval, in the second half of 2020. A copy of this press release is furnished as Exhibit99.2 heretoand is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibit

The following document is furnished as an Exhibit to Item 8.01 hereof:

Exhibit99.1 — Press Release Dated December5, 2018.

Exhibit99.2 — Press Release Dated December6, 2018.

Exhibit99.3 — Presentation Slides.


SUPERNUS PHARMACEUTICALS INC Exhibit
EX-99.1 2 a18-41352_1ex99d1.htm EX-99.1 Exhibit 99.1     Supernus Schedules Conference Call to Present Topline Results of Two Phase III Studies for SPN-812 in Children with ADHD   ROCKVILLE,…
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About Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN)

Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company offers products for the treatment of epilepsy, which include extended-release oxcarbazepine (Oxtellar XR) and extended-release topiramate (Trokendi XR). It develops multiple product candidates in psychiatry for the treatment of Impulsive Aggression (IA) and attention deficit hyperactivity disorder (ADHD). Its psychiatry product candidates include SPN-810 (molindone hydrochloride) and SPN-812 (viloxazine hydrochloride). It is also developing SPN-810 as a treatment for IA in patients who have ADHD and SPN-812 for the treatment of ADHD. It is developing SPN-809 (viloxazine hydrochloride) for the treatment of depression. It markets its products in the United States through its own specialty sales force and has collaborations with other pharmaceutical companies to license its products outside the United States.