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