Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Regulation FD Disclosure

Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.

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Supernus Pharmaceuticals,Inc. (the “Company”) makes the following disclosure:

Enrollment in the Phase III studies has progressed ahead of schedule on SPN-812, and is now complete in the P301, P302 and P303 studies with data expected in 4Q 2018. Enrollment in the P304 study is at approximately 76%. Data are still expected in 1Q 2019. The table below summarizes the studies and their status:


P301 N=432

P303 N=300

P302 N=300

P304 N=234

ADHD Patients

6-11 years

6-11 years

12-17 years

12-17 years

Total Daily Dose

100 – 200mg

200 – 400mg

200 – 400mg

400 – 600mg






Data Expected

4Q 2018

4Q 2018

4Q 2018

1Q 2019

Rollover from the Phase III trials to the open label extension remains at approximately 90%.

The Company continues to progress its plans to initiate the pivotal Phase III bipolar program in the second half of 2019. Recently, the Company completed certain activities, including market research and claims database analysis, on the use of oxcarbazepine in bipolar. The Company will be using information generated from these activities to finalize plans for the Phase III program. As a result, the Company deemed the investigator-initiated trial on Oxtellar XR in bipolar as no longer necessary, and has since stopped the study.

The Company is furnishing the foregoing information in this Current Report on Form8-K to comply with Regulation FD. Such information shall not be deemed to be “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.

This Current Report on Form8-K contains “forward-looking statements” that do not convey historical information, but relate to predicted or potential future events, such as statements of our plans, strategies and intentions. These statements can often be identified by the use of forward-looking terminology such as “believe,” “expect,” “intend,” “may,” “will,” “should,” or “anticipate” or similar terminology. All statements other than statements of historical facts included in this Current Report on Form8-K are forward-looking statements. All forward-looking statements speak only as of the date of this Current Report on Form8-K. Except for the Company’s ongoing obligations to disclose material information under the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In addition to the risks and uncertainties of ordinary business operations and conditions in the general economy and the markets in which the Company competes, the forward-looking statements of the Company contained in this Current Report on Form8-K are also subject various risks and uncertainties, including those set forth in Item1A, “Risk Factors,” in the Company’s Annual Report on Form10-K for the fiscal year ended December31, 2017 (as filed on March1, 2018), and in its subsequent filings made with the Securities and Exchange Commission.

Item 8.01 Other Events.

On August29, 2018, the Company issued a press release announcing that the Company’s management will present an overview and update of the Company’s business, and host investor meetings, at the 2018 Wells Fargo Healthcare Conference in Boston, MA on September5, 2018. A copy of this press release is furnished as Exhibit99.1 hereto and 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 August29, 2018.

EX-99.1 2 a18-26046_1ex99d1.htm EX-99.1 Exhibit 99.1     Supernus to Present at September 2018 Wells Fargo Healthcare Conference   ROCKVILLE,…
To view the full exhibit click here

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.

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