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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

 

 

Date of Report (Date of earliest event reported): March 2, 2021

 

STRONGBRIDGE BIOPHARMA plc

(Exact name of registrant as specified in its charter)

 

Ireland

 

001-37569

 

98-1275166

(State or other
jurisdiction of incorporation)

 

(Commission
File Number)

 

(I.R.S. Employer
Identification No.)

 

900 Northbrook Drive, Suite 200
Trevose, PA

 

19053

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (610) 254-9200

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Ordinary shares, par value $0.01 per share

SBBP

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 

Emerging growth company         

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

Item 8.01Other Events

On March 2, 2021, the Company issued a press release announcing submission of a New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the treatment of endogenous Cushing’s syndrome to the U.S. Food and Drug Administration (FDA). A copy of the press release announcing these developments is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01                                           Financial Statements and Exhibits.

(d) Exhibits

Exhibit
Number

Exhibit Table

99.1

Press Release issued by Strongbridge Biopharma plc, dated March 2, 2021.

104

Cover Page Interactive Data File (formatted as inline XBRL).

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

STRONGBRIDGE BIOPHARMA PLC

 

 

 

By:

/s/ Stephen Long

 

Name:

Stephen Long

 

Title:

Chief Legal Officer

 

 

Date: March 2, 2021