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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): September 21, 2019
OPKO Health, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware
 
001-33528
 
75-2402409
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

4400 Biscayne Blvd.
Miami
Florida
 
33137
(Address of Principal Executive Offices)
 
(Zip Code)
Registrant’s telephone number, including area code: (305575-4100
Not Applicable
Former name or former address, if changed since last report
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
Common Stock
OPK
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.    o
 





ITEM 7.01.
 
Regulation FD

On September 21, 2019, OPKO Health, Inc. (the “Company”) presented four year results from a phase 2 extension study for once weekly Somatrogon (hGH-CTP) in a poster presentation at the 58th Annual Meeting of the European Society for Paediatric Endocrinology, held in Vienna Austria. The data presented included long term safety and efficacy results from the Company’s phase 2 open label extension study in children with Growth Hormone Deficiency.

A copy of the poster, entitled “Long-Term Safety of a Once-Weekly Somatrogon (hGH-CTP): 4-Year Results of a Phase 2 Extension Study in Children with Growth Hormone Deficiency”, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information included herein and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

ITEM 9.01.
 
Financial Statements and Exhibits.
 
(d)
Exhibits
Exhibit No.
 
Description
 
 
99.1
 
Poster presented at 58th Annual Meeting of the ESPE







Exhibit Index

 
 
 
Exhibit No.
 
Description
 
 
99.1
 







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.

 
 
OPKO Health, Inc.
 
 
 
 
 
 
By:
/s/ Adam Logal
Date: September 23, 2019
 
Name:
Adam Logal
 
 
Title:
Senior Vice President, Chief Financial Officer