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): July 21, 2017

 

NEKTAR THERAPEUTICS

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware   0-24006   94-3134940

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

 

 

 

455 Mission Bay Boulevard South

San Francisco, California 94158

(Address of Principal Executive Offices and Zip Code)

 

Registrant’s telephone number, including area code: (415) 482-5300

 

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))

 

 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 o

 

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 8.01. Other Events.

 

On July 21, 2017, Nektar Therapeutics, a Delaware corporation (“Nektar”), was informed by the European Medicines Agency’s Committee for Medicinal Products for Human Use (the “CHMP”) that it has adopted a negative opinion for the conditional marketing authorization application for ONZEALDTM in the European Union (the “MAA”). Nektar intends to appeal the CHMP opinion and immediately seek a re-examination of the opinion by the CHMP. Nektar and Daiichi Sankyo Europe GmbH will continue to collaborate on ONZEALDTM during the re-examination process.

 

 
 

 

 

 

SIGNATURES

 

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

 

 

 

       
  By: /s/ Mark A. Wilson  
    Mark A. Wilson  
    General Counsel and Secretary  
       

Date: July 21, 2017