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 11, 2014

 

 

 

ROCK CREEK PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

(State or other jurisdiction of incorporation)

000-15324

(Commission File Number)

52-1402131

(IRS Employer Identification No.)

     
 

2040 Whitfield Avenue, Suite 300

Sarasota, Florida 34243

(Address of principal executive offices, including zip code)

 

(804) 527-1970

(Registrant’s telephone number, including area code)

 
     

 

 

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))

 

 
 

 

Item 8.01.Other Events.

 

Attached as Exhibit 99.1 to this Current Report on Form 8-K is a press release issued by Rock Creek Pharmaceuticals, Inc. on July 11, 2014.

 

Item 9.01.Financial Statements and Exhibits.

 

   (d)Exhibits.

 

Exhibit No.Description

 

99.1Press release, dated July 11, 2014.

 

 

 
 

  

SIGNATURE

 

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.

 

 

  ROCK CREEK PHARMACEUTICALS, INC.
   
   
  By:  /s/ Michael J. Mullan
    Michael J. Mullan
Chairman of the Board and Chief Executive Officer

 

Date: July 11, 2014

 

 



Exhibit 99.1

 

Rock Creek Pharmaceuticals Issues Update On

US Investigational New Drug Application

 

 

Sarasota, FL. July 11, 2014 /PRNewswire/ Rock Creek Pharmaceuticals, Inc. (NASDAQ: RCPI), an emerging biotechnology company, today announced that the Food and Drug Administration (“FDA”), has notified the Company that the agency will provide comments on RCP’s Investigational New Drug (“IND”) application before granting the Company permission to start its clinical trial in the US.

 

Dr. Chris Chapman, RCP’s President, commented, “We appreciate the agency’s review and comments on our IND. When we receive the agency’s official comments and/or recommendations, we will respond expeditiously. We look forward to moving this important product through the regulatory process.”

 

Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical dietary supplements products, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices and the outcome of the ongoing investigations as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2013 filed on March 17, 2014. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

 

About Rock Creek Pharmaceuticals, Inc.

 

Rock Creek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for inflammatory conditions, clinical immunology, neurological disease and behavioral health. Additionally, through its subsidiary RCP Development, the Company is engaged in the manufacturing and sale of nutraceutical dietary supplements designed to promote maintenance of a healthy metabolism and lifestyle. 

 

For more information, visit: http://www.rockcreekpharma.com

 

CONTACT:

Ted Jenkins
Vice President, Corporate Strategy, Development, Investor Relations
Rock Creek Pharmaceuticals
tjenkins@rockcreekpharma.com

 

 

 

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