8-K 1 v034214.htm Unassociated Document
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
 
January 26, 2006
Date of Report (Date of earliest event reported)
 
Discovery Laboratories, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
000-26422
94-3171943
(State or other jurisdiction
of incorporation)
(Commission File Number)
(IRS Employer
Identification Number)
 
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976
(Address of principal executive offices)
 
(215) 488-9300
(Registrant's telephone number, including area code)
 
(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:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 

 
 
Item 8.01.    Other Events.

On January 26, 2006, Discovery Laboratories, Inc. (the “Company”) issued a press release announcing that the United States Food and Drug Administration has granted Fast Track designation to the Company’s lead product, Surfaxin®, for the prevention and treatment of Bronchopulmonary Dysplasia (“BPD”) in premature infants. Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug means that the FDA has determined that the drug is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address unmet medical needs for such a condition, and that the FDA will facilitate and expedite the development and review of the application for the approval of the product. The Company is currently conducting a Phase 2 clinical trial to determine the safety and tolerability of administering Surfaxin as a therapeutic approach for the prevention and treatment of BPD. Results from this study are expected in 2006. The press release, dated January 26, 2006, is filed as Exhibit 99.1 to this report and is incorporated herein by reference.
 
Item 9.01.    Financial Statements and Exhibits.
 
  (d)  Exhibits  
       
   
99.1
Press release, dated January 26, 2006.
 
Cautionary Note Regarding Forward-looking Statements:

To the extent that statements in this Current Report on Form 8-K are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company’s product development or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this Current Report are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Such risks and others are further described in the Company's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
 
 
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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.

     
  Discovery Laboratories, Inc.
 
 
 
 
 
 
  By:   /s/ Robert J. Capetola  
 
Name: Robert J. Capetola, Ph.D.
  Title: President and Chief Executive Officer
   
Date: January 30, 2006  
 
 
 
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