---

 

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

June 10, 2013

Date of Report (Date of earliest event reported)

Discovery Laboratories, Inc.

(Exact name of registrant as specified in its charter)

 

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 June 10, 2013, Discovery Laboratories, Inc. (the “Company”), announced that on June 7, 2013, it submitted its response to the U.S. Food and Drug Administration’s (FDA) recent correspondence relating to the Company’s recently updated product specifications for SURFAXIN^®.  The Company expects that the FDA may take up to four months to review the information provided.  If its plan is successful and the FDA agrees with the response, the Company expects to proceed with the commercial introduction of SURFAXIN in the fourth quarter of 2013.  A copy of the press release is attached hereto as Exhibit 99.1 and the text of such release is incorporated by reference herein.

The updated change in SURFAXIN product specifications is expected to have no impact on the Company’s development programs, including AEROSURF^®. The AEROSURF program currently remains on track for the initiation of phase 2 clinical program in the fourth quarter of 2013.

 

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits

99.1

Press release dated June 10, 2013

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 our product development, our plans regarding the anticipated commercial introduction of SURFAXIN and AEROSURF, the anticipated strategic alliance for the development and commercialization of SURFAXIN LS and AEROSURF 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.

 

---

 

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.

 

 

 

 

3

---