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 February 23, 2001 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 (Commission File Number) (IRS Employer of incorporation) Identification Number) 350 Main Street, Suite 307 Doylestown, Pennsylvania 18901 (Address of principal executive offices) (215) 340-4699 (Registrant's telephone number, including area code) (Former name or former address, if changed since last report) 1 Item 5. Other Events On February 23, 2001, the Registrant issued a press release addressing the Registrant's proposed plans to conduct a Phase 3 clinical trial of Surfaxin(R) in Latin America for the treatment of idiopathic respiratory distress syndrome (IRDS) in premature newborns. Item 7. Financial Statements, Pro Forma Financial Statements and Exhibits (c) Exhibits: 99.1 Press Release dated February 23, 2001. 2 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, Ph.D. -------------------------------------- Name: Robert J. Capetola, Ph.D. Title: President and Chief Executive Officer Date: March 2, 2001 3