1 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): November 22, 1999 GENELABS TECHNOLOGIES, INC. (Exact Name of Registrant as Specified in Charter) California 0-19222 94-3010150 (State or Other Jurisdiction (Commission File No.) (IRS Employer of Incorporation) Identification No.) 505 Penobscot Drive Redwood City, CA 94063 (Address of Principal Executive Offices) Registrant's telephone number, including area code: (650) 369-9500 2 ITEM 5. OTHER EVENTS On November 22, 1999, Genelabs Technologies, Inc. ("Genelabs") announced that GL701, its investigational drug for systemic lupus erythematosus, demonstrated a statistically significant advantage over placebo according to some analyses in patients with active disease. In a recent pre-NDA-meeting with the Food and Drug Administration ("FDA"), the FDA agreed that Genelabs' New Drug Application ("NDA") proposal appears adequate for submission; however, approval will be based on a complete review. The NDA will be based on the results of two pivotal Phase III clinical trials. The Registrant hereby incorporates by reference the press release attached hereto as Exhibit 99.1, and made a part of this Item 5. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS (c) EXHIBITS 99.1 Press Release, dated November 22, 1999 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. Genelabs Technologies, Inc. Dated: November 22, 1999 By: /s/ JAMES A.D. SMITH -------------------------------- James A.D. Smith President 2 3 EXHIBIT INDEX Exhibit Number Description - ------- ----------- 99.1 Press Release dated November 22, 1999 3