We are investigating Lipocine Inc. (LPCN) (“Lipocine” or the “Company”) for potential violations of the federal securities laws.
On November 11, 2019, Lipocine announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration regarding its New Drug Application for TLANDO, Lipocine’s product candidate for testosterone replacement therapy. Lipocine advised investors, inter alia, that “[t]he CRL identified one deficiency stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations.” On this news, Lipocine’s stock price fell sharply during intraday trading on November 11, 2019.