May 26, 2020 - An amended complaint was filed.

November 14, 2019 - An investor in shares of Lipocine Inc. (NASDAQ: LPCN) filed a lawsuit in the U.S. District Court for the District of Utah over alleged violations of Federal Securities Laws by Lipocine Inc. in connection with certain allegedly false and misleading statements made between March 27, 2019, and November 8, 2019.

Salt Lake City, UT based Lipocine Inc., a specialty pharmaceutical company, focuses on the development of pharmaceutical products in the area of men's and women's health. Its primary development programs are based on oral delivery solutions for poorly bioavailable drugs. Lipocine Inc’s lead product candidate is TLANDO (LPCN 1021), an oral testosterone replacement therapy. The Company has previously submitted New Drug Applications (“NDA”) for TLANDO twice and, both times, received Complete Response Letters (“CRL”) from the U.S. Food and Drug Administration (“FDA”) rejecting the NDAs. The Company received the first CRL in June 2016 and the second in May 2018.

On March 27, 2019, during pre-market hours, Lipocine Inc announced new topline results from a study evaluating TLANDO’s effects on blood pressure (one issue cited by the FDA in a prior CRL rejecting TLANDO’s NDA), as well as the Company’s intention to refile the NDA for TLANDO in the second quarter of 2019 (the “March 2019 Press Release”).

On November 11, 2019, Lipocine Inc announced the receipt of a CRL from the FDA regarding its NDA for TLANDO. In the press release, Lipocine advised investors that the FDA had again rejected the NDA for TLANDO—this time because an efficacy trial had not met three of its secondary endpoints. Shares of Lipocine Inc (NASDAQ: LPCN) declined from $3.21 per share in October 2019 to as low as $0.38 per share on November 14, 2019.

According to the complaint the plaintiff alleges on behalf of purchasers of Lipocine Inc. (NASDAQ: LPCN) common shares between March 27, 2019, and November 8, 2019, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between March 27, 2019, and November 8, 2019, the defendants made false and/or misleading statements and/or failed to disclose that the results from Lipocine’s clinical studies of TLANDO were insufficient to demonstrate the drug’s efficacy, that accordingly, Lipocine’s third NDA for TLANDO was highly likely to be found deficient by the FDA, and that as a result, the Company’s public statements were materially false and misleading at all relevant times.