Lipocine Inc. Class Action Lawsuit
- Company Name
- Lipocine Inc.
- Stock Symbol
- Class Period
- March 27, 2019 to November 8, 2019
- District of Utah
On November 14, 2019, the Lipocine Inc. class action lawsuit was filed charging Lipocine and certain of its officers with violations of the Securities Exchange Act of 1934. The Lipocine class action lawsuit was commenced in the District of Utah on behalf of purchasers of Lipocine securities between March 27, 2019 and November 8, 2019 (the “Class Period”) and is captioned Abady v. Lipocine Inc., et al., No. 19-cv-00906.
Lipocine is a specialty pharmaceutical company focused on developing pharmaceutical products for men’s and women’s health. Lipocine’s lead product candidate is TLANDO (LPCN 1021), an oral testosterone replacement therapy. Lipocine has twice submitted New Drug Applications (“NDA”) for TLANDO to the U.S. Food and Drug Administration (“FDA”) and both times received Complete Response Letters (“CRL”) rejecting the NDAs. Lipocine received the first CRL in June 2016 and the second in May 2018. On March 27, 2019, Lipocine 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 Lipocine’s intention to refile the NDA for TLANDO in the second quarter of 2019.
The Lipocine class action lawsuit alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding Lipocine’s business and prospects. Specifically, defendants failed to disclose that the results from Lipocine’s clinical studies of TLANDO were insufficient to demonstrate the drug’s efficacy and, accordingly, Lipocine’s third NDA for TLANDO was reasonably likely to be found deficient by the FDA. As a result of this information being withheld from the market, Lipocine securities traded at artificially inflated prices during the Class Period, with Lipocine’s stock price reaching a high of more than $3.25 per share.
Then on November 11, 2019, Lipocine 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 its NDA for TLANDO – this time because an efficacy trial had not met three of its secondary endpoints. On this news, the price of Lipocine stock fell $1.93 per share, or more than 70%, to close at $0.80 per share on November 11, 2019.
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