Lipocine Inc.

Robbins Arroyo LLP: Lipocine, Inc. (LPCN) Misled Shareholders According to a Recently Filed Class Action

Robbins Arroyo LLP announces that a class action complaint was filed against Lipocine, Inc. (NASDAQCM: LPCN) in the U.S. District Court for the District of New Jersey. The complaint is brought on behalf of all purchasers of Lipocine securities between June 30, 2015 and June 28, 2016, for alleged violations of the Securities Exchange Act of 1934 by Lipocine’s officers and directors. Lipocine, a specialty pharmaceutical company, develops pharmaceutical products using its oral drug delivery technology in the areas of men’s and women’s health. The company’s lead product candidate, TLANDO (“LPCN 1021″) is an oral testosterone replacement therapy designed for twice-a-day dosing.

Lipocine Accused of Misrepresenting Its Lead Product Candidate

According to the complaint, on June 29, 2015, Lipocine issued a press release announcing the results of its Phase 3 clinical study evaluating the efficacy and safety of LPCN 1021. Lipocine officials detailed that they were pleased with LPCN 1021′s safety profile, that LPCN 1021 was well tolerated during 52 weeks of dosing, and that there were no reported serious adverse events. Lipocine further elaborated that it expects to file a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) in the second half of 2015. On August 31, 2015, the company issued a press release announcing the submission of the NDA for LPCN 1021 to the FDA, calling it a significant achievement for Lipocine and a major milestone toward bringing the potential testosterone replacement therapy to patients. On October 29, 2015, Lipocine announced that the FDA had accepted its NDA for LPCN 1021, and subsequently submitted several filings with the U.S. Securities and Exchange Commission stating the same.

The complaint alleges that these statements were misleading because they failed to disclose that Lipocine’s filing of its NDA for LPCN 1021 contained deficiencies. On June 29, 2016, the company issued a press release disclosing its receipt of a Complete Response Letter (“CRL”) for LPCN 1021 from the FDA, stating that the CRL identified deficiencies related to the dosing algorithm for the label. Specifically, the proposed titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial, leading to discordance in titration decisions. On this news, Lipocine stock fell $3.17 per share, or over 50%, to close at $3.10 per share on June 29, 2016.

Lipocine Shareholders Have Legal Options

Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.

 

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