NEW YORK, NY / ACCESSWIRE / December 31, 2019 / Pomerantz LLP announce that a class action lawsuit has been filed against Lipocine Inc. ("Lipocine" or the "Company") (LPCN) and certain of its officers. The class action, filed in United States District Court, for the District of Utah, and docketed under 19-cv-00906, is on behalf of a class consisting of investors who purchased or otherwise acquired Lipocine securities between March 27, 2019, and November 8, 2019, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Lipocine common shares within the Class Period, you have until January 14, 2020, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and number of shares purchased.
Lipocine is a specialty pharmaceutical company that focuses on the development of pharmaceutical products in the area of men's and women's health. The Company's primary development programs are based on oral delivery solutions for poorly bioavailable drugs. The Company has a portfolio of product candidates purportedly designed to produce pharmacokinetic characteristics and facilitate lower dosing requirements, bypass first-pass metabolism in certain cases, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability.
Lipocine'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 issued a press release announcing 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").
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the results from Lipocine's clinical studies of TLANDO were insufficient to demonstrate the drug's efficacy; (ii) accordingly, Lipocine's third NDA for TLANDO was highly likely to be found deficient by the FDA; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.
On November 11, 2019, Lipocine issued a press release announcing 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.
On this news, Lipocine's stock price fell $1.93 per share, or 70.7%, to close at $0.80 per share on November 11, 2019.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
SOURCE: Pomerantz LLP
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