Bragar Eagel & Squire, P.C., a nationally recognized shareholder law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the District of Utah on behalf of investors that purchased Lipocine, Inc. (NASDAQ: LPCN) securities between March 27, 2019 and November 8, 2019 (the "Class Period"). Investors have until January 14, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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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, 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.
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 Complaint, filed on November 14, 2019, 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.
If you purchased Lipocine securities during the Class Period, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at firstname.lastname@example.org, or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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