Cohen Milstein Sellers & Toll PLLC Announces the Investigation of Lipocine, Inc.

WASHINGTON--(BUSINESS WIRE)--Cohen Milstein Sellers & Toll PLLC is conducting an investigation to determine whether Lipocine, Inc. (“Lipocine” or the “Company”) and certain of its officers and directors made false and misleading statements and/or omissions in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

A class action lawsuit was filed in the U.S. District Court for the District of New Jersey by another law firm on behalf of purchasers of the common stock of Lipocine, Inc. (NASDAQ: LPCN) between February 27, 2015 and June 28, 2016, inclusive (the “Class Period”).

The complaint alleges that Lipocine and certain of its officers and directors (“Defendants”) misrepresented and/or failed to disclose that: (1) the Company improperly designed and implemented its new drug application (“NDA”) for LPCN 1021, an oral testosterone replacement therapy product candidate; (2) as such, the FDA would deny or delay approval of LPCN 1021; (3) as a result of the foregoing, the Company’s future revenues and viability would be jeopardized; and (4) the Company’s financial statements, as well as Defendants’ statements about Lipocine’s business, operations, and prospects, were false and misleading and/or lacked a reasonable basis.

The claims in this case arise from Defendants’ alleged failure to disclose problems in the Company’s NDA for LPCN 1021 that would result in the denial or delay of FDA approval. On November 12, 2015, Lipocine announced the FDA assigned a Prescription Drug User Fee Act goal date of June 28, 2016 for completion of the review of the NDA for LPCN 1021 and that an FDA Advisory Committee was not planned.

Prior to the market open on June 29, 2016, Lipocine reported that it had received a Complete Response Letter regarding its NDA for LPCN 1021 in which the FDA “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 between the Phase 3 trial and real-world clinical practice.” Management subsequently explained that in the trial the Company used 15 blood draws over a 24-hour period to adjust dosing. However, analysts noted that the proposed label for LPCN 1021 relied upon a single blood draw to determine appropriate dosage. The price of Lipocine shares fell from $6.27 to $3.10 on June 29.

Cohen Milstein encourages all investors who purchased Lipocine common stock between February 27, 2015 and June 28, 2016, or former employees with information concerning this matter to contact the firm.

If you are a Lipocine shareholder and would like to discuss your right to recover for your economic loss, you may, without any cost or obligation, call Cohen Milstein’s Managing Partner, Steven J. Toll at [phone] or [phone], or email him at [e-mail]. If you wish to serve as lead plaintiff, you must move the Court no later than August 30, 2016 to request appointment. Any member of the proposed class may retain Cohen Milstein or other attorneys to serve as your counsel in this action, or you may do nothing and remain an absent class member.

Cohen Milstein has significant experience in prosecuting investor class actions and actions involving securities fraud, and is active in major litigation pending in federal and state courts throughout the nation. Cohen Milstein has taken a lead role in numerous important cases on behalf of defrauded investors, and has been responsible for a number of outstanding recoveries which, in the aggregate, total over two billion dollars. Prior results do not guarantee a similar outcome. For more information visit www.cohenmilstein.com.

If you have any questions about this notice or the action, or with regard to your rights, please contact either of the following:

Steven J. Toll, Esq.
Robin Bleiweis
Cohen Milstein Sellers & Toll PLLC
1100 New York Avenue, N.W.
Suite 500 East
Washington, D.C. 20005
Telephone: [phone] or [phone]
Email: [e-mail]; [e-mail]

Attorney Advertising