Lipocine Gets A Boost After News From The FDA

Lipocine Inc LPCN is a nano-cap specialty pharmaceutical company whose lead product candidate is an oral testosterone replacement therapy called LPCN 1021.

Shares of Lipocine were trading higher by more than 12 percent ahead of Monday's opening bell after the company announced the completion of a Post Action meeting with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its LPCN 1021 therapy.

The company noted that the purpose of its meeting with the FDA was to review the agency's Complete Response Letter (CRL), which was issued on June 28 and to discuss actions needed for approval of the therapy.

Related Link: Lipocine's Positive Patent Lawsuit News Not Enough To Lift The Stock

The FDA noted in its CRL that the company's proposed dosing regiment for LPCN 1021 might be acceptable, but validation in a clinical trial would be needed prior to re-submission.

Lipocine added in its press release that it is now submitted the new dosing validation clinical study protocol to the FDA and the FDA has agreed to review the protocol through a Special Protocol Assessment (SPA).

"We were pleased to have had a very productive meeting with the FDA with a path identified to bring our NDA for LPCN 1021 into a position for approval," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. "We remain committed to bring LPCN 1021 to the market."

At last check, Lipocine was up 1.58 percent at $3.86.

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