Lipocine Inc (NASDAQ:LPCN) is considerably higher in mid-afternoon trading today, currently up 27 cents at $4.29 a boost of nearly seven percent. After the market close yesterday, the company released positive data from a dosing validation as well as a dosing flexibility study evaluating its testosterone replacement therapy (TRT).

The news has also sent Lipocines volume up today, as more than 7.4 million shares of the biotech have changed hands already. On a typical day, only about 164,000 shares of Lipocine end up getting traded.

The companys TRT, called LPCN 1021, was developed for adult males suffering from symptoms associated with a deficiency of endogenous testosterone a conditioned referred to as hypogonadism. According to Lipocines press release yesterday, the dosing validation and flexibility trials confirmed a fixed dose approach moving forward. Additionally, researchers will not need to do dose titration to orally administer the drug.

LPCN 1021 managed to successfully meet the FDAs regulations in the dosing validation study, as 81 percent of the enrolled patients hit average testosterone levels that fall within the normal range. In the dosing flexibility study, 70 percent of the trials subjects had average testosterone levels restored confirming a twice-per-day dosing regime for resubmission moving forward.

We are pleased with the confirmation of LPCN 1021 efficacy, especially with a more practical patient and physician preferred no titration dosing regimen, said the companys Chairman, President, and Chief Executive Officer, Dr. Mahesh Patel. We believe the results should address the label-related deficiency cited by the FDA in our NDA submission.

Dr. Patel told shareholders that he hopes that LPCN 1021 can be a differentiated TRT option for hypogonadism patients that will both improve patient compliance and reduce risk of testosterone interference. The company plans on resubmitting their New Drug Application (NDA) in the third quarter of the current year.

The author of this article holds no position in any of the companies mentioned above.

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Lipocine (LPCN) Spikes On Testosterone Dosing Data - Economic Calendar

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