AUA 2016: Studies Suggest Safety Ahead Of Lipocine's Oral Testosterone PDUFA
While Lipocine Inc. is at the nail-biting stage of development for its oral testosterone Tlando (LPCN 1021) – awaiting a US FDA approval decision – urologists continue to study testosterone therapy to determine whether treatment of hypogonadal men is safe with appropriate monitoring.
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The FDA on 3 March said it was imposing new warnings on the labeling of testosterone replacement therapies (TRTs), like AbbVie's $1bn drug AndroGel, about an increased risk of heart attack and stroke.
Top-line results from the pivotal Phase III SOAR trial of Lipocine's oral testosterone product LPCN 1021 in hypogonadal men with low testosterone (Low T) show that it met its primary endpoint of getting serum hormone levels back to normal. Lipocine expects to file a new drug application (NDA) with the US FDA in the second half of 2015.
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.