BRIEF— Latest CRL leaves Lipocine with familiar feeling

US biopharma Lipocine lost 71% of its value in the stock market on Monday as markets digested news of a third complete response letter (CRL) relating to the testosterone replacement therapy, Tlando.

The US Food and Drug Administration (FDA) identified one deficiency in the CRL, stating that the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations.

Previous FDA rejection letters for Tlando, which is being developed for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, were issued in 2016 and 2018. They cited deficiencies related to the dosing algorithm for the label and a lack of data on whether the drug could lead to a clinically meaningful rise in blood pressure, respectively.