UPDATE 1-FDA rejects Lipocine's testosterone drug for third time

The U.S. Food and Drug Administration on Monday declined to approve Lipocine Inc’s oral drug to treat a condition that results in lower production of male sex hormone for the third time, sending the drug developer’s shares down 34%. The company said a letter from the regulator indicated the application could not be approved in its present form as Lipocine’s trial did not meet three secondary goals that were designed to assess if higher levels of testosterone in patients could raise safety concerns. The decision marks the third regulatory setback in over three years for Lipocine’s Tlando, which aims to restore normal testosterone levels in men with deficiency or absence of testosterone.