Lipocine Inc. /zigman2/quotes/202742746/lastsale LPCN -2.83% shares dropped 38% in premarket trade on Wednesday after the Food and Drug Administration failed to approve its testosterone replacement therapy. The product, Tlando, is the furthest along of Lipocine's three drug candidates. The FDA identified four deficiencies with Tlando's new drug application that affected its ability to approve it, Lipocine said. The company said it is assessing the decision, called a Complete Response Letter, and will work with the FDA to bring the product to patients. Lipocine shares have surged 44.7% over the last three months to $1.78, compared with a 2% rise in the S&P 500 /zigman2/quotes/210599714/realtime SPX -0.38% and a 0.7% rise in the Dow Jones Industrial Average /zigman2/quotes/210598065/realtime DJIA +0.27% .
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