Lipocine Receives Letter From FDA

Lipocine Inc. (LPCN) has received a Complete Response Letter or CRL from the FDA regarding the company’s New Drug Application for TLANDO, an oral testosterone product candidate. The FDA has stated that the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations.

“We are disappointed by the FDA’s decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of TLANDO,” said Mahesh Patel, CEO of Lipocine.

Shares of Lipocine Inc. were down nearly 34% in pre-market trade on Monday.-Nasdaq