Lipocine Inc (LPCN) Fails to Convince FDA Advisory Committee of TLANDO’s Merit; Shares Decline Over 50%


Lipocine Inc (NASDAQ:LPCN) failed to convince the Food and Drug Administration advisory committee that its phase 3 data testing TLANDO in hypogonadal male patients was good enough to award the drug an approval. Lipocine shares reacted accordingly, crashing nearly 56%.

The final vote came in at 6 to 13 recommending the FDA not approve the drug. The FDA doesn’t have to follow the panel’s advice, but given the negative tone, it seems highly unlikely the agency would go against the negative recommendation. The FDA decision is anticipated by the assigned Prescription Drug User Fee Act (“PDUFA”) goal date of May 8, 2018.

“We continue to believe that efficacy and safety results from numerous clinical studies with TLANDO are consistent with other FDA approved TRT products,” said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.  “We look forward to continuing to work with the FDA through the remainder of the review process.”

On the ratings front, Lipocine has been the subject of a number of recent research reports. In a report issued on January 8, Canaccord  analyst Dewey Steadman assigned a Buy rating on LPCN, with a price target of $11, which implies an upside of 218% from current levels. Separately, on December 8, H.C. Wainwright’s Oren Livnat assigned a Buy rating to the stock and has a price target of $10.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Dewey Steadman and Oren Livnat have a yearly average loss of 0.7% and 5.8% respectively. Steadman has a success rate of 43% and is ranked #3670 out of 4739 analysts, while Livnat has a success rate of 35% and is ranked #4222.

Lipocine, Inc. engages in the research and development of treatment for use in men’s and women’s health through proprietary drug delivery technologies. It focuses on oral testosterone replacement therapy and preterm birth prevention. The company was founded on July 24, 2013 and is headquartered in Salt Lake City, UT.