Lipocine Inc LPCN is still down 57 percent since the U.S. Food and Drug Administration’s Bone, Reproductive and Urologic Drugs Advisory Committee voted 6-13 on Tlando’s benefit-risk profile.
But one Street analyst is not only undeterred but is encouraged by the drug’s prospects.
Empire Asset Management’s Dr. Cathy Reese upgraded Lipocine from Hold to Buy with a $21 price target.
Lipocine decided to initiate FDA-requested trials addressing blood pressure and phlebotomy concerns ahead of the extended May 8 Prescription Drug User Fee Act date. Reese, who acknowledged rumors that Lipocine was investigating the validity of such demands, also questioned the legitimacy of the requests in a Monday note.
“The FDA has not requested other approved testosterone product sponsors to complete ambulatory blood monitoring trials prior to their approvals, and LPCN’s clinical trial results do not seem to justify a request,” Reese said in a Tuesday note.
If the demands are upheld and Lipocine must complete trials ahead of approval, the PDUFA review cycle would restart and create delays. Reese is confident in the drug’s potential.
“We believe that Tlando has a high probability of gaining an approval, whether it is on the PDUFA date or once the blood pressure and collection test tube clinical data is generated and reviewed, which we believe should occur in 2018."
At the time of publication, Lipocine was trading up 13.74 percent at $1.49.
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