Lipocine Inc (NASDAQ:LPCN) has a date with FDA destiny today, as the agency prepares for its second glance at the drug maker’s twice-a-day oral testosterone product candidate TLANDO (once called LPCN 1021) created to help restore normal testosterone levels in hypogonadal men. Rejected two Junes ago, due to dosing algorithm deficiencies for the proposed label, one bull still wagers more clinical work must come to pass to win over the agency’s approval for Tlando. All eyes are watching today’s meeting closely.
Cannacord analyst Dewey Steadman notes that considering last week’s AdCom documents regarding the candidate’s oral testosterone therapy, he came away “both encouraged and disappointed.” Though safety looks superficially solid, Steadman believes Tlando approval is not in the bag just yet, specifically pointing to blood pressure and heart rate impacts that may require further evaluation.
Meanwhile, with rival Clarus “still on the horizon,” the analyst likewise keeps an eye on the competitor and its oral testosterone replacement therapy Jatenzo. Based on chats with the LPCN team, Steadman notes, “we were led to believe that Clarus was falling behind Lipocine in development of its oral testosterone therapy.”
“While we were disappointed by Clarus’ timing relative to Tlando, the Jatenzo documents appear highly negative related to CV issues like blood pressure and lipids; additionally Clarus’ potential TID dosing puts the product at a distinct disadvantage to Tlando’s BID dosing regimen, should both products be approved. If Tlando is approved, Clarus may initiate additional patent litigation actions that could modestly delay a Tlando launch,” continues the analyst.
Ultimately, Steadman concludes on a positive note: “While safety on the surface appears clean, Lipocine may have to conduct yet another trial to more deeply assess Tlando’s blood pressure and heart rate effects before potential approval. That said, it appears that competitor Clarus will have a tougher road to approval and may ultimately end up with an inferior product profile relative to Tlando. We eagerly anticipate Wednesday’s meeting and believe that Tlando could ultimately be approvable with adequate safety data in hand.”
Ahead of today’s meeting, the analyst reiterates a Buy rating on LPCN stock with an $11 price target, which implies a close to 218% upside from where the shares last closed. (To watch Steadman’s track record, click here)
TipRanks shows a bullish backing on this drug maker, with all 4 analysts polled in the last 12 months rating a Buy on Lipocine stock. The 12-month average price target stands at $21.00, boasting a nearly 507% upside from where the shares last closed.