Is It “Game Over” After Apricus Biosciences Inc (APRI) FDA Rejection?

The FDA has rejected approval of Apricus's Vitaros, leaving investors uncertain about the drug's future.

Apricus Biosciences Inc (NASDAQ:APRI) shares are collapsing today, down nearly 65%, following the news that the FDA has issued the company a complete response letter, rather than a green light to begin marketing its topical erectile dysfunction (ED) drug Vitaros.

The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control (CMC) and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.

Apricus CEO Richard W. Pascoe commented, “We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response letter with our regulatory experts, including the information that may be needed to resolve the deficiencies and the time it would take to obtain such information with the goal of providing the market an update on our assessment in early March of this year.”

Unquestionably, management’s reputation is on the line on Vitaros. Vitaros revenue is critical to keeping Apricus on firm financial footing, so most probably it will be all hands on deck to get this drug back in front of the FDA. Nevertheless, a shift in Vitaros launch is undeniably frustrating because, at a minimum, it means more quarters of shareholder-unfriendly cash burn.

H.C. Wainwright analyst Ram Selvaraju has recently reiterated a Buy rating on Apricus stock, with a price target of 4.50.

As usual, we recommend taking analyst notes with a grain of salt. According to TipRanks, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Ram Selvaraju has a yearly average return of -8.7% and a 32% success rate. Selvaraju is ranked #4705 out of 4761 analysts.


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