Regulatory, Setbacks

Tiny Apricus’ survival strategy nixed for now by FDA rejection of erectile dysfunction therapy, shares crater

A little less than two years after tiny, San Diego-based Apricus Biosciences $APRI decided to cut its staff and concentrate the survivors on an erectile dysfunction cream called Vitaros, the microcap outfit has run into another brick wall.

Richard Pascoe

The FDA has handed the company a formal rejection, which Apricus says was triggered by CMC questions as well as “safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.”

Apricus shares went into meltdown mode, dropping 65%.

We’ll have to accept the biotech’s word on this as the only explanation we’ll get. FDA commissioner Scott Gottlieb welched on his promise to publish redacted CRLs and the agency is continuing its longterm policy of complete silence on these matters.

Apricus shares were put on hold ahead of the announcement Friday morning, but they can’t be helped by the regulatory stiff arm. The stock rose to a 5-year high ahead of the rejection, which still left Apricus with a market cap of only $48 million ahead of this morning’s collapse.

Apricus has cut back in the spring of 2016 after its lead testosterone drug fispemifene ran into trouble in a Phase IIb. The drug failed to beat out a placebo.

“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,” said Apricus CEO Richard Pascoe.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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