Amicus Therapeutics, Inc. (NASDAQ: FOLD)

Amicus Therapeutics, Inc. (FOLD), a biopharmaceutical company yesterday announced that its request for quick approval for its Fabry drug Galafold has been denied by the U.S. Food and Drug Administration. The denial means the drug will face an extended delay of at least 2 years. Amicus now plans to start a new study in 2017 but won’t see any clinical data results until at least 2019.  

Amicus Therapeutics, Inc. CEO’s Comments

"While we believe that the totality of the data from our studies with migalastat [Galafold] support the submission of a new drug application today, we acknowledge the FDA's position that accelerated approval based on kidney GL-3 reduction is not currently an option," said Amicus CEO John Crowley, in a statement.

"We have thus defined a plan to collect additional GI data to support full approval for migalastat that we believe is feasible in a reasonable amount of time and with a high likelihood of success based on positive GI data generated in our previous Phase 3 Study 011."  The Street

FOLD Technical Analysis

FOLD opened trading yesterday at $8.80 which was down from the previous day’s trading close of $8.90. FOLD closed trading yesterday at $8.32 and crashed down after market to $6.10, equivalent to a 27% decrease from the closing price. Taking a look at the daily chart we can see that the last time FOLD traded below these levels we have to go back to the week of November 3rd when it traded $5.86. Taking a closer look at the daily chart we can see that before the spike down FOLD had been in an overall upward trend dating back to June 27th when it traded at $5.00. FOLD has a float of 114.20 million shares and traded 1.29 times the normal daily trading volume on Monday. For trading purposes, I would like to see FOLD open trading on Tuesday below $6.85 and if it does I would be looking to take a short position at the bell. My stop loss would be $0.25 from my entry position fearing anything more than that and the stock would start to fill in the gap down.

Company Profile

Amicus Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of medicines for various rare and orphan diseases. Its principal product is the migalastat HCl, a small molecule, which has completed Phase III studies that can be used as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease. The company is also developing SD-101, which is in Phase III clinical study for the treatment of the genetic connective tissue disorder epidermolysis bullosa; ATB200 that is in Phase II studies to treat pompe disease; AT2221, which is in Phase II studies for the treatment of pompe disease; and AT3375 to treat Parkinson's disease. The company has strategic alliance with GlaxoSmithKline plc to develop and commercialize migalastat as a monotherapy and in combination with ERT for Fabry disease. Amicus Therapeutics, Inc. was founded in 2002 and is headquartered in Cranbury, New Jersey.  Yahoo Finance

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