Amicus Therapeutics, Inc. (NASDAQ:FOLD) Down as New Drug Hits Regulatory Hurdle
Northern, WI 06/17/2013 (GDPInsider) – Amicus Therapeutics, Inc. (NASDAQ:FOLD) had a miserable start today and failed to recover from premarket news that it is set to delay the filing for approval for its migalast drug until further late-stage testing is done. The stock opened at 2.31, down 27.58% on its previous close of 3.19 and things didn’t improve much for the rest of the day. Range for the day was 2.30 and 2.63 and volume exploded on a sell-off which saw 3.014 million shares changing hands.
The company has been working on its migalast drug as a treatment for the rare enzyme disorder called Fabry disease. According to the premarket announcement, FOLD had not seen satisfactory results in its main and secondary late-stage testing and that it plans to run an extension to shore up its statistical analysis.
FOLD met with the Food and Drug Administration who decided that the planned extension was not sufficient to support its filing for market approval. The company indicated that it may not have the drug ready for market approval before the second half of 2014. This prompted a mini-panic among investors who started unloading the stock.
Chief Executive Officer John F. Crowley sought to calm investors and said in a conference call that “The FDA has been incredibly helpful and transparent. They clearly recognize the unmet medical need that remains in Fabry disease and are committed to working with us to evaluate the complete data set and to determine a path toward filing an approval.”
The day’s decline marked a new 52-week low for the company which has yet to bring a product to the market. The sell-off also pushed the stock’s RSI deep into oversold territory and now has a value of 25.72. FOLD is also now trading below its SMA50 of 3.21 and insiders account for 41.96% of the transactions in market trading.
Analysts said that it appears the FDA is more comfortable with taking a second look at migalast based on a successful set of clinical trials rather than a new study which doesn’t hold consistency with the goals of the drug.
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