Why Amicus Therapeutics, Inc. (FOLD) Stock Is Skyrocketing Today

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Amicus Therapeutics, Inc. (NASDAQ:FOLD) stock is surging following a meeting with U.S. and Europe regulators.

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The meeting between Amicus Therapeutics and regulators was to talk about approval for the company’s medicine for Fabry patients. The drugs would be taken orally and target amenable genetic mutations. It is called migalastat monotherapy.

Amicus Therapeutics’ meeting with European regulators was positive. The regulators agreed to allow the company to submit a marketing authorization application for its drug. They also showed support for the company to request Accelerated Assessment for migalastat monotherapy.

Amicus Therapeutics’ meeting with U.S. Food and Drug Administration (FDA) was also positive. The company will also be seeking accelerated approval for migalastat monotherapy in the U.S. The company needs to complete a Phase 4 study to submit its approval and plans to be able to do so in the second half of 2015.

FOLD shares were up 30% as of Noon Thursday.

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