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Amicus Therapeutics Plunges on Delay in NDA Submission

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Shares of Amicus TherapeuticsFOLD plunged significantly after the FDA asked for additional data on its lead candidate, galafold (migalastat).

The candidate is being evaluated for the treatment of Fabry disease. Amicus announced that it has received minutes from its pre New Drug Application (NDA) meeting with the FDA held in Sep 2015. Thereafter, the company has been conducting additional follow-up interactions with the FDA.

Amicus has been asked by the FDA to produce additional data on galafold's effect on gastrointestinal symptoms in Fabry disease to support its NDA submission requesting full approval as well as a Subpart H strategy.

The FDA has also asked for further integration of existing clinical data across studies. This will require more time to complete, causing a delay in NDA submission, Amicus is not likely to submit the NDA for galafold in the U.S. by the end of 2015.

Our Take

The delay in submission of the NDA was quite disappointing as galafold is Amicus' lead candidate. The NDA submission and a potential approval thereafter would have boosted the company's growth prospects. We note that the candidate is in review in the EU.

Amicus does not have any approved product in its kitty at the moment.

Meanwhile, the company is also developing next-generation enzyme replacement therapy products for Fabry disease, Pompe disease and mucopolysaccharidosis type 1.

We note that the prescribed treatments for Fabry disease include Sanofi's SNY Fabrazyme and Shire's SHPG Replagal among others.

Amicus currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Abbott Laboratories ABT , with a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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