Amicus Therapeutics Crashed 54%, But Chardan Is Buying

• Amicus Therapeutics, Inc FOLD shares have plunged 54 percent in the last three months, despite crossing the $18 mark on August 5 and September 14.
• Chardan Capital Markets’ Gbola Amusa upgraded the rating on the company from Neutral to Buy, with a price target of $8.
• Following the significant decline in Amicus Therapeutics’ shares on news of the US regulatory update for its lead product Galafold, the stock reflects extremely pessimistic outcomes for the company, Amusa stated.

Amicus Therapeutics is a pharmaceutical company focused on treatments for the lysosomal storage diseases, or LSDs, Fabry Disease and Pompe Disease, and for an orphan skin disease, epidermolysis bullosa.

Analyst Gbola Amusa said that Amicus Therapeutics’ shares had declined 54 percent after the company announced that it would not be able to submit the US NDA for Galafold monotherapy by 4Q15, as it had previously guided. The announcement comes after follow-up interactions with the FDA, after the September pre-NDA meeting.

Amicus Therapeutics cited several reasons for not being able to submit the US NDA. This included the time required to address the FDA request for the full integration of the safety and efficacy data from Study 011 and Study 012.

The company also cited “ongoing discussions with the FDA for conditional approval for Galafold under Subpart H on endpoints beyond interstitial capillary GL3,” as a reason for the delay.

Another factor that could delay the US regulatory filing was the FDA considering Galafold for full approval instead of conditional approval, Amusa said.

Amusa added, however, that all the reasons cited by Amicus Therapeutics are expected to have only a modest impact on the company’s stock valuation and do not justify the 54 percent decline since the regulatory update. The decline provides a “new opportunity to own FOLD,” the analyst added.