Amicus Therapeutics, Inc. (NASDAQ:FOLD), which is set to announce its 1Q2016 earnings on May 3, recently moved closer to having its lead drug candidate approved for a treatment for a devastating genetic condition in Europe. The company is also expected to seek U.S. approval of the Fabry drug in the U.S. Europe regulators are expected to make their final decision regarding Amicus’ Fabry drug in 2Q2016.
Amicus Therapeutics, Inc. (NASDAQ:FOLD) posted EPS loss of $0.36 in 4Q2015, falling short of the consensus estimate of EPS loss of $0.31. It didn’t generate any revenue in the quarter but approval of its therapy for Fabry diseases could unlock huge revenue opportunity. Amicus will be reporting its 1Q2016 on May 3 at which the management is also expected to highlight the progress of the company’s various drug development programs including the drug for Fabry diseases.
Approval in Europe
A European medical agency recently adopted a positive view regarding the approval of Amicus’ drug for Fabry disease. The drug would be used as an oral treatment for patients afflicted by amenable genetic mutation. If the European agency approves Amicus’ therapy, it would be the first oral treatment for Fabry disease to be cleared for commercialization in Europe.
The European agency will make a final decision about approval of the drug later this year in 2Q 2016.
Seeking FDA approval
The FDA last year raised questions about the side effects of Amicus’ migalastat monotherapy on gastrointestinal. But the company is expected to apply again for U.S. approval of the treatment.
What’s the addressable market?
Fabry disease afflicts between 5,000 and 10,000 people globally, but Amicus Therapeutics, Inc. (NASDAQ:FOLD) believes the number could be higher. The condition can lead to kidney failure, heart disorders and host of other health complications if not arrested in good time. Fabry disease comes as a result of genetic disorder that results into buildup of a specific lipid that has devastating medical consequences.