What: Ahead of releasing its third-quarter financials tomorrow, shares in Amicus Therapeutics (NASDAQ:FOLD) surged 14.3% higher earlier today.
So what: Shares have fallen sharply since the company announced a delay to its timeline for filing for approval of its Fabry disease therapy, Galafold, in the United States.
Galafold was filed for approval in Europe earlier this year and plans had been for an FDA filing to occur prior to the end of 2015. However, after discussing its plans with regulators, Amicus Therapeutics removed its timing guidance in early October, noting that it's uncertain when it will have the data necessary to complete the application.
The news was disappointing because there's a significant unmet need for additional treatment options for Fabry disease patients and the market for Fabry disease drugs is worth more than $1 billion annually.
Now what: With Amicus Therapeutics slated to report its Q3 results tomorrow after the closing bell, investors are obviously hoping that the company will provide new insight regarding the timing of an FDA application.
I'm not sure that Amicus Therapeutics will be able to offer such clarity tomorrow, but I do think its stock may be an intriguing investment for risk-tolerant investors.
Currently, Fabry disease treatment is dominated by enzyme replacement therapy's that cost roughly $200,000 per year, and that means that if Amicus Therapeutics can secure both EU and U.S. approval, Galafold could have nine-figure revenue potential.
The company estimates that between 30% and 50% of Fabry disease patients possess the genetic makeup that would make them amenable to Galafold and that the global Fabry disease patient population will expand by roughly 10% annually.
Absent Galafold approvals, however, Amicus Therapeutics remains a high-risk, clinical-stage company without any revenue and, therefore, only those able to withstand another setback ought to consider owning it.