Amicus Therapeutics (FOLD) Stock Spikes Today Following Accelerated Approval Filing Plan
NEW YORK (TheStreet) -- Amicus Therapeutics (FOLD) - Get Report shares are rising, up 27.85% to $11.95, in trading on Thursday after the biopharmaceutical company announced that it will seek accelerated U.S. approval for its Fabry disease therapy, migalastat, following a productive meeting with the FDA.
The company expects to submit its application for approval in the second half of this year, ahead of the expectations of many analysts', according to TheStreet's Adam Feuerstein. Amicus will also seek European regulatory approval for the drug in the second quarter this year, also ahead of expectations.
If approved, migalastat will be the first oral therapy for Fabry disease, a rare, inherited genetic mutation that stops bodily enzymes from breaking down a fatty substance known as globotriaosylceramide, or GL3, a buildup of which could cause severe damage to kidneys, heart, brain and other organ systems. Fabry disease affects about 10,000 people worldwide.
TheStreet has further coverage of Amicus' plans for migalastat here.
TheStreet Ratings team rates AMICUS THERAPEUTICS INC as a Sell with a ratings score of D-. TheStreet Ratings Team has this to say about their recommendation:
"We rate AMICUS THERAPEUTICS INC (FOLD) a SELL. This is driven by a number of negative factors, which we believe should have a greater impact than any strengths, and could make it more difficult for investors to achieve positive results compared to most of the stocks we cover. The company's weaknesses can be seen in multiple areas, such as its deteriorating net income and weak operating cash flow."
Highlights from the analysis by TheStreet Ratings Team goes as follows:
- The company, on the basis of change in net income from the same quarter one year ago, has significantly underperformed when compared to that of the S&P 500 and the Biotechnology industry. The net income has decreased by 17.5% when compared to the same quarter one year ago, dropping from -$14.59 million to -$17.15 million.
- Net operating cash flow has decreased to -$15.12 million or 11.90% when compared to the same quarter last year. In addition, when comparing to the industry average, the firm's growth rate is much lower.
- The company's current return on equity greatly increased when compared to its ROE from the same quarter one year prior. This is a signal of significant strength within the corporation. Compared to other companies in the Biotechnology industry and the overall market, AMICUS THERAPEUTICS INC's return on equity significantly trails that of both the industry average and the S&P 500.
- AMICUS THERAPEUTICS INC has improved earnings per share by 24.1% in the most recent quarter compared to the same quarter a year ago. This company has reported somewhat volatile earnings recently. But, we feel it is poised for EPS growth in the coming year. During the past fiscal year, AMICUS THERAPEUTICS INC reported poor results of -$1.17 versus -$1.09 in the prior year. This year, the market expects an improvement in earnings (-$0.89 versus -$1.17).
- Investors have driven up the company's shares by 314.86% over the past year, a rise that has exceeded that of the S&P 500 Index. Regarding the future course of this stock, we feel that the risks involved in investing in FOLD do not compensate for any future upside potential, despite the fact that it has seen nice gains over the past 12 months.
- You can view the full analysis from the report here: FOLD Ratings Report
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