Amicus Therapeutics (FOLD) Spikes on Phase III Data for Fabry Disease Treatment

Joel Anderson  |

Shares in Amicus Therapeutics (FOLD) spiked on Tuesday following the news that its lead therapy, climbing over 20 percent after reporting success in Phase III trials of migalastat HCL in treating Fabry Disease.

The news, released prior to the opening bell, was solidly positive. Fabry Disease is a genetic disorder that affects fat storage and results in globotriaosylceramide (known as Gb3 or GL-3) to accumulate in blood vessels and other tissues and organs, negatively affecting their proper function. Migalastat HCL treats the disease by altering a patients cell function to address the gene mutation causing the disorder and degrade the GL-3.

The Phase III trial was testing migalastat HCL as a monotherapy and showed positive 12- and 24-month data for treating patients with Fabry. While the 6-month results weren’t significantly significant, the data improved for patients taking the treatment after 12 months, with migalastat HCL being generally safe and well tolerated and showing significant reductions in the disease substrate and GL-3.

The success was big news for small-cap Amicus, which focuses its efforts on treatments for rare and/or orphan diseases, which had been struggling of late, with stock down over 30 percent over the last year and almost 75 percent over the last five years.

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“Today is a great day for Amicus and the Fabry community,” said Chairman and CEO John F. Crowley. “We are pleased to report that the 12 and 24 month results from Study 011 have met our pre-defined criteria for success in terms of substrate reduction at 12 months, as well as clinical measures of kidney function maintained out to 24 months. We believe these data provide important validation that a small-molecule chaperone can restore the function of a patient's own enzyme in patients with amenable mutations, and that our pharmacogenomic assays can identify these patients.”

The stock opened up 26.6 percent at $2.33 a share after gaining as much as 47 percent in after-hours trading. Shares quickly climbed to an intraday high of $2.50 apiece before pulling back and settling in at just under $2.25 a share, very close to the stock’s 50-day SMA.

The stock, though, may have been veering into oversold territory of late based on some key technical factors. After hitting its highest level since mid-June at just under $3.10 a share in mid-January in a spike that followed the release of FY-2014 guidance, the stock has been declining rapidly, falling over 40 percent from its peak to yesterday.

However, the stock was started to show signs of recovery earlier in April. Notably, the stock delved well into oversold territory on April 15 when shares hit a 52-week low of $1.76 apiece just after the stock’s MACD line crossed the signal line from above. At that point, though, the stock dipped  below its lower Bollinger Band, below 0.20 in its 14-day stochastic RSI, and touched a 14-day RSI of 30.0 on April 16.

The stock had also formed a descending triangle pattern with a downward sloping resistance line and a support level of $2 a share. The stock appeared to begin a downward breakout when it dipped below $2 a share on April 15, but the new clinical data ultimately rendered all of these technical factors insignificant, as shares crashed past resistance and crossed the 200-day SMA from below.

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