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After 'Yuge' Rally, What Now For Amicus Therapeutics?


  • Amicus Therapeutics continued its recent rally and shot up 25% last week on an unexpected decision reversal from the FDA.
  • The FDA will now accept a NDA on the company's compound galafold without a costly trial, knocking two years off the projected rollout in the U.S.
  • Given how far the shares have come so far in 2017, what is next for this rare disease concern?  We take a look at that below.

Never confuse movement with action.” - Ernest Hemmingway

It was a big week for Amicus Therapeutics (FOLD) and its shareholders. The company was one of the first beneficiaries of a more industry friendly FDA. The governmental agency reversed its ruling last November that tanked the stock. It will no longer require a costly trial for the company to submit a New Drug Application {NDA} for its compound galafold to treat Fabry Disease, a rare affliction. The drug was approved for this indication by European authorities in May of last year and its initial rollout has been gaining momentum recently. The company also just filed a NDA for Japan, where approximately 700 people are afflicted.

Even a secondary offering to raise funding to support the rollout of galafold as well as potentially two other late stage compounds for other rare diseases could do no more than temporarily dampen the enthusiasm for the shares. The stock was up some 25% on the week.

I noted in the November 30th Biotech Forum Daily Digest, where I kept the faith in Amicus, "Hopefully, the FDA is one of many government agencies that get more effective and efficient under the new administration." It is nice to be the recipient of some government efficiency improvements for a change, which can as rare as unicorn sightings.

The stock has soared since that November debacle and had already recovered all of that plunge before this week's good news. For those who initiated or added to their positions back after the original FDA action tanked the stock, congratulations! You are seeing some "yuge" gains.

I have had quite a few questions on what to do with Amicus after this huge rally. First of all, always remember to cull profits using the Jensen Rules or something similar. This means I have

This article was written by

Bret Jensen profile picture
Finding tomorrow's big winners in the lucrative biotech sector

Finding tomorrow's big winners in the lucrative biotech sector, The Biotech Forum focuses on proprietary, breaking research on promising biotech and biopharma stocks with significant potential for outsized alpha. It is the fourth most subscribed to investment service offered through the Marketplace on SeekingAlpha.com. Our service offers a model-20 stock portfolio as well as the most active Live Chat on the Marketplace. This is where scores of seasoned biotech investors trade news and investment ideas back and forth throughout the trading day.

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Specializing in profiling high beta sectors, Bret Jensen founded and also manages The Biotech Forum, The Insiders Forum, and the Busted IPO Forum model portfolios. Finding “gems” in the biotech and small-cap stock sectors, these highly volatile spaces proven hugely successful have empowered Bret Jensen's own investing portfolio.

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Analyst’s Disclosure: I am/we are long FOLD, GILD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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