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Amicus Therapeutics, Inc. (FOLD)

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13.53-0.08 (-0.59%)
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  • I have one question for the irrational here!

    Why would you issue stock here (13 bucks) right before you get great news (and the stock goes super high) on the phase 3 data for EB????

    Crowley is wicked smart...or just plain wicked...
  • KTOV = Mcap $16 Mil /Cash $17 Mil / ULTRA Low float / NDA submission for potential Blockbuster this Quarter = 20 BAGGER ..ONE OF THE BIGGEST BIOTECH OPPORTUNITY EVER ! Thank me later guys

    Kitov Pharma (KTOV)

    Market Cap: $17 M
    Cash $17 M
    Price: $1.50

    Shares Out: 10.6 Million

    Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension

    Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.

    KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously

    Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial

    Marketing potential Pipeline candidates address large, multi-billion dollar markets


    Kitov’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.


    Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.

  • Longs, Beware the prescient posts of moe. He has been so spot on since his bashing of FOLD at 6 bucks that when he says our CEO is a #$%$, he must have information that points to that. He says that Mr. Crowley lied about the FDA requiring a new trial for Migalistat as the FDA NEVER does stuff like that. CEOs of BMY, LLY, MRK ect have all had that happen to them but what would they know about the FDA? Hell just because they run billion dollar companies doesn't mean that they too aren't liars when the FDA coldcocks them out of nowhere. moeRon also won't post his position here so we must suspect that his bashing of FOLD, which began at 5 dollars or so, is his original short price. He will say it doesn't matter if one makes money and that I focus on it too much. His arguement is nothing but liberal spew that is intended to distract from the fact that he is getting killed here. It's s easy for people like moeRon to bash behind her keyboard. What a pfaggot.
  • mathew is a compulsive liar and and the vice president of the imbecile section of the moron club. He hates FOLD because he worked as a janitor at their HQ and he got caught backhanding himself to kiddie porn so they fired him. hahahahaaha
  • Hey mathew whats it like to be down 120%? Think how much you would have if only you listened to me. hahahahahahahaha
  • Day after secondary announcement the stock craters ( 7/13) & in the following 5 days quickly recovers & rises 14% ...wow!.... secondary offerings are usually more toxic...huge sign of strength ...stay long my friends...this is the real deal.
  • 12.50 or gap needs filled at 11.50? Typical chat move for these spikes.
  • You better cover. Back under 13.
  • So you get great news and offer up a stock offering. Seems pretty smart in that you would have expected a rebound since the money was geared to bring the drug to market. Maybe I'm wrong but why not do that while stock is high and protect the funds needed. I can only hope that confidence level is one combing from a great comfort in the success of this drug.
  • This is one of the best price actions I've seen after the offering. Company raised $250m and price recovered basically to the 7/12 point
  • Harry Boxer has posted his Tuesday’s Charts of the Day video on FOLD at TheTechTrader site noting: Swing trade Amicus Therapeutics, Inc. (FOLD) is acting great, popping another 90 cents, or 7%, to 13.81, on 7.85 million shares traded. That’s heavy volume for this stock. It popped, consolidated, and exploded, pulled back, held the gap, ran up and pulled back again, and then ran up again on Tuesday. I’m looking for 15 and 18 as targets going forward.
  • I think Amicus raised money in anticipation of the results from Zorblisa Phase 3 study which will be released any time this quarter. If the results are positive, Amicus will need to pay substantial clinical and regulatory milestones to Scioderm shareholders. Here is quote from Scioderm acquisition PR:
    "Amicus has agreed to pay up to an additional $361 million to Scioderm shareholders, option holders and warrant holders upon achievement of certain clinical and regulatory milestones."
  • Harry Boxer has posted his Charts of the Day video on FOLD at TheTechTrader site noting: Amicus Therapeutics, Inc. (FOLD) popped out of the wedge and pulled back, and was up just 7 cents to 12.91, on 8 million shares traded. I wanted you to see this pattern as it portends more upside to 15 and 18.
  • We should all be wise to remember that this company is burning through cash at a rate of 50+ million PER quarter and will make less than 50 million in revenue this year.
  • Posted in $ARWR conversation
    Interesting development...
    Amicus Therapeutics $FOLD announced early Tuesday that the FDA has dropped its demand for a new Phase III study of its Fabry disease drug migalastat after it was stiff-armed by unsatisfied regulators last fall — then under a different administration with a different FDA commissioner.

    Instead of pursuing a new and expensive late-stage study, Amicus CEO John Crowley tells me the company has the green light to file again with the data at hand. And based on discussions with the FDA, he adds, the company is shooting to file in the 4th quarter, with an accelerated approval that could arrive in 2018, potentially slicing years off the process.

    “These are the days it’s good to be a biotech CEO,” says Crowley, who has been on a roller coaster ride at the FDA over the past year after being forced to walk back his own plans last November.

    John Crowley
    There is no guarantee of an approval here, but the agency’s sudden volte-face clearly signals a new tone that vastly improves the biotech’s shot at an OK — at least in so far as we hear it from Crowley. And that could have a major influence on other developers tackling the same task.

    Investors cheered on the sudden change in fortunes at Amicus, bidding up shares by 43% in pre-market trading Tuesday.

    Crowley has never made a secret of the fact that he felt the drug — approved in Europe last year — was ready to go in the US after it completed the pivotal program. The FDA, though, rejected his application, saying regulators wanted more safety data than the Europeans needed.

    That rejection became a cause celebre of sorts in DC, as President Donald Trump turned to Crowley’s daughter, Megan, who suffers from Pompe disease, and called out the FDA for the “slow and burdensome” process involved in new drug approvals during an address to Congress.

    “Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need,” Trump said at the time. “If we slash the restraints, not just at the FDA, but across our government, then we will be blessed with far more miracles like Megan.”

    Crowley picked up on that change in thinking at the White House in a blog post at the time in which he said: “The FDA’s regulation of the orphan development process is becoming less flexible, less efficient and less patient-centered.”
  • ACRX Volume today 26x the daily average volume... 2 back-to-back Buy Recommendations... 400% upside potential... ACRX's DSUVIA FDA PDUFA date is October 12, 2017... Heads up biotech followers...
  • Why would FOLD need to raise cash? They have pleny
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  • It's a smart move. With this offering Fold should last 2 years and by that point we should be cash flow positive. Buy on dip tomorrow
  • Not sure how the market will digest this, but you should consider US approval a slam dunk. No way the current FDA is going to push Migalistat out another 2-3 years while patients all over the world are enjoying documented benefits from this drug. With the bulk of the adoption in EU so far from patients switching from current ERT, it is clear the drug is safe and effective and there is nothing in the data that would put that conclusion in doubt.