FOLD caught our attention yesterday as an intriguing pharmaceutical play that recently underwent some panic selling, and is now coming off of the resultant bottom.First a little back-story: Amicus has been teamed up with pharma giant, GlaxoSmithKline (GSK), running clinical trials on a drug called migalastat HCI, meant to treat a rare disease in which a genetic mutation prevents enzymes from breaking down a fatty substance referred to as GL-3. As a result, GL-3 build up in the kidneys can lead to organ failure and death.
The big sell-off occurred back in late December when the duo announced that the study, statistically, failed to meet their objectives after a 6 month period, making a fast-track to FDA approval an impossibility.
The encouraging news, and the reason we think now is a prime time to take a look at FOLD, is that the studies do not conclude at the 6 month point; they have continued, and the 12 month results are expected to come early in 2013. While failing to meet project goals, there was still a 50% reduction in GL-3 buildup in 41% of the migalastat HCI group, as compared to just 28% of the placebo group. The 12-month results will be accompanied by the company meeting FDA officials to discuss the track to approval, and how it is altered by the results of trials still underway.
John F. Crowley, Chairman and Chief Executive Officer, will present a corporate overview at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 9, 2013 at 3:00 p.m. PT. which can be viewed via a LIVE WEBCAST on the specified date and time.
What really jumps out to us, is simply the fact that FOLD recently saw a big gap down, and has now begun to recover. Often in the past we’ve seen cases such as this where the stock bounces back to fill the gap, offering up great opportunities for gain.
It could also come to that sooner, rather than later- The company also has other irons in the fire, as this morning it released a PR regarding another of its drugs currently in testing phases, this time with positive results:
Amicus Therapeutics Announces Positive Results From All Four Cohorts in Phase 2 Chaperone-Enzyme Replacement Therapy (ERT) Co-Administration Study for Pompe Disease
CRANBURY, N.J., Jan 04, 2013 (GLOBE NEWSWIRE via COMTEX) — Strong Proof-of-Concept Data for Chaperone’s Ability to Stabilize and Enhance Activity and Uptake of Currently Marketed ERT Products for Pompe Disease
Results to be Presented at LDN WORLD Symposium in February 2013
Initiation of Repeat-Dose Pompe Study Anticipated in 3Q13
Amicus Therapeutics (Nasdaq: FOLD) today announced positive preliminary results from all 4 dose cohorts in a Phase 2 study (Study 010) to evaluate the safety and pharmacokinetic (PK) effects of the pharmacological chaperone AT2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) for Pompe disease (Myozyme and Lumizyme). Myozyme and Lumizyme (alglucosidase alfa, or recombinant human GAA enzyme, rhGAA) are the first and only approved treatments for Pompe disease.
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We will be continuing to follow this play, and keep everyone updated as more details arise.
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MediSwipe, Inc. MWIP
A lot of you may have missed our last report before the holidays, in which we mentioned that we would like to see MWIP continue to hold support above a penny and test its previous highs. Yesterday saw the stock break past its previous high of .0199 into blue-sky territory, hitting a high of .0289, earning us a spot on the Penny Stock Rumble with a gain of 50%
In total, from the low following our first mention of MWIP back at .0024, yesterday’s high marks an astonishing 1104% gain.
If and when we see a pullback on MWIP, we want to see the previous resistance of .0199 hold as a future level of support for us to remain bullish.
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Extended Watchlist:
UNLA, AHFD, AXCG, SAPX, SFAZ, ZLCS
