Aeterna Zentaris Inc. (AEZS)
On December 28th Aeterna Zentaris announced that it has reached an agreement with the U.S. Food and Drug Administration (“FDA”) on a Special Protocol Assessment (“SPA”) for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108. Optimistic market reaction on this announcement boosted AEZS shares price to the high of $2.70/share on 10fold of its 3month average volume.
Non-experienced biotech investors frequently interpret the SPA agreement as an explicit drug approval event. FDA explanation of SPA is:
However, final determinations are made after a complete review of a marketing application and are based on the entire data in the application.
Evermore, over two-third of the biotech’ (at least for the last 5 years) that previously had signed SPA agreements for their Phase 3 drugs, had never been approved. We took a short position on AEZS stock based on the following reasons:
- AEZS-108 mixed results
- Aetherna’s history of stock dilution
- Undermining Phase 3 time-frame
Our short sell cover target sets to below $2/share.
Cellceutix Corporation (CTIX)
Short position on CTIX (see our report from December 25th) has been covered at and between $1.60/$1.70/share from short sell at $2.40/share. 45% gain: done deal.
Some of our “A list” subscribers enjoyed even more in profits.
Amicus Therapeutics Inc (FOLD)
Amicus Therapeutics lost over half of its market value since December 20th after the company announced that Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay results have been failed.
We think that FOLD stock found a bottom and ready to bounce back up on the following reasons:
- The U.S. Food and Drug Administration agreed to consider the 12-month efficacy and safety data oral migalastat HCl monotherapy versus failed 6-month data
- These 12-month data results expected to be available in the first half of 2013
- More from pipeline: Amicus’s Phase II Trial of AT2220 drug in the treatment of Pompe Disease that has been well-tolerated and demonstrated no related adverse events
- More from pipeline: Amicus’s preclinical AT2101 and AT3375 drug studies for the treatment of Gaucher Disease and the Gaucher-Parkinson’s Link
- Amicus is a “cash-rich” company with $100M cash/hands versus almost no debt
- FOLD stock is heavily shorted (18 percent of float is shorted) and short squeeze to be expected on any positive company’s updates
Amicus Therapeutics, Inc.
1 Cedar Brook Drive
Cranbury, NJ 08512
Amicus Therapeutics is a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases. The Company has a robust pipeline of novel, first-in-class, small molecules called pharmacological chaperones for the treatment of lysosomal storage diseases (LSDs).
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