Ampio Pharmaceuticals (AMPE) Stock | FDA Grants SPA


Ampio Pharmaceuticals, Inc.  (NYSE: AMPE)


Ampio Pharmaceuticals, Inc. (AMPE), a biopharmaceutical company, announced yesterday that they received a Special Protocol Assessment (SPA) from the FDA and can now begin their second Phase III study of their drug Ampion. Ampion treats pain and inflammation for osteoarthritis of the knee.


Ampio Pharmaceuticals, Inc. CEO’s Comments

Michael Macaluso, Ampio’s CEO, noted,

 “We have been awarded multiple patents to protect the formulation of Ampion™. But more importantly, the FDA has required Ampion™ to meet the clinical obligations for a novel biologic, a special designation that comes with 12 years of market exclusivity. Finally, this second pivotal trial is clinically identical to the previously successful Spring Study, which was confirmed by the agency as one of the two pivotal trials required for approval. In our recent communication with the agency confirming the SPA, the FDA wrote: protocol AP-003-B is adequate to serve as a pivotal trial in support of a future BLA.  With positive results and an SPA, Ampion™ has a clearly defined path to market.”  PR Newswire


AMPE Technical Analysis


AMPE gapped up in price yesterday to $3.80, up from the prior day’s close of $3.18, which is a 19% increase in price based on favorable news.  Taking a look at the daily chart, we can see the last time the stock traded above this price level was back on April 17, when it closed at $7.87. As we can see, that is almost double the price of the current level, and on that occasion the stock tanked all the way to $2.69 on the next day of trading equivalent to a 66% drop in price.  The drop was due to their drug Ampion not reaching its primary endpoint in a drug study. Since that drop, the stock has been in a range between $2 and $3 until this recent spike up. The stock did make this move on heavy volume, as it is trading at 7 times the normal daily trading volume. The stock did reach pre market highs of $4.13 meaning that it gave back $0.33 at the open equivalent to an 8% drop in price. For trading purposes my entry point would have been $3.90 looking for a run thru $4.00. My stop loss would have been $3.70 fearing anything below that and the stock will start to fill in the gap up.


Company Profile

Ampio Pharmaceuticals, Inc., a biopharmaceutical company, focuses on developing therapies for the treatment of prevalent inflammatory conditions in the United States. The company is developing compounds that decrease inflammation by inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and decreasing vascular permeability. Its lead product candidates in development include Ampion, which is in Phase III clinical trial for osteoarthritis of the knee; and Optina that is in Phase IIb clinical trial for diabetic macular edema. Ampio Pharmaceuticals, Inc. is headquartered in Englewood, Colorado.  Yahoo Finance