A late day price and volume spike placed shares of Ampio Pharmaceuticals (AMPE) more than ten percent higher than where they opened on Wednesday, a notable feat on a day dominated by bleeding red in the markets as the DOW, Nasdaq and S&P were all down by over a percentage point. No news accompanied AMPE's impressive trading action, but speculation would have it that something may be cooking in terms of pipeline news, given the already solid progress demonstrated by the company's pipeline over the past few quarters.
Last week AMPE was highlighted as a stock positioned for a rebound.
Three products are currently chugging through development, all targeting highly lucrative markets, and success in early trials has Ampio now negotiating with the FDA on a design to conduct definitive studies in the United States that could lead to product approvals.
Of the three main pipeline products, Zertane is the most advanced, having passed Phase III trials in the treatment of premature ejaculation (PE) and become the subject of multiple regional partnership deals overseas. Although the US FDA does not recognize PE as a medical need, Ampio has initiated talks with the agency in order to bring the product to market in the US.
Ampion, the company's lead product candidate, is being positioned to potentially become a key player in the very lucrative anti-inflammatory market. If Ampion can break into even a fragment of that market, and its likely that it could based on early trial results and considering the established side effects of current anti-inflammatories, such as Tylenol and Ibuprofen, then the product has a good chance at achieving blockbuster status. Results have been encouraging thus far in development - with both safety and efficacy - and a round of definitive trials could commence later this year in the US. Discussions with the FDA relating to these trials are ongoing.
Another product, Optina, is being developed as an oral treatment for diabetic macular edema and diabetic retinopathy, offering the company another large market to target. Developmental results have been positive to date and the product completes a solid trio of potential large-market product candidates for Ampio, conveniently at a time when large pharmaceutical companies, such as Pfizer (PFE) are taking measures to boost pipelines that have been depleted by key patent expirations.
Ampio's recent pipeline progress consistently places this company on stock watch lists for its inherent catalyst potential. Since the company's products are repositioned, meaning that they have already been approved to treat different indications, the path to approval should be a lot quicker than that of entirely new drugs, mainly because safety has already been clincally and commercially established.
That is a huge benefit for a small company such as Ampio and a key factor for investors taking a look at a possible investment.
Shares were spiking close to fifteen percent during the last hour of trading on Wednesday, making AMPE a hot stock to watch right now, especially given its performance on a day that Spanish banking fears spread panic through the global markets.
Disclosure: Long AMPE.
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