APPA continues to fly!
A.P. Pharma, Inc. (OTC: APPA) made an explosive move up in recent months from the $0.50 range to recent highs of $0.90 per share. Since then the stock dropped significantly after the FDA requested more information from APPA on March 28.
The excitement on AAPA comes from the Company's lead product; APF530, a long-acting formulation of the anti-emetic granisetron for the treatment of acute and delayed onset chemotherapy-induced nausea and vomiting (CINV.) The product is currently under review by the FDA with an approval decision expected on or before March 27.
According to available market data APF530 has a total market opportunity of around $900 million in the US alone where 5.1 million vials of injectable 5-HT3 were administered in 2011 at an average price of $1.75 Another factor catching investors eye on APPA is the large blocks of stock owned by hedge funds and accredited investors such as Baker Brothers, Tang Capital Management and Perceptive Advisors.
A.P. Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer(TM) polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be injected only once every one or two weeks.
The Company's lead product is APF530, it is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting. A.P. Pharma resubmitted its New Drug Application (NDA) for APF530 to the U.S. Food and Drug Administration in September 2012 and has been assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2013.
Conclusion: Currently trading at a market valuation of $200 million plus, APPA trades at a fairly high market valuation considering they do not yet have FDA approval. However, the stock has momentum, volume and positive investors sentiment on its side which could drive it much higher short term. Expect to see a drop off once the FDA excitements abides.
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