AP Pharma Inc. (OTC: APPA) Stock on Fire!
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.
– With respect to chemistry, manufacturing and controls (CMC), the FDA has requested the refinement of one product quality analytical test method, and that certain deficiencies identified during facility pre-approval inspections be addressed.
– The FDA has requested that a human factors validation study evaluating the usability of the APF530 syringe system together with its proposed product labeling and instructions for use be conducted with product assembled using a validated, commercial process.
– With respect to clinical, the FDA has requested a re-analysis of the existing Phase 3 clinical data that reclassifies patients into those receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) according to the recently modified ASCO 2011 Guideline. The FDA did not request any new clinical studies.
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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A.P. Pharma, Inc.
SYMBOL: OTC: APPA
Shares Outstanding: 302,205,555
Market Cap: $221,818,877
A.P. Pharma, Inc. (OTC: APPA) 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 candidate, APF530, is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV, so this indication represents an area of particular unmet medical need. APF530 contains the 5-HT3 antagonist granisetron formulated in the Company’s proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. This five-day range is designed to cover the delayed phase of CINV, whereas currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for APF530 because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
Formerly=Advanced Polymer Systems, Inc. until 5-01
Delisted from NASDAQ on 04/01/11
Capital Change=shs decreased by 1 for 4 split. Pay date=05/25/2007