AMAG Pharma (AMAG) more than doubled on word that the FDA accepted its complete response for a NDA of iron-deficiency anemia drug ferumoxytol in patients with chronic kidney disease and will issue a final ruling before year-end. The news is a major relief for AMAG as no new clinical trials were required and the quick decision deadline before year-end is encouraging for the approval prospects of ferumoxytol.
A trio of companies expect FDA decisions for abuse-resistant pain drugs before year-end, including Pain Therapeutics (PTIE) + King Pharma (KG) for Remoxy and Alpharma (ALO) for Embeda. Now that Alpharma has accepted King's buyout bid, the latter reflects a way to trade both decisions in a single stock for twice the chances of approval.
Caraco Pharma (CPD) offers U.S. investors a way to play India-based Sun Pharma's growth through their distribution agreement and the Company believes it has addressed the issues raised in the FDA warning letter completely, which provides a potential upside catalyst upon resolution. Caraco has lost an astounding two-thirds of its market value in just the past month and over three-quarters of value in the past year despite the fact the Company has enough cash on hand ($33.6M) to buy back almost its entire float of 11.3M outstanding shares at current prices.
Cypress Bioscience (CYPB) is still waiting for a FDA decision for milnacipran in the treatment of fibromyalgia, which has been widely used as an anti-depressant in Europe and other markets for over a decade. The FDA missed its mid-October decision deadline, but said it expected to resolve the matter in a "matter of weeks", which is encouraging since the agency did not simply delay the deadline by three months as it has done in many recent cases. Another key event is Phase 3 results for the drug for the same indication, with results expected before year-end.
A FDA decision is also possible before year-end for Johnson & Johnson (JNJ) and Medarex (MEDX) for a biological agent, Stelara (ustekinumab), in the treatment of psoriasis – with a FDA panel endorsement this past June and clinical trial results in September which showed it was more effective than Amgen's (AMGN) Enbrel in a short-term, 12-week study of patients with moderate to severe plaque psoriasis.
Material Stock Opportunities? Freeport McMoRan (FCX) is tanking today after suspending its dividend and cutting copper production in the face of waning demand and low prices. However, with FCX trading with a 17-handle today compared to triple digit highs this past summer, the stock is one to watch for a buy on the prospects for a rebound in housing and the overall economy. Along with FCX, other beaten-up basic materials companies include Alcoa (AA), Barrick Gold (ABX), Silver Wheaton (SLW), and Potash (POT).
