Below are seven companies from the
BioMedReports.com FDA Calendar database of over 200 entries, which have pending new drug decision(s) at the FDA combined with a stock price that is below its 200-day moving average (200-DMA). The list includes a balanced mix of two large-caps, two mid-caps, and three small-cap stocks which have been laggards in the overall market rally with looming regulatory catalysts in the form of FDA new drug decisions serving as potential upside catalysts. Data Source: Yahoo! Finance on 6/17/09 during late day trading.
1.) Abbott Labs (NYSE:ABT): Price $46.00, 200-DMA $48.53
On 6/4/09, ABT and AstraZeneca (NYSE:AZN) announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two or more lipid abnormalities including high LDL (bad) cholesterol, high triglycerides and low HDL (good) cholesterol. The NDA submission for this investigational compound, containing the active ingredients of CRESTOR (rosuvastatin) and TRILIPIX (fenofibric acid), is supported by data from multiple studies, including efficacy and safety studies with the 5mg, 10mg and 20mg doses of rosuvastatin combined with fenofibric acid. Pending approval of the NDA, the treatment will be marketed as CERTRIAD. The estimated PDUFA decision date is 4/4/10 for a standard, 10-month review by the FDA.
2.) Eli Lilly (NYSE:LLY): Price $33.46, 200-DMA $34.63
On 6/3/09, LLY announced that it resubmitted its supplemental New Drug Application (sNDA) for Cymbalta (duloxetine HCl) for the management of chronic pain to the FDA. Lilly's resubmission is based on a recently completed study in chronic pain due to osteoarthritis, the extension phase of a chronic low back pain study and previously completed studies in pain due to osteoarthritis and chronic low back pain. The application is supported by studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Lilly originally submitted the sNDA in the second quarter of 2008 but withdrew the application in November 2008 following discussions with the FDA primarily about statistical methodology and study design.
LLY is also awaiting an overdue decision for its pending EFIENT (prasugrel) NDA - acute coronary syndrome (ACS) - 2/3/09 unanimous FDA panel recommendation for approval - 2/23/09 announcement of approval in Europe for the prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (PCI).
