Six Stocks That Could Get An October Bump From The FDA

With the stock market struggling to make headway, investors might look for event-driven trades to find equities with pending news that could lead to a price pop. One of the biggest movers of stock prices is an FDA OK. Of course, a thumbs down from the regulatory agency typically leads to a crushing.

iStock has identified four drugs/products that are up for approval in October. If any of them get the OK, shares of the underlying companies could possibly rock.

On October 3rd, next Thursday, Pfizer Inc. (PFE) and Ligand Pharmaceuticals Incorporated (LGND) expect to hear from the FDA on bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 14, 2013 for Antares Pharma Inc.'s (ATRS) OTREXUP, which is a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet™ technology, has been accepted by the U.S Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. OTREXUP is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

On October 17th, pSivida Corp. (PSDV) and Alimera Sciences, Inc. (ALIM) will be waiting anxiously for word from the FDA on the resubmission of the NDA and the new PDUFA for ILUVIEN. ILUVIEN (190 micrograms fluocinolone acetonide intravitreal implant in applicator) is a sustained release intravitreal micro-insert used to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies. Each ILUVIEN implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels o! f fluocinolone acetonide (FAc). ILUVIEN is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics.

Finally, October 21st will be FDA-day for AMAG Pharmaceuticals, Inc.'s (AMAG) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use. The company's supplemental new drug application (sNDA) for Feraheme requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to adult patients with IDA who have failed or could not take oral iron treatment.

Investors with the stomach for high risk for potential substantial returns might consider adding the aforementioned names to their Google calendars. If any or all of them hit the FDA jackpot, so could shareholders.