Upcoming PDUFA Dates for Sub-$5 Stocks

by: Alex Shadunsky

There are six PDUFA dates on the calendar between now and early next year for sub-$5 stocks trading on one of the three main exchanges. The reason for the focus on sub-$5 stocks is because their prices seem to exhibit the most gains into their respective PDUFA dates, thereby giving the opportunity to buy the stock some months ahead of the PDUFA date, take part in the run-up, and sell shortly before the PDUFA date.

Adventrx (ANX) has a PDUFA date on Sept. 1 for Exelbine (ANX-530) for non-small-cell lung cancer. ANX-530 is the company’s proprietary emulsion formulation of vinorelbine, which is a vesicant and venous irritant; these adverse effects can limit its tolerability. ANX-530 was designed to be bioequivalent to the reference drug while reducing the incidence and severity of vein irritation associated with intravenous delivery of the drug. In a clinical bioequivalence study, ANX 530 and the reference drug were determined to be bioequivalent. The stock was last trading at $3.00.

pSivida (NASDAQ:PSDV) has a PDUFA date on Nov. 12 for Iluvien for the treatment of diabetic macular edema (DME), the primary cause of vision loss associated with diabetic retinopathy, a disease affecting the macula (the part of the retina responsible for central vision). Iluvien is an investigational, extended release intravitreal insert for the treatment of DME. Each Iluvien insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FAc. Iluvien is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound. The stock was last trading at $4.30.

BioSante Pharmaceuticals (BPAX) has a PDUFA date on Nov. 14 for the Bio-T-Gel NDA. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva (NYSE:TEVA) for late-stage clinical development. Teva is responsible for all Bio-T-Gel's regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion. The stock was last trading at $2.91.

Antares Pharma (AIS) has a PDUFA date on Dec. 8 for Anturol Gel in patients with overactive bladder (OAB). Anturol is an oxybutynin gel based on the ATD Gel technology platform, which is a clear, odorless hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. The ATD technology is also used in Elestrin, an FDA-approved product for hormone replacement therapy in postmenopausal women. It has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. By delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. These side effects are believed to account for a significant level of patient non-compliance among existing oral OAB treatments. The stock was last trading at $2.32.

Corcept Therapeutics (NASDAQ:CORT) has a PDUFA date on Feb. 17, 2012 for Corlux for Cushing's Syndrome. Corcept's first-generation compound, Corlux, also known as mifepristone, directly blocks the cortisol (GR-II) receptor and the progesterone receptor. Intellectual property protection is in place to protect important methods of use for Corlux. Corcept retains worldwide rights to its intellectual property related to Corlux. The stock was last trading at $3.91.

Columbia Laboratories (CBRX) has a PDUFA date on Feb. 26, 2012 for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. Crinone (progesterone gel) was approved by the FDA in May 1997 for progesterone supplementation or replacement as part of an Assisted Reproductive Technology treatment for infertile women with a progesterone deficiency. Patient preference for Crinone over competing products has been demonstrated in five clinical trials. The product is also available under the trade name Prochieve and available in both 4% and 8% concentrations. Crinone/Prochieve 4% is indicated for the treatment of secondary amenorrhea. The stock was last trading at $3.14.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.