This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

10 Biotech Stocks Facing FDA Judgment Day

Drug approval decisions by the Food and Drug Administration can be important stock-moving events. But putting together a calendar of these potential catalysts can be difficult.

The FDA's Web site isn't very helpful, and unless you have access to scores of sell-side research reports, you're pretty much on your own. It's no wonder I get a lot of email from readers asking for biotech event calendars.

Here's some help. I've put together a list of key upcoming FDA drug approval decisions for the rest of the year. This isn't comprehensive, but it does cover most, if not all, new drugs being developed by biotech firms. There are a few specialty pharma and Big Pharma drugs on the list, too.

Here are some of the more notable pending FDA decisions:

Cephalon (CEPH)
Drug/indication: Nuvigil for improved wakefulness
FDA decision date: June 16 (a report of the decision may come Monday)

Nuvigil is an important second-generation version of Cephalon's wake-promoting drug Provigil, which will soon go generic. With a longer half-life, Nuvigil is expected to remain effective longer, upwards of 10 to 11 hours vs. 6 to 7 hours for Provigil. Originally approved as a treatment for narcolepsy, Provigil (and soon Nuvigil) are used more commonly to combat shift-work fatigue, excessive daytime sleepiness and for people with sleep apnea.

Neurochem (NRMX)
Drug/indication: Kiacta for amyloidosis
FDA decision date: July 16

An approval decision on Kiacta has been delayed since August 2006, when the FDA asked Neurochem for more efficacy data and indicated that the company should run another clinical trial. Neurochen chose not to do that, opting instead to give the FDA additional data from its existing clinical trial. Needless to say, Kiacta's approval -- yes or no -- is a controversial question.

Do you think it's safe to invest in biotechs ahead of FDA decisions?
Answer Here

DOR BioPharma (DORB)
Drug/indication: OrBec for graft vs. host disease
FDA decision date: July 21

When a May 9 FDA advisory panel voted to recommend against approval of OrBec, the drug's prospects took a significant turn for the worse. While the FDA doesn't always follow the advice of its panel, it's not likely to go the other way in this case.

Judgment Day
Expected FDA Decision Date Company Drug Indication
6/15/2007 Encysive Pharmaceuticals Thelin Pulmonary Arterial Hypertension (PAH)
6/16/2007 Cephalon Nuvigil Narcolepsy
6/16/2007 Cephalon Nuvigil Sleep Apnea
6/18/2007 Gilead Sciences Letairis Pulmonary Arterial Hypertension (PAH)
Now-06/30/2007 Pfizer Celsentri HIV/AIDS
7/16/2007 Neurochem Kiacta Amyloid A Amyloidosis
7/21/2007 DOR BioPharma OrBec Graft vs. Host Disease (GVHD)
7/26/2007 Sanofi-Aventis Zimulti Obesity
7/29/2007 KV Pharmaceutical Evamist Menopause
8/1/2007 POZEN Trexima Migraine Headaches
8/13/2007 Indevus Pharmaceuticals Sanctura XR Overactive Bladder
8/15/2007 GPC Biotech Satraplatin Prostate Cancer
8/26/2007 IDM Pharma Junovan Bone Cancer
8/30/2007 Tercica Somatuline Autogel Acromegaly
9/6/2007 Omrix Pharmaceuticals Thrombin Hemostasis
10/7/2007 Theravance Telavancin Skin and Skin-Structure Infections
10/15/2007 Elan/Biogen Idec Tysabri Crohn's Disease
10/18/2007 ZymoGenetics rThrombin Hemostasis
10/18/2007 Cardiome Pharma Vernakalant hydrochloride (iv) Dysrhythmia (Arrhythmia)
10/20/2007 Pfizer Lyrica Fibromyalgia
10/21/2007 Genzyme Renvela End-Stage Renal Disease (ESRD)
11/1/2007 Forest Laboratories Nebivolol Hypertension (Systemic)
11/18/2007 Basilea Pharmaceutica Ceftobiprole Skin and Skin-Structure Infections
11/24/2007 BioMarin Pharmaceutical Kuvan Phenylketonuria (PKU)
12/31/2007 Pharmacyclics Xcytrin Brain Cancer (secondary; metastases)
Source: Biomedtracker, analyst research reports

Indevus Pharmaceuticals (IDEV)
Drug/indication: Sanctura XR for overactive bladder
FDA decision date: Aug. 13

Clinical data suggests that Sanctura XR is the best drug in the overactive bladder class, which is a billion-dollar-plus market and growing. (You can't watch network news without seeing multiple ads for overactive bladder drugs.)

But therein lies the catch. Tiny Indevus and its not-so-much-bigger marketing partner Esprit Pharma have to figure out a way to convince doctors to prescribe Sanctura XR against Big Pharma competitors with very deep marketing pockets.

GPC Biotech (GPCB)
Drug/indication: Satraplatin for prostate cancer
FDA decision date: Aug. 15

Satraplatin is the first oral (pill) formulation of the commonly used platinum class of chemotherapy drugs. The phase III satraplatin study in men with advanced prostate cancer was a success, it hit all its efficacy endpoints, and data has been presented at numerous medical meetings, including this month's American Society of Clinical Oncology annual meeting.

1 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,563.30 -317.06 -1.88%
S&P 500 1,930.67 -39.40 -2.00%
NASDAQ 4,369.7730 -93.1290 -2.09%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs