This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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
TheStreet Open House

31 Drugs Facing FDA Approval in 2012-2013

BOSTON ( TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012 and into early 2013. This refresh includes changes and additions to the FDA calendar last published at the end of July.

The calendar on the following pages captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between August and March 2013. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst.

Gilead Sciences (GILD)
Drug/indication: Quad for HIV
Approval decision date: Aug. 27
Quad combines four Gilead drugs into a single, once-daily pill for HIV. The new (and still experimental) components in the Quad are the integrase inhibitor elvitegravir and cobicistat, which is used to boost blood levels of elvitegravir.

Pfizer (PFE)
Drug/indication: Tofacitinib for rheumatoid arthritis
Approval decision date: August (exact date not specified)
Tofacitinib would be the first pill approved for the treatment of rheumatoid arthritis, competing with established injectable drugs like Abbbot's Humira.

Ironwood Pharmaceuticals (IRWD)
Drug/indication: Linaclotide for chronic idiopathic constipation and irritable bowel syndrome
Approval decision date: Sept. 7

Navidea Biopharmaceuticals (NAVB)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: Sept. 10

Sanofi (SNY)
Drug/indication: Aubagio for multiple sclerosis
Approval decision date: Sept. 12

Cornerstone Therapeutics (CRTX)
Drug/indication: Lixivaptan for hyponatremia
FDA advisory panel: Sept. 13
Approval decision date: Oct. 29

Regeneron Pharmaceuticals (REGN)
Drug/indication: Eylea for Retinal Vein Occlusion (RVO)
Approval decision date: Sept. 21
This is an additional indication for currently approved Eylea.

Bristol-Myers Squibb (BMY)
Drug/indication: Metreleptin for lipodystrophy
Approval decision date: Oct. 3

Celgene
Drug/indication: Abraxane for non-small cell lung cancer
Approval decision date: Oct. 12
Abraxane is already approved for the treatment of breast cancer.

Bayer and Onyx Pharmaceuticals (ONXX)
Drug/indication: Regorafenib for metastatic colon cancer
Approval decision date: Oct. 15-30 (No specific date disclosed)

Santarus (SNTS)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Oct. 16

Aegerion Pharmaceuticals (AEGR)
Drug/indication: Lomitapide for dyslipidemia/hypercholesterolemia
FDA advisory panel: Oct. 17
Approval decision date: Dec. 28

Sanofi and Isis Pharmaceuticals (ISIS)
Drug/indication: Kynamro for dyslipidemia/hypercholesterolemia
FDA advisory panel: Oct. 18
Approval decision date: Jan. 29, 2013

Impax Labs (IPXL)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Oct. 19

Hyperion Therapeutics (HPTX)
Drug/indication: Ravicti for urea cell disorders
Approval decision date: Oct. 23

United Therapeutics (UTHR)
Drug/indication: Oral Remodulin for pulmonary arterial hypertension
Approval decision date: Oct. 26

Exelixis (EXEL)
Drug/indication: Cabozantinib for medullary thyroid cancer
FDA advisory panel: Nov. 9
Approval decision date: Nov. 29

1 of 2

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 17,190.47 +216.16 1.27%
S&P 500 0.00 -2.75 -0.14%
NASDAQ 4,564.9790 +15.7530 0.35%

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