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

Biotech Stock Mailbag: 2013 Clinical Trials Calendar

Stocks in this article: INSM MNKD ALNY OREX KERX BIOD GTXI MACK RMTI CCXI ACHN FOLD

BOSTON ( TheStreet) -- I'm just back from covering the American Society of Clinical Oncology (ASCO) annual meeting -- and still recovering -- so apologies in advance for a less-full Biotech Stock Mailbag this week.

Bruce L. writes:

Besides the FDA Drug Approval Calendar, it would be helpful to know when phase III results are going to be announced. I just stumbled upon Insmed (INSM), which will announce phase III results soon and the stock has run from $3 to $11 in a few months. The run-up is where you can make a lot of money without the risk of the FDA. Publishing a list of quarterly clinical trial results would be very helpful. Keep up the good work!"

Insmed's lead product is Arikace, an inhaled antibiotic engineered to deliver an already-approved antibiotic known as amikacin directly into the lungs of patients with rare lung infections. Arikace is being studied in a phase III clinical trial of cystic fibrosis patients, with results expected in the middle of the year. This study is intended for an approval filing in Europe and Canada.

The FDA imposed a clinical hold on a similar Arikace study in the U.S., which was later lifted, but Insmed's plans to develop the antibiotic here are still unclear, pending results from the European study. Insmed is also conducting a phase II study of Arikace in patients with non-tuberculous mycobateria (NTM) lung disease and a nine-month dog toxicity study.

Results from Insmed's NTM study are expected in the fourth quarter.

Bruce's overall point about the stock-moving power of clinical trial results is a good one. Take a look at what happened to Clovis on Monday if you're a doubter.

Here's a rundown of companies with significant clinical trial results expected this year:

MannKind (MNKD)
Afrezza, Type 1 and 2 diabetes
Top-line results from two phase III studies expected in August.
After two FDA rejections, MannKind is back seeking another shot at approval of its inhaled, fast-acting insulin. The data from these two phase III studies, if positive, will form the basis of the Afrezza resubmission.

Vical (VICL)
Allovectin for melanoma
Top-line results from a phase III study expected in the third quarter
The long-delayed Allovectin study is finally almost complete. I explained the bear thesis on Vical and Allovectin in a previous Mailbag.

Orexigen Therapeutics (OREX - Get Report) and Takeda
Contrave, obesity
Interim analysis of the cardiovascular outcomes study could take in the second or third quarter.
Under an agreement with FDA, Orexigen and its partner Takeda will conduct an interim analysis of the Contrave study once 87 major adverse cardiovascular events have been recorded. If the interim analysis returns clean heart-safety data for Contrave, the obesity drug will be resubmitted to FDA for a second review.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!

Markets

DOW 17,387.21 -291.49 -1.65%
S&P 500 2,029.55 -27.54 -1.34%
NASDAQ 4,681.4970 -90.2660 -1.89%

Partners Compare Online Brokers

Free Reports

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