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) and Takeda
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.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- 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 + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV