This Day On The Street
Continue to site
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

Biotech Stock Mailbag: Osiris, Arena, Ampio

In other words, in order to show any survival advantage for Prochymal protocol 275, not only did Osiris need to employ a dubious historical control group, but it had to separate the GVHD patients by disease severity.

Osiris has never adequately explained why Prochymal benefits children with GVHD but not adults, nor has it explained why Prochymal only seems to prolong survival in children with more severe grades of GVHD while not helping less sick patients.

When Canada granted conditional approval for Prochymal in May, Osiris CEO Randy Mills told the New York Times that the company filed first in Canada because the U.S. Food and Drug Administration had told the company it would need additional data before seeking approval here.

The newly released Canadian regulatory documents show our neighbors to the North, despite approving Prochymal, are not yet convinced that the stem cell therapy benefits GVHD patients. FDA isn't going to be as lenient, which puts Osiris in a tough spot fundamentally, even if it has momentum traders on its side for now.

@zortrades asks, "What is your take on $ARNA?"

There's frenzied trading in Arena Pharmaceuticals (ARNA - Get Report) ahead of the June 27 FDA approval decision for the weight-loss drug lorcaserin. Take a look at the StockTwits heat map for health care: The trader twitter chatter is dominated by Arena! [StockTwits executive editor Phil Pearlman has more details on the incredible <a href="" rel="nofollow">4,321% rise in social media traffic for Arena</a> over the past three months. Staggering numbers.]

It was noted by someone else (I don't know who) that FDA announced the three-month delay in the Vivus (VVUS - Get Report) Qnexa review eight days before the approval decision date. We are now past that eight-day mark for Arena, so perhaps the risk of a similar delay for lorcaserin is diminished, if not gone entirely.

I'm predicting full approval of lorcaserin on June 27. Of course, I've been wrong about Arena and lorcaserin in the past, so...

I can't help but think that momentum traders are largely behind Arena's run-up into the FDA decision date. Short covering and a cult-like retail investor following are helping, too. [Don't believe me? Check out the message board where Arena cult leaders rant endlessly about the evils of short selling and threaten to sue anyone for criminal conspiracy just because they don't like the stock.] At some point, traders will take profits, leaving Arena's stock price vulnerable. Whether that happens immediately upon lorcaserin's approval or days later isn't clear to me. Your guess is as good as mine.
4 of 6

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr 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

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ARNA $2.15 0.00%
AMPE $3.58 0.00%
OSIR $10.38 0.00%
VVUS $1.38 0.00%
AAPL $117.81 0.00%


Chart of I:DJI
DOW 17,798.49 -14.90 -0.08%
S&P 500 2,090.11 +1.24 0.06%
NASDAQ 5,127.5250 +11.3820 0.22%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs