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

FDA Hurdle Hits Amylin, Alkermes (Update)

Amylin, which currently markets twice-daily Byetta with third partner Eli Lilly (LLY - Get Report), is also up against a competitive time crunch to get its once-weekly product approved. Its competitor Novo Nordisk (NVO - Get Report) has already submitted its application for a once-daily injection and pending the outcome of a panel in March, could have its product approved by mid-2009.

Amylin isn't the first company to face pressure from the FDA to show that products manufactured at separate plants are the same. Genzyme's (GENZ) Myozyme produced at a new, larger-scale manufacturing facility was considered a different product than the already-approved product, causing unforeseen regulatory delays.

The potential setback disclosed in the Alkermes SEC filing on Tuesday isn't Amylin's first for the year. Amylin's shares have been depressed on reports of pancreatitis, and in some cases death, of patients taking its twice-daily Byetta, although there is no known link between the drug and pacreatitis.

Eastbourne Capital, which owned a nearly 13% stake in Amylin as of late August, said earlier in the week that it intends to hold discussions with management, other shareholders and third parties, regarding actions that could enhance shareholder value, including a possible sale of the company.

For more stories like this, check out our Biotech Stock section.
2 of 2

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
ALKS $39.75 0.00%
LLY $75.53 0.00%
NVO $55.79 0.00%
AAPL $93.74 0.00%
FB $117.58 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs