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

Amicus Therapeutics Announces First Quarter 2013 Financial Results And Corporate Updates

12-Month Results From Ongoing Phase 3 Fabry Disease Monotherapy Study Anticipated 3Q13

Phase 2b Pompe Co-Administration Study on Track to Begin 3Q13

CRANBURY, N.J., May 9, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the first quarter ended March 31, 2013. The Company also summarized recent and upcoming milestones and reiterated full-year 2013 operating expense guidance.

Key Highlights and Upcoming Milestones:
  • 12-month results from first ongoing Phase 3 Fabry monotherapy study ( Study 011) anticipated 3Q13. FDA will consider entirety of 6- and 12-month data for potential U.S. approval of migalastat HCl monotherapy.
  • Phase 2b repeat-dose clinical study of AT2220 (duvoglustat HCl) co-administered with ERT (Myozyme®/Lumizyme®) for Pompe disease expected to begin 3Q13.
  • IND submission for Fabry chaperone-ERT co-formulated product planned by year-end 2013 for potential entry into clinic in early 2014.
  • Next-generation ERTs for Pompe disease and other LSDs advancing in preclinical studies.

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics stated, "Amicus had a productive first quarter that was largely focused on the execution of clinical and regulatory activities for migalastat HCl monotherapy for Fabry disease, our upcoming clinical studies in Fabry and Pompe, and the build out of our CHART platform. A Type C meeting with the FDA will take place during the second quarter to discuss the statistical analysis plan for Study 011 while the 12-month data are still blinded. We remain on track to unblind and announce these 12-month results in the third quarter. We are also finalizing the design of our repeat-dose Phase 2b co-administration study for Pompe disease, which we expect to begin in the third quarter. Our strong financial position will continue to support the advancement of these programs as we approach several key milestones throughout the remainder of 2013."

1 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
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 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