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

Chelsea Therapeutics Reports First Quarter 2013 Financial Results

CHARLOTTE, N.C., May 1, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the first quarter ended March 31, 2013.

"In the first quarter, we made significant progress toward the commercialization of Northeraâ„¢ (droxidopa) for the treatment of symptomatic Neurogenic Orthostatic Hypotension, a debilitating orphan condition that is greatly in need of alternative therapies," said Joseph G. Oliveto, Interim CEO of Chelsea. "Our team has navigated through the significant challenges of showing a symptomatic benefit in this difficult to treat disease state, and now, with updated guidance from the U.S. Food and Drug Administration, we have a regulatory path forward toward review and potential approval this year. We remain focused on resubmission of a New Drug Application for Northera in NOH."

First Quarter Highlights

  • In February 2013, Chelsea received written guidance from the Director of the Office of New Drugs at the U.S. FDA stating that Study 306B has the potential to serve as the basis for a resubmission of a Northera NDA for the treatment of symptomatic NOH. The Company intends to resubmit the Northera NDA in the second quarter or the early weeks of the third quarter of 2013. Chelsea also intends to initiate a new clinical trial in the fourth quarter of 2013, given FDA guidance regarding the potential need for Chelsea to verify the durability of effect of Northera in a post-marketing study.  
  • In March 2013, the results from Studies 306A and 306B were presented at the American Academy of Neurology's 65th Annual Meeting, where they were featured as part of the 2013 Emerging Science Program and highlighted by the AAN both in a data blitz and press release titled "New Drugs May Improve Quality of Life for People with Parkinson's Disease".

Financial Results for the First Quarter

For the quarter ended March 31, 2013, Chelsea reported a net loss of $3.9 million or ($0.06) per share versus a net loss of $15.6 million or ($0.23) per share for the same period in 2012.

1 of 3

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
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!
SYM TRADE IT LAST %CHG

Markets

DOW 17,888.86 -87.45 -0.49%
S&P 500 2,077.15 -9.09 -0.44%
NASDAQ 4,925.04 -22.4010 -0.45%

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