Breaking

U.S. Natural Gas Futures Drop Below $3 for First Time Since 2012
Tweet TWEET

Chelsea Therapeutics Issues Statement Regarding Postponement of NORTHERA(TM) (Droxidopa) NDA PDUFA Action Date Due to Severe

Chelsea Therapeutics Issues Statement Regarding Postponement of NORTHERA(TM)
(Droxidopa) NDA PDUFA Action Date Due to Severe Weather

CHARLOTTE, N.C., Feb. 14, 2014 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today issued the following statement
regarding the U.S. Food and Drug Administration (FDA) Prescription Drug User
Fee Act (PDUFA) action date for the Company's NORTHERA™ (droxidopa) New Drug
Application (NDA):

"As a result of severe weather conditions leading to an office closure, FDA
today notified Chelsea Therapeutics that the goal date for the Company's
NORTHERA NDA has been extended to the next business day, or Tuesday, February
18, 2014."

About Chelsea Therapeutics

Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company
that acquires and develops innovative products for the treatment of a variety
of human diseases, including central nervous system disorders. Chelsea
acquired global development and commercialization rights to droxidopa
(L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma Co., Ltd. in 2006,
excluding Japan, Korea, China and Taiwan. For more information about the
Company, visit www.chelseatherapeutics.com.

This press release contains forward-looking statements regarding future events
including our intention to pursue the development of NORTHERA . These
statements are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These include reliance on key
personnel and our ability to attract and/or retain key personnel; the risk
that FDA will not agree that our clinical trial results demonstrate the safety
and effectiveness of droxidopa; the risk that the FDA will not accept our
proposal regarding any trial or other data to support a new drug application;
the risk that the FDA will not approve the resubmitted NDA; the risk that our
resources will not be sufficient to conduct any study of Northera that will be
acceptable to the FDA; the risk that we cannot complete Study 401 or any other
additional study for Northera without the need for additional capital; the
risks and costs of drug development and that such development may take longer
or be more expensive than anticipated; our need to raise additional operating
capital in the future; our reliance on our lead drug candidate droxidopa; the
risk that we will not be able to obtain regulatory approvals of droxidopa or
our other drug candidates for additional indications; the risk of volatility
in our stock price, related litigation, and analyst coverage of our stock;
reliance on collaborations and licenses; intellectual property risks; our
history of losses; competition; market acceptance for our products if any are
approved for marketing.

CONTACT: Media:
         David Connolly
         LaVoie Group
         617-374-8800, Ext. 104
         dconnolly@lavoiegroup.com
        
         Investors:
         Susan Kim
         Argot Partners
         212-600-1902
         susan@argotpartners.com

Chelsea Therapeutics Logo
 
Press spacebar to pause and continue. Press esc to stop.