BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Chelsea Therapeutics, Inc. (CHTP) Expects to Resubmit Northera for FDA Approval in 2nd Quarter


2/21/2013 7:41:53 AM

Chelsea Therapeutics International Ltd plans to repitch its once-rejected hypotension drug Northera in the second quarter after a review by U.S. health regulators determined that the company could use its original data for the resubmission. Shares of Chelsea were up 93 percent at $1.48 in heavy volume trading on Wednesday on the Nasdaq. The stock traded around the $4 levels before the FDA rejection. "(Wednesday's news) was surprisingly positive given what the FDA reviewers earlier said," Liana Moussatos of Wedbush Securities said. The FDA's guidance was in response to a formal appeal by the company to the Director of the Office of New Drugs of the FDA, after the Cardiovascular and Renal Products committee denied approval to the drug last March, asking for another study to show long-term benefit. This means the FDA believes the data Chelsea had submitted last year for approval can serve as the basis for a resubmission of the marketing application of Northera, analyst Moussatos said. Northera is being tested for symptomatic neurogenic orthostatic hypotension, or a chronic drop in blood pressure on standing up that is most often associated with Parkinson's disease. The drug has an orphan drug status, or a seven-year marketing exclusivity from the day of approval. "We now have a regulatory path forward, including the potential for an approval of Northera later this year," said Chelsea's interim Chief Executive Joseph Oliveto. However, risks still remain as the Cardiovascular and Renal Products committee of the FDA, which rejected the drug last year, will be the one reviewing it after Chelsea resubmits its application, Moussatos added.


   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES