Chelsea's Northera NDA reportedly approved, shares halted

A decision for the Northera new drug application was postponed from last Friday due to an office closure caused by severe weather.

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  • Jack Wildcat
    , contributor
    Comments (222) | Send Message
    Boom goes the dynamite!
    18 Feb 2014, 04:52 PM Reply Like
  • bwy23
    , contributor
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    LOL Tosh.O reference Nice 1
    19 Feb 2014, 12:53 AM Reply Like
  • Chris DeMuth Jr.
    , contributor
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    "The FDA is approving Northera under the accelerated approval program, which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment). This program provides patient access to promising drugs while the company conducts post-approval clinical trials to verify the drug's clinical benefit, which for this approval is a long-term effect on patient symptoms in NOH, a chronic disease.
    Northera has a boxed warning to alert health care professionals and patients about the risk of increased blood pressure while lying down (supine hypertension), a common problem that affects people with primary autonomic failure and can cause stroke. It is essential that patients be reminded that they must sleep with their head and upper body elevated. Supine blood pressure should be monitored prior to and during treatment and more frequently when increasing doses.
    The most common adverse events reported by clinical trial participants taking Northera were headache, dizziness, nausea, high blood pressure (hypertension) and fatigue.


    The effectiveness of Northera was shown through two-weeks in two clinical trials in people with NOH. People taking Northera reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared to those taking an inactive pill (placebo). Durability of the improvement in patient symptoms beyond two weeks has not been demonstrated."
    18 Feb 2014, 04:54 PM Reply Like
  • Chris DeMuth Jr.
    , contributor
    Comments (11754) | Send Message
    Chelsea Therapeutics Announces FDA Accelerated Approval of NORTHERA™ (Droxidopa) for the Treatment of Symptomatic NOH:
    18 Feb 2014, 04:59 PM Reply Like
  • Joe McCann
    , contributor
    Comments (268) | Send Message
    18 Feb 2014, 05:00 PM Reply Like
  • GreenGrowthGeek
    , contributor
    Comments (2267) | Send Message
    The stock should settle in at $8.00 to $9.00 in the coming days if Deutsche Bank is correct. If sales are better than expected then D Bank says shares could pop above $12. I think the warnings etc...aren't a big drag--they were expected. The FDA news looks very good, no huge red flags in my view. I'm glad I rolled the dice a bit on this one as I just bought in less than two weeks ago. That 16-1 vote had me convinced that the odds were above 90% for approval.
    18 Feb 2014, 09:10 PM Reply Like
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