Jan 15 Chelsea Therapeutics International Ltd's
shares more than doubled in value on Wednesday after an
independent panel to the U.S. health regulator recommended an
approval for the company's drug to treat a rare form of low
Chelsea's shares jumped as much as 151 percent to $5.78,
touching their highest in two and a half years and valuing the
company at $453 million.
Analysts, however, were cautious as the U.S. Food and Drug
Administration rejected the drug in March 2012 even after a
positive recommendation from an advisory committee and cited the
need for more data.
The panel voted 16 to 1 in favor of the drug, Northera, on
"A degree of caution may be prudent until the FDA responds,
however, given strength of regulatory opposition to the drug to
date," Needham analyst Alan Carr wrote in a note.
Carr raised his price target on the stock to $8 from $4.
The FDA usually follows the recommendation of advisory
panels, but is not bound to do so.
In briefing documents published on Friday before the panel's
meeting, FDA reviewers said the drug was not effective enough to
Analysts said testimonials from patients about the drug's
efficacy could have influenced the panel to vote in favor of
"There were multiple patients and caregivers whose dramatic,
life-altering change with treatment may have softened the
nitpicking about apparent variable efficacy in the trials,"
Wedbush analyst Liana Moussatos wrote in a note.
Northera, known generically as droxidopa, is intended to
treat neurogenic orthostatic hypotension, a prolonged drop in
blood pressure upon standing that causes dizziness, fainting and
The condition, which occurs mostly in the elderly, is
associated with nervous system disorders, such as Parkinson's
The FDA is expected to review the drug by Feb. 14.
At least one analyst said the review time could be extended
by three months beyond Feb. 14 as the company reaches an
agreement with the regulator on the product label, risk
management strategy and post-approval requirements.
Chelsea shares were up 118 percent at $5.01 on Wednesday
morning on the Nasdaq.
(Reporting by Vrinda Manocha in Bangalore; Editing by Kirti