Chelsea Therapeutics International Ltd. (CHTP) stock took off — up 36% in extended trading Tuesday — following the FDA’s approval of its blood pressure drug.
CHTP stock was up 35% after the opening bell today.
The FDA approved the drug Northera (droxidopa) as treatment of symptomatic neurogenic orthostatic hypotension, or NOH.
“The approval of NORTHERA is an extraordinary achievement, one for which I thank patients and their families, investigators and the medical community, our partner Dainippon Sumitomo, and our employees,” said Joseph G. Oliveto, President and Chief Executive Officer of Chelsea Therapeutics.
“We will now turn our efforts towards delivering NORTHERA to patients with NOH in the United States, an important goal we expect to achieve in the second half of the year.”
Chelsea Therapeutics stated that Northera, an orally active synthetic precursor of norepinephrine, is the only FDA approved drug to benefit in patients with symptomatic NOH.
It is the first new treatment for symptomatic NOH in nearly 20 years.
The NORTHERA approval was granted under the FDA’s accelerated approval program, which allows for conditional approval of a medicine that fills a serious unmet medical need, provided additional confirmatory studies are conducted.
CHTP stock is up some 781% from last year.