Small-cap healthcare company Chelsea Therapeutics (CHTP) saw shares spike on Wednesday after the FDA granted accelerated approval to Northera, its symptomatic neurogenic orthostatic hypotension (NOH) treatment. Chelsea was up over 25 percent in early trading on very heavy volume, with 30 million shares moved by 1 PM against an average daily volume of just under 8 million.
"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 Chelsea President and CEO Joseph G. Oliveto. "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."
Northera treats low blood pressure as it presents itself in patients suffering from neurological disorders like Parkinson’s Disease. It’s described in the company’s press release as follows:
“Symptomatic NOH is an autonomic nervous system disorder caused by failure to produce and or release adequate amounts of norepinephrine upon standing. Norepinephrine deficiency results in an inability for a person to maintain adequate blood pressure and blood flow to the brain when upright… The disorder affects an estimated 80,000 to 150,000 individuals in the United States.”
Northera’s acceleration comes as a result of the medication being a unique treatment for a serious condition. The need in the market for an effective treatment clearly influenced the FDA in their decision to accelerate approval.
"Symptomatic NOH is a commonly debilitating disorder with limited treatment options and no new therapeutic choices introduced in nearly two decades," said Director of the Parkinson's Disease Movement Disorders Center at the University of South Florida Dr. Robert A. Hauser. "NORTHERA has a distinct mechanism of action affecting the root cause of NOH and represents an important new treatment choice for patients. … I look forward to offering this new and novel treatment approach to patients who may benefit from it."
This continues a stellar 2014 for Chelsea, which has gained over 175 percent since the FDA announcement that Northera would be considered for accelerated approval. Today’s gains take the company’s stock over $6.30 a share, territory it hasn’t seen since January of 2011. This could represent a new stage for Chelsea, which has operated as a pre-revenue company prior to the approval of Northera.
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