Shares of Chelsea Therapeutics soared 160 percent before the markets opened Wednesday, a day after a panel of federal experts recommended the approval of its blood pressure treatment Northera.
A Food and Drug Administration panel of outside experts voted 16-1 on Tuesday in favor of approving the drug, which the FDA had rejected in 2012. The panel's decision stands at odds with the FDA, which has cited lack of evidence regarding the drug's long-term effectiveness. Northera is designed to prevent dizziness and fainting in Parkinson's disease patients.
Some panelists said their endorsement came with the condition that the drug only be approved for short-term use and in a narrowly defined group of patients. The experts stressed that the drug should not be used generally to treat dizziness.
The FDA is scheduled to make a decision on the drug next month. It is not required to follow the group's advice, though it often does.
Wedbush analyst Liana Moussatos estimates about a 65 percent chance of approval on or by the FDA's Feb. 14 decision date. Moussatos believes the advisory panel's overwhelmingly positive vote may sway the agency.
She added that the panel appeared to appreciate "the vagaries of clinical trials for neurological disorders" and the lack of a good alternative treatment.
"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," the analyst wrote.
The Charlotte, N.C., company has no drugs approved for sale. Northera is its most advanced candidate.
Shares of Chelsea Therapeutics International Ltd. began climbing Tuesday evening after markets closed. The stock's price had more than doubled to $5.97 more than an hour before markets opened Wednesday.
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