Vanda Pharmaceuticals Inc. (VNDA) gained the most in four years after U.S. regulators said they would give a priority review to the company’s treatment for sleep disorders.
The Food and Drug Administration will expedite the application process for tasimelteon, which treats blind people with Non-24-Hour Disorder, a condition of the body’s circadian rhythm, the Rockville, Maryland-based company said yesterday in a statement. If approved, the drug would become Vanda’s second product, joining Fanapt, a schizophrenia drug marketed in the U.S. by Novartis AG.
Vanda’s shares jumped 42 percent to $11.42 at 2:23 p.m. New York time, after earlier reaching $11.53 for the biggest intraday gain since May 2009. The stock had more than doubled this year through yesterday.
There is no approved treatment for Non-24-Hour Disorder, which occurs when the blind are unable to synchronize their internal body clock with the 24-hour daily cycle, Vanda said in the statement.
The FDA scheduled an advisory panel meeting for Nov. 14 on tasimelteon, which seeks to reset the body’s internal clock and align it with the day-night cycle. The agency plans to decide on the drug’s approval by Jan. 31, the company said.
Vanda, which has reported annual net losses the past two years, will announce quarterly earnings tomorrow.
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