Shares of Vanda Pharmaceuticals Inc. (VNDA) surged over 40% on Wednesday morning after the U.S. Food and Drug Administration approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
VNDA is currently trading at $5.49, up $1.58 or 40.41%, on a huge volume of 35 million shares, compared to average volume of about 1 million, on the Nasdaq. The stock opened its trading at $4.66 after closing Tuesday at $3.91. The stock has traded between $3.30 and $7.00 in the past 52-week period.
Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.
"Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs. With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder," said Mihael H. Polymeropoulos M.D., Vanda's President, CEO and Chairman of the Board.
Bipolar disorder is a serious, highly prevalent psychiatric chronic condition affecting approximately 2.8% of the U.S. adult population, with 83% of them classified as severe. Bipolar disorder is a group of disorders that are characterized by periods of elevated mood alternating with periods of depressed mood.
For comments and feedback: editorial@rttnews.com