Vanda Shares Jumped 29% Amid Continued Success Of Hetlioz

Shares of Vanda Pharmaceuticals VNDA traded up more than 29 percent following the company's 8-K filing on Wednesday and Exhibit 99.1 presentation.

History of the Drug Application

On May 31, 2013, Vanda announced that it submitted a new drug application to the Food and Drug Administration (FDA). The company sought approval for Hetlioz (tasimelteon), to treat non-24 hour disorder in the totally blind. The drug would aid blind individuals with a rare, circadian rhythm disorder who cannot synchronize their body clock to the 24 hour day.

In November, the FDA Advisory Committee “overwhelmingly” voted to approve tasimelteon for the totally blind. The Committee found, “Non-24 is an appropriate indication for an FDA-approved therapy; the clinical endpoints are appropriate to support the indication; there is substantial evidence of tasimelteon efficacy in Non-24; and the safety of tasimelteon in Non-24 has been adequately addressed.”

On January 31, 2014, the FDA approved Hetlioz (tasimelteon), the first approved treatment for non-24 hour disorder.

Recent Developments

Vanda issued a press release on Tuesday stating that the Marketing Authorization for Hetlioz (tasimelteon) has been accepted for evaluation by the European Medicines Agency (EMA).

In the press release, Vanda's President and CEO Mihael H. Polymeropoulos, M.D, said, “The EMA submission is an important milestone towards providing a treatment option for people living with Non-24 in the European Union. This continues our efforts to expand the availability of HETLIOZ to markets outside the U.S.”

On Wednesday, the company filed an 8-K with a presentation regarding the drug. In the presentation, Vanda's total 2014 operating expenses are expected to be between $110 and $120 million. Year-end cash before the income from Hetlioz is expected to be within $20 and $30 million.

As of June 4, over 220 prescriptions were written for Hetlioz. Out of the prescriptions, 152 are new patients. Vanda reported that more than half of the prescriptions have filled and dispensed to date.

Stock Action

Shares of Vanda Pharmaceuticals closed at $12.56 on Wednesday. The stock is down over three percent at $12.14 in Thursday's session.