Vanda Pharmaceuticals Inc. (VNDA) said that its antipsychotic drug, iloperidone, performed well in a late-stage clinical trial, adding that a New Drug Application for it likely will be filed with federal regulators late next year.
Separately, Vanda Chief Executive Mihael Polymeropoulos said during a CNBC interview Thursday that various pharmaceutical companies have expressed interest in buying his company because of its pipeline of products.
The dual developments sent shares of Vanda, a Rockville, Md.-based biotech company, soaring to a 52-week high of $28.67 in early trading, up 85% from Wednesday's close and surpassing a previous 52-week high of $17 set Nov. 15.
The shares were trading recently at $26.31, up $10.81, or about 70%. Volume was 5.12 million shares traded, compared to a daily average of 312,000.
Vanda executives said the Phase III clinical trial evaluated iloperidone, an atypical antipsychotic, in patients with schizophrenia. The drug demonstrated statistically significant improvement compared to placebo on the Positive and Negative Symptom Scale, the trial's primary endpoint, they said.
Paolo Baroldi, Vanda's chief medical officer, said in a prepared statement that the successful trial means the company is getting closer to filing a New Drug Application for iloperidone with the Food and Drug Administration, which is expected in late 2007. The company also is "one step closer to making iloperidone available to patients and providers dealing with schizophrenia," Baroldi said.
JP Morgan concurred in a research note, saying the Phase III results are sufficient for the NDA filing expected in late 2007.
Meanwhile, Vanda's Polymeropoulos said during his CNBC interview that no decisions have been made regarding a possible sale of the company, although he said many suitors likely would be interested.
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