Regulatory news injured a few biotech stocks on Monday, while others got a kick out of positive clinical news -- the balance a kind-of-down day for the sector.
Vanda (VNDA Quote) shares tanked after the Food and Drug Administration issued a non-approvable letter for its lead candidate, antipsychotic drug iloperidone. Shares gave up $2.46, or 73%, to 90 cents. The FDA requested an efficacy study that could take up to a year and a half and cost $35 million, as well as additional long-term safety data that could take two years to complete.
The company said in a conference call that under the capital available to the company today, it would not be able to conduct both the additional efficacy study and the additional safety exposures, but its first step is more discussions with the FDA to clarify the agency's thinking and any alternatives. ...
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