Isis Pharmaceuticals (ISIS) is slumping after documents produced by an FDA panel recommended that the agency only allow certified doctors to prescribe the company's mipomersen, also known as Kynamro. The documents recommended the restriction because it found that the drug - a treatment for the disorder HoFH which causes very high cholesterol - could allegedly cause liver damage. Only HoFH patients should receive the drug, while other people with high levels of cholesterol in their blood shouldn't be treated with mipomersen, the briefing documents stated. Moreover, the drug had caused several types of tumors in some animals "at clinically relevant exposures," according to the documents. In a note to investors earlier today, research firm Piper Jaffray wrote that the information about tumors is a negative surprise that will reduce the likelihood that an FDA panel will recommend approval of the drug when it meets on Thursday.
The firm downgraded the stock to Neutral from Overweight and lowered its target on the shares to $10 from $18. Meanwhile, shares of Aegerion (AEGR), which has also developed a treatment for HoFH, are rising for the second day in a row. FDA documents for Aegerion's drug, Lomitapide, released yesterday said that the drug increases liver fat, but that the process appears to be reversible. Furthermore, the documents reported that an increased amount of liver tumors appeared in mice only after being treated with the drug for two years. A small, statistically significant increase in intestinal tumors occurred in mice that received 25 times the amount of the drug that humans would be given. In late morning trading, Isis slumped $1.96, or 14.91%,
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