The FDA has turned thumbs down on IDM Pharma's mifamurtide, which was developed to treat a rare form of bone cancer. The agency is looking for more clinical data, says IDM, adding that company officials anticipated that move last July. Of course, IDM got a strong signal on their chances in May, when an advisory committee voted the drug down, saying the application was light on efficacy data. The company adds they'll be able to respond to the agency's demands by the first quarter of next year. It expects that the supplemental information and an amended NDA will prevent any demands for a new trial.
That wasn't enough to assuage many investors, who saw the value of IDM shares drop 25 percent on the news. The drug, formerly called Junovan, targets the often fatal non-metastatic osteosarcoma, which primarily afflicts children and young adults.
- see this release
- here's the report from RTT News
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