Shares of IDM Pharma Inc., an Irvine drug maker, fell 19% Monday after the company said the Food and Drug Administration denied approval for Junovan, IDM’s bone cancer drug.
Regulators wanted additional clinical trial data and other information, IDM said in a release. The company is working to gather the data and plans to submit an amendment to its drug application for Junovan by early next year.
Junovan is used to treat a rare form of bone cancer called non-metastatic osteosarcoma, which typically affects children and young adults and often is fatal.
IDM licensed the drug from Swiss drug maker Novartis SA.
IDM,still a development-stage company,counts a market value of $41 million.
Back in early April, IDM saw a stock spike, rising 167% after news that the drug maker was going to meet with regulators about Junovan. In May, however, IDM’s shares fell when a FDA panel recommended against approving Junovan.
