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By Gene G. Marcial Bioenvision (BIVN
) has been popping, from 6 a share in August to 9.35 on Nov. 23. Its leading product, Clofarabine, for treating leukemia in children, may get Food & Drug Administration approval soon. Cory Kasimov of Oppenheimer, who rates the stock a buy, says three events may give it a boost: The FDA's oncology advisory panel is expected to review Clofarabine on Dec. 1 -- and he's convinced it will recommend an O.K. If so, it could get FDA approval by Dec. 30. That could push European approval by mid-2005. Developed with ILEX Oncology (ILXO
) (being acquired by Genzyme (GENZ
)), Clofarabine could be "the first drug to be initially labeled for pediatric oncology in over a decade," says Kasimov.
The drug has a market yearly potential of $400 million, says David Luci, CFO and general counsel. He believes it could also get approved for adult leukemia, a bigger market. Oppenheimer's Kasimov sees Bio-envision making a profit in 2006. When last mentioned in this column, on Mar. 22, it traded at 6.40. Kasimov has a 12-month target of 16. On Nov. 19, Bioenvision adopted a poison pill to thwart a rumored takeover bid by suitors, including Bristol-Myers Squibb (BMY
) and Genzyme. The top shareholder is billionaire George Soros, with a 27% stake.Note: Unless otherwise noted, neither the sources cited in Inside Wall Street nor their firms hold positions in the stocks under discussion. Similarly, they have no investment banking or other financial relationships with them. See Gene on Fridays at 1:20 p.m. EST on CNNfn's The Money Gang.