) to buy.
Analyst Patrick Mooney says his upgrade was based on fading noise surrounding ImClone's shares; increasing visibility into the clinical development program for Erbitux, its experimental cancer drug; and his belief that Erbitux clinical data from two pivotal clinical trials will be positive, and form the basis for both U.S. and European regulatory filings.
Mooney thinks the company's European partner Merck KGaA will show positive data from the trials, which should help secure Erbitux's European filing in June 2003 and its approval in June 2004. He expects positive data from an ImClone/Bristol Myers sponsored single agent study of Erbitux in chemo-refractory patients by the fourth quarter of 2003 with a U.S. filing by year-end. Mooney has a $15 12-month target.
The FDA originally rejected ImClone's Erbitux approval application on Dec. 28, 2001. The setback pushed ImClone shares sharply lower, and triggered shareholder lawsuits as well as investigations.