Aradigm’s attempt to commercialize an inhalable version of a generic antibiotic as a treatment for chronic lung infections has stalled with the FDA’s rejection of the company’s drug approval application.
Hayward, CA-based Aradigm (NASDAQ: ARDM) says it would be required to conduct another Phase 3 study of its version of ciprofloxacin (Linhaliq) in order to resubmit the application. The FDA’s rejection comes three weeks after an advisory committee to the regulator voted against recommending approval for the Aradigm drug.
Shares of Aradigm fell nearly 25 percent to $1.68 apiece following the announcement of the news on Monday.
Aradigm has spent… Read more »
UNDERWRITERS AND PARTNERS