Aradigm Corporation

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According to the lawsuit, defendants during the Class Period made materially false and/or misleading statements and/or failed to disclose that: (1) the methodology underlying Aradigm’s Linhaliq Phase III clinical trials was not well tailored to yield consistent efficacy findings or to provide data sufficient to account for discordant efficacy findings; (2) the endpoint of the Phase III trials—namely, delaying the time to first exacerbation on study therapy compared to placebo over approximately one year of observation—was unlikely to demonstrate a clinically meaningful benefit with respect to a patient population that would likely be taking the drug for a longer duration; (3) accordingly, these studies were unlikely to support FDA approval of the Linhaliq NDA; and (4) as a result, Aradigm’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

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