|Company Name||Aradigm Corporation|
|Class Period||July 27, 2017 to January 08, 2018|
|Lead Plaintiff Motion Deadline||March 12, 2018|
On January 9, 2018, the U.S. Food and Drug Administration (“FDA”) released its briefing document for the January 11, 2018 meeting of the Antimicrobial Drugs Advisory Committee to discuss the New Drug Application for Linhaliq™ for the proposed indication of treatment of non-cystic fibrosis bronchiectasis (“NCFB”). The FDA stated that “there were too many uncertainties with regard to duration of treatment, frequency of administration and endpoints to allow for reliance on a single Phase 3 trial” of the drug, and that the FDA recommended Aradigm conduct “two independent trials” to provide evidence supporting the drug’s “overall demonstration of efficacy and safety.”
On this news, shares of Aradigm fell significantly, thereby injuring investors.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) 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; (ii) 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; (iii) accordingly, these studies were unlikely to support FDA approval of the Linhaliq NDA; and (iv) as a result, Aradigm’s public statements were materially false and misleading at all relevant times.
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