The Klein Law Firm announces that a class action complaint has been filed on behalf of shareholders of Aradigm Corporation (NASDAQ: ARDM) who purchased shares between July 27, 2017 and January 8, 2018. The action, which was filed in the United States District Court for the Northern District of California, alleges that the Company violated federal securities laws.
In particular, the complaint alleges 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 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. On January 9, 2018, the 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. 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 the FDA recommended Aradigm conduct “two independent trials” to provide evidence supporting the drug’s “overall demonstration of efficacy and safety.”
Shareholders have until March 12, 2018 to petition the court for lead plaintiff status. Your ability to share in any recovery does not require that you serve as lead plaintiff. You may choose to be an absent class member.
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