A lawsuit was filed on behalf of investors in Aradigm Corporation (NASDAQ:ARDM) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 01/22/2018 -- An investor, who purchased shares of Aradigm Corporation (NASDAQ:ARDM), filed a lawsuit over alleged violations of Federal Securities Laws by Aradigm Corporation.
Investors who purchased shares of Aradigm Corporation (NASDAQ:ARDM) should contact the Shareholders Foundation at email@example.com or call +1(858) 779 - 1554.
On January 9, 2018, the U.S. Food and Drug Administration ("FDA") released its briefing document for the Antimicrobial Drugs Advisory Committee meeting scheduled for January 11, 2018. The FDA plans to discuss Aradigm's New Drug Application for Linhalig TM for the proposed indication of treatment of non-cystic fibrosis bronchiectasis ("NCFB). The briefing document stated that "[t]he Agency recommended that two adequate and well-controlled clinical trials be conducted to supposed the NCFB indication because," among other things, "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," and "the conduct of two independent trials would be important in providing replicative evidence supporting an overall demonstration of efficacy and safety." NASDAQ:ARDM shares declined to $3.35 per share on January 9, 2018.
The plaintiff claims that between July 27, 2017 and January 8, 2018, the defendants made false and/or misleading statements and/or failed to disclose that 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, thatthe 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, that accordingly, these studies were unlikely to support FDA approval of the Linhaliq NDA, and that as a result, Aradigm's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Aradigm Corporation (NASDAQ:ARDM) have certain options and should contact the Shareholders Foundation.
Shareholders Foundation, Inc.
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