Lawsuit Overview
May 9, 2018 - The case was voluntarily dismissed.
January 11, 2018 - An investor in shares of Aradigm Corporation (NASDAQ:ARDM) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by Aradigm Corporation in connection with certain allegedly false and misleading statements made between July 27, 2017 and January 8, 2018.
Hayward, CA based Aradigm Corporation is a pharmaceutical company focused on the development and commercialization of products for the treatment and prevention of severe respiratory diseases. Aradigm Corporation reported that its annual Total Revenue declined from $33.56 million in 2014, respectively $23.43 million in 2015, to $0.20 million in 2016 and that its Net INcome of $4.65 million declined to a Net loss of $17.21 million in 2015, respectively $32.94 million in 2016.
Shares of Aradigm Corporation (NASDAQ:ARDM) grew from $0.80 per share in Nmay 2017 to as high as $7.35 per share in late December 2017.
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.
According to the complaint the plaintiff alleges on behalf of purchasers of Aradigm Corporation (NASDAQ:ARDM) common shares between July 27, 2017 and January 8, 2018, that the defendants violated Federal Securities Laws. More specifically, 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.