NEW YORK, Jan. 12, 2018 /PRNewswire/ -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Aradigm Corporation ("Aradigm" or the "Company") (ARDM) and certain of its officers, on behalf of shareholders who purchased Aradigm securities between July 27, 2017, and January 8, 2018, both dates inclusive ("Class Period"). Such investors are encouraged to join this case by visiting the firm's site: http://www.bgandg.com/ardm.
This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934.
Aradigm Corporation develops novel pulmonary drug delivery systems. The Company's systems are designed to enhance the delivery and effectiveness of a number of existing and development stage drugs and reduce the need for injectable drug therapy. On July 27, 2017, Aradigm submitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for U.S. marketing approval for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections.
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 the Complaint alleges that, Defendants made 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) as a result, these studies were unlikely to support FDA approval of the Linhaliq NDA; and (4) consequently, Aradigm's public statements were materially false and misleading at all relevant times.
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 ™ 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." Following this news, Aradigm stock dropped $2.28 per share, or 38.12%, to close at $3.70 per share on January 9, 2018.
A class action lawsuit has already been filed. If you wish to review a copy of the Complaint you can visit the firm's site: http://www.bgandg.com/ardm or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss in Aradigm you have until March 12, 2018 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Yael Hurwitz
212-697-6484 | firstname.lastname@example.org
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