|Company name||Aradigm Corporation|
|Class period||July 27, 2017 – January 8, 2018|
|Lead plaintiff deadline||March 12, 2018|
|Court||Northern District of California|
NEW YORK, January 12, 2018 – Bragar Eagel & Squire, P.C. reminds investors that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California on behalf of all persons or entities who purchased or otherwise acquired Aradigm Corporation (NASDAQ: ARDM) securities between July 27, 2017 and January 8, 2018 (the “Class Period”). Investors have until March 12, 2018 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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, 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.
On January 9, 2018, the FDA announced that it would discuss Aradigm’s Linhaliq NDA at the Antimicrobial Drugs Advisory Committee meeting scheduled for January 11, 2018. The FDA stated that “[r]easons for the discordance in efficacy findings between trials cannot be explained based on the information collected in the two trials” underlying the Linhaliq NDA and that, with respect to the clinical trials’ endpoint, “it is unclear that delaying the time to first exacerbation on study therapy compared to placebo over approximately one year of observation translates into a clinically meaningful benefit for a patient population that would most likely be on this therapy for long durations.”
On this news, Aradigm’s share price fell $2.28, or 38.12%, to close at $3.70 per share on January 9, 2018.
If you purchased or otherwise acquired Aradigm securities during the Class Period or continue to hold shares purchased prior to the Class Period, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at firstname.lastname@example.org, or telephone at (212) 355-4648, or by filling out the contact form below. There is no cost or obligation to you.