NEW YORK, Jan. 11, 2018 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Aradigm Corporation (“Aradigm” or the “Company”) (ARDM) and certain of its officers. The class action, filed in United States District Court, for the Northern District of California, and docketed under 18-cv-00261, is on behalf of a class consisting of investors who purchased or otherwise acquired the securities of Aradigm between July 27, 2017 and January 8, 2018, both dates inclusive (the “Class Period”). Plaintiff seeks to recover compensable damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder.
If you are a shareholder who purchased Aradigm securities between July 27, 2017, and January 8, 2018, both dates inclusive, you have until March 12, 2018, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and quantity of shares purchased.
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.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby