NEW YORK, NY / ACCESSWIRE / December 16, 2020 / Pomerantz LLP announces that a class action lawsuit has been filed against certain officers of Celsion Corporation ("Celsion" or the "Company") (NASDAQ:CLSN). The class action, filed in United States District Court for the District of New Jersey, and docketed under 20-cv-015228, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Celsion securities between November 2, 2015 and July 10, 2020, both dates inclusive (the "Class Period"), seeking to recover 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, against the Company and certain of its top officials.
If you are a shareholder who purchased Celsion securities during the class period, you have until December 28, 2020, 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 [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Celsion is an integrated development clinical stage oncology drug company that focuses on the development and commercialization of directed chemotherapies, DNA-mediated immunotherapy, and RNA-based therapies for the treatment of cancer.
Celsion's lead product candidate is ThermoDox, a heat-activated liposomal encapsulation of doxorubicin that is in Phase III clinical development for treating primary liver cancer.
In February 2014, Celsion announced that the U.S. Food and Drug Administration ("FDA") had reviewed and provided clearance for the Company's planned pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox in combination with radio frequency ablation ("RFA") in primary liver cancer, also known as hepatocellular carcinoma ("HCC"), called the "OPTIMA Study." The trial design was purportedly based on a comprehensive analysis of data from the Company's Phase III HEAT Study, which purportedly demonstrated that treatment with ThermoDox resulted in a 55% improvement in overall survival ("OS") in a substantial number of HCC patients that received an optimized RFA treatment.
The OPTIMA Study was expected to enroll 550 patients globally, with up to 100 sites in the U.S., Europe, China and Asia Pacific, to evaluate ThermoDox in combination with RFA. The primary endpoint for the trial was OS, and the statistical plan called for two interim efficacy analyses by an independent Data Monitoring Committee ("DMC").
The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading because they misrepresented and failed to disclose the following adverse facts pertaining to the Company's business, operations, and prospects, which were known to Defendants or recklessly disregarded by them. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had significantly overstated the efficacy of ThermoDox; (ii) the foregoing significantly diminished the approval and commercialization prospects for ThermoDox; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.
On July 13, 2020, Celsion announced that "it ha[d] received a recommendation from the independent [DMC] to consider stopping the global Phase III OPTIMA Study of ThermoDox® in combination with [RFA] for the treatment of [HCC], or primary liver cancer." According to the Company, "[t]he recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020," which "found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903."
On this news, Celsion's stock price fell $2.29 per share, or 63.97%, to close at $1.29 per share on July 13, 2020.
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.
SOURCE: Pomerantz LLP