May 27, 2021 - An amended complaint was filed.

October 29, 2020 - An investor in shares of Celsion Corporation (NASDAQ: CLSN) filed a lawsuit in the U.S. District Court for the District of New Jersey over alleged violations of Federal Securities Laws by Celsion Corporation in connection with certain allegedly false and misleading statements made between November 2, 2015 and July 10, 2020.

Lawrenceville, NJ based Celsion Corporation, an integrated development clinical stage oncology drug company, 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 Corporation 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 ).

On July 13, 2020, Celsion Corporation 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. Shares of Celsion Corporation (NASDAQ: CLSN) declined from $6.5 per share on June 17, 2020 to as low $0.47 per share on October 30, 2020.

According to the complaint the plaintiff alleges on behalf of purchasers of Celsion Corporation (NASDAQ: CLSN) common shares between November 2, 2015 and July 10, 2020, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between November 2, 2015 and July 10, 2020, the Defendants made false and/or misleading statements and/or failed to disclose that Defendants had significantly overstated the efficacy of ThermoDox, that the foregoing significantly diminished the approval and commercialization prospects for ThermoDox, and that as a result, the Company's public statements were materially false and misleading at all relevant times.