Lead Plaintiff Deadline: 12/28/2020
SUMMARY OF CASE:
A securities class action has been filed against Celsion Corporation (CLSN) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Celsion securities between November 2, 2015 through July 10, 2020. This case has been filed in the USDC – NJ.
Celsion was founded in 1982 and is headquartered in Lawrenceville, New Jersey. 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 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) 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.