Publicly available records indicate that a class action lawsuit has been filed on behalf of investors in Edge Therapeutics (NASDAQ:EDGE) in connection to alleged violations of securities laws by EDGE. Fitapelli Kurta is interested in hearing from investors who have complaints regarding investments made in Therapeutics between December 29, 2017 and March 27, 2018.
The class action complaint specifically alleges that during the period in question, EDGE might have provided false and/or misleading material information, and/or failed to disclose adverse material information to the public, namely: that EG-1962, the company’s lead product candidate, was likely to fail its futility analysis in the NEWTON 2 study; and that consequently the company’s financial statements, as well as its statements to the public about its business, operations and prospects during the relevant period, were false and misleading. The company disclosed on March 28, 2018, that “a pre-specified interim analysis on data from the Day 90 visit of the first 210 subjects randomized and treated in the Phase 3 NEWTON 2 study of EG-1962 demonstrated a low probability of achieving a statistically-significant difference compared to the standard of care in the study’s primary endpoint, if the study is fully enrolled.” The company’s Data Monitoring Committee had recommended, in connection to this, that based on its conclusion that the study was unlikely to meet its primary endpoint, the study should be halted. The company announced that as a result of this recommendation, it had decided to end the Phase 3 NEWTON 2 study. After this news was announced, the company’s stock declined about 92%, or $14.28/share, closing at $1.31/share on that day. The complaint alleges that when true facts came to light, investors suffered losses.
According to the company’s website, Edge Therapeutics is a biotechnology company involved in the discovery, development and commercialization of new, hospital-based therapies for the treatment of “acute, life-threatening neurological and other conditions.” The company’s description states that its product candidates use its “proprietary, programmable, biodegradable polymer-based development platform (the Precisa™ development platform), and a novel delivery mechanism that seeks to enable targeted and sustained drug exposure and avoid the dose-limiting side effects associated with the current standard of care systemic delivery.” The company also states, in this description, its belief that its lead product candidate EG-1962 “fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm.” The company trades on the Nasdaq exchange under the symbol EDGE.