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May 12, 2021 - The court preliminarily approved the settlement.
April 30, 2021 - A stipulation of settlement was filed by the parties.
November 25, 2020 - The court denied the defendants' motion to dismiss.
April 23, 2020 - A motion to dismiss the amended complaint was filed.
March 9, 2020 - An amended complaint was filed.
October 23, 2019 - An investor in shares of Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) filed a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania over alleged violations of Federal Securities Laws by Zynerba Pharmaceuticals, Inc. in connection with certain allegedly false and misleading statements made between March 11, 2019, and September 17, 2019.
Devon, PA based Zynerba Pharmaceuticals, Inc. operates as a clinical stage specialty pharmaceutical company.
In April 2018, Zynerba Pharmaceuticals, Inc initiated the Phase 2 BELIEVE 1 (Open Label Study to Assess the Safety and Efficacy of Zygel Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy) clinical trial (“BELIEVE 1 Trial”), a six-month open label multi-dose clinical trial designed to evaluate the efficacy and safety of Zygel in children and adolescents (ages three to seventeen years) with DEE as classified by the International League Against Epilepsy (“ILAE”).
On September 18, 2019, during pre-market hours, Zynerba Pharmaceuticals, Inc announced results from the BELIEVE 1 Trial evaluating topical gel Zygel in children and adolescents with DEE. While Zynerba Pharmaceuticals, Inc asserted that Zygel was well-tolerated in the announcement, it also disclosed that, among patients enrolled in the BELIEVE 1 Trial, the rate of treatment emergent adverse events (“TEAEs”) was 96%, the rate of treatment related adverse events (“TRAEs”) was 60%, and there were ten patients who reported serious adverse events (“SAEs”), of which, “two SAEs (lower respiratory tract infection and status epilepticus) were determined to be possibly related to treatment.” Shares of Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) declined to as low as $6.83 per share on October 2, 2019.
According to the complaint the plaintiff alleges on behalf of purchasers of Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) common shares between March 11, 2019, and September 17, 2019, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that between March 11, 2019, and September 17, 2019, the defendants made false and/or misleading statements and/or failed to disclose that Zygel was proving unsafe and not well-tolerated in the BELIEVE 1 Trial, that the foregoing created a foreseeable, heightened risk that Zynerba would fail to secure the necessary regulatory approvals for commercializing Zygel for the treatment of DEE in children and adolescents, and that as a result, the Company’s public statements were materially false and misleading at all relevant times.