Lawsuit Overview
March 22, 2018 - The complaint was not amended. The case was dismissed.
February 15, 2018 - The court granted the defendants' motion to dismiss. The plaintiffs were given leave to amend the complaint.
July 11, 2017 - A motion to dismiss the amended complaint was filed.
December 15, 2016 - An amended complaint was filed.
July 15, 2016 - An investor in shares of Insmed Incorporated (NASDAQ: INSM) filed a lawsuit in the U.S. District Court for the District of New Jersey over alleged violations of Federal Securities Laws by Insmed Incorporated in connection with certain allegedly false and misleading statements made between March 18, 2013 and June 8, 2016.
According to the complaint the plaintiff alleges on behalf of purchasers of Insmed Incorporated (NASDAQ: INSM) common shares between March 18, 2013 and June 8, 2016, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between March 18, 2013 and June 8, 2016 defendants issued allegedly false and misleading statements to investors and/or failed to disclose that the data on which Insmed Incorporated’s European marketing authorization application for Arikayce, Insmed Incorporated’s lead product candidate, relied was not likely to support approval by the European Medicines Agency (“EMA”) for the treatment of nontuberculous mycobacteria (“NTM”) lung disease, that Arikayce’s approval by the EMA for the treatment of NTM lung disease and subsequent commercialization in Europe were thus less likely and/or imminent than Insmed Incorporated had led investors to believe, and that as a result, defendants’ statements about Insmed Incorporated’s business, operations and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
On June 8, 2016, post-market, Insmed Incorporated announced that it had withdrawn a European marketing application submitted to the European Medicines Agency for its lung disease drug Arikayce. Insmed Incorporated stated that the marketing application was based on data from a mid-stage clinical study that didn't support enough evidence for an approval from the European Medicines Agency. Insmed Incorporated stated that the Company will resubmit the application when data is available from a later study.
Shares of Insmed Incorporated (NASDAQ: INSM) declined to $9.95 per share on June 9, 2016.