Insmed, Inc. (INSM) Misled Shareholders According to a Recently Filed Class Action
Robbins Arroyo LLP announces that a class action complaint was filed against Insmed, Inc. (NASDAQGS: INSM) in the U.S. District Court for the District of New Jersey. The complaint is brought on behalf of all purchasers of Insmed securities between March 18, 2013 and June 8, 2016, for alleged violations of the Securities Exchange Act of 1934 by Insmed’s officers and directors. Insmed, a biopharmaceutical company, focuses on the development and commercialization of inhaled therapies for patients with serious lung diseases. The company’s lead product candidate is known as Arikayce, or liposomal amikacin, for treatment of nontuberculous mycobacteria (“NTM”) lung disease.
Insmed Accused of Misleading Investors About Its Lead Product Candidate
According to the complaint, throughout the class period, Insmed submitted several filings with the U.S. Securities and Exchange Commission touting positive financial results and stating that the financial information was accurate and disclosed any material changes to the company’s internal control over financial reporting. In fact, with regard to its clinical trials, Insmed officials spoke with confidence, stating, “Collectively, these data sets bring us closer to our goal to commercialize a potentially life-saving treatment for patients suffering from these orphan lung diseases.” In addition, Insmed officials seemed optimistic about Arikayce’s potential for commercialization, stating, “We continue to advance our regulatory filing and our preparations for commercialization in Europe.”
However, the complaint alleges that Insmed officials failed to disclose that: (i) the data on which Insmed’s European marketing authorization application (“MAA”) for Arikayce relied was not likely to support approval by the European Medicines Agency (“EMA”) for the treatment of NTM lung disease; (ii) Arikayce’s approval by the EMA for treatment of NTM lung disease and subsequent commercialization in Europe were thus less likely and/or imminent than Insmed had led investors to believe; and (iii) as a result of the foregoing, Insmed’s public statements were materially false and misleading at all relevant times. On June 8, 2016, Insmed announced that it had withdrawn its MAA from the EMA for Arikayce for the treatment of NTM lung disease. The company revealed that the Committee for Medicinal Products for Human Use indicated that the phase 2 study did not provide a sufficient amount of evidence to support an approval. On this news, Insmed stock fell $0.99 per share, or 8.24%, to close at $11.02 per share on June 9, 2016.
Insmed Shareholders Have Legal Options
Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.