According to the law firm press release, 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 Arikayce, or liposomal amikacin, for inhalation, a formulation of amikacin. Arikayce is in late-stage clinical development for treatment of nontuberculous mycobacteria (“NTM”) lung disease.
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: Defendants made false and/or misleading statements and/or 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 the 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On June 8, 2016, after the market closed, Insmed announced that it had withdrawn its MAA from the EMA for Arikayce for the treatment of NTM lung disease. The Company stated that “During the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, the CHMP indicated that the phase 2 study did not provide a sufficient amount of evidence to support an approval. Insmed intends to resubmit its MAA when clinical data from its ongoing global phase 3 study are available.”
On this news, Insmed’s share price fell $0.99, or 8.24%, to close at $11.02 on June 9, 2016.
On October 25, 2016, the Court appointed Lead Plaintiff and Counsel. Lead Plaintiff filed an amended complaint on December 15.