Case Page


Case Status:    ONGOING    
On or around 10/28/2016 (Ongoing date of last review)

Filing Date: July 15, 2016

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On June 8, 2016, after the market closed, Insmed announced that it had withdrawn its MAA from the EMA for Arikayce for the treatment of NTM lung disease.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.


Sector: Healthcare
Industry: Biotechnology & Drugs
Headquarters: United States


Ticker Symbol: INSM
Company Market: NASDAQ
Market Status: Public (Listed)

About the Company & Securities Data

"Company" information provides the industry and sector classification and headquarters state for the primary company-defendant in the litigation. In general, "Securities" information provides the ticker symbol, market, and market status for the underlying securities at issue in the litigation.

In most cases, the primary company-defendant actually issued the securities that are the subject of the litigation, and the securities information and company information relate to the same entity. In a small subset of cases, however, the primary company-defendant is not the issuer (for example, cases against third party brokers/dealers), and the securities information and company information do not relate to the same entity.
COURT: D. New Jersey
DOCKET #: 16-CV-04323
JUDGE: Hon. Freda L. Wolfson
DATE FILED: 07/15/2016
CLASS PERIOD END: 06/08/2016
  1. Bronstein, Gewirtz & Grossman, LLC (New York)
    60 East 42nd Street - Suite 4600, Bronstein, Gewirtz & Grossman, LLC (New York), NY 10165
    212.697.6484 212.697.7296 ·
  2. Lite DePalma Greenberg, LLC (Newark)
    Two Gateway Center - 12th Floor, Lite DePalma Greenberg, LLC (Newark), NJ 07102-5003
    973.623.3000 ·
  3. Pomerantz LLP (New York)
    600 Third Avenue, Pomerantz LLP (New York), NY 10016
    212.661.1100 212.661.8665 ·
No Document Title Filing Date