According to the law firm press release, Eagle Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of injectable products, primarily in the critical care and oncology areas. Eagle Pharmaceuticals is headquartered in Woodcliff Lake, New Jersey.
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: the Company made misrepresentations about the FDA approval process for its new anticoagulant drug, KANGIO™.
On February 25, 2016, Eagle Pharmaceutical’s CEO stated, regarding the pending New Drug Application for KANGIO™, “We have been interacting with FDA and we are preparing for launch, everything seems to be on track for a March 19 approval, and we anticipate shipping in late Q1 or early Q2.”
However, on March 18, 2016, Eagle Pharmaceuticals announced that it had received a Complete Response Letter from the FDA stating that the FDA “cannot approve the application in its present form and requested additional information” regarding the substances used in KANGIO™.
On this news, Eagle Pharmaceuticals stock fell $10.18, or 18.96%, to close at $43.50 on March 18, 2016.
On September 9, 2016, the Court appointed Lead Plaintiff and Counsel. Lead Plaintiffs filed an amended complaint on October 31.