According to the law firm press release, this case alleges that the defendants made materially false or misleading statements with respect to the safety and efficacy of the Company’s drug Macrilen™. A November 6, 2014, press release by the Company brought these facts to light by announcing that the FDA had issued a Complete Response Letter refusing to approve the Company’s New Drug Application because of “the lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD.

An amended Complaint was filed on April 10, 2015.

On September 16, 2015, the Court granted Defendant's Motion to Dismiss with leave to amend. Plaintiffs filed an amended Complaint on October 14. On November 11, Defendants filed a Motion to Dismiss. On March 2, 2016, the Court issued an Order, granting in part and denying in part, Defendants' Motion to Dismiss. Several Individual Defendants were dismissed from the case.

On May 8, 2017, Lead Plaintiffs filed a Motion for Class Certification. On February 28, 2018, the Court issued an Order granting Lead Plaintiffs' Motion. Defendant filed a Notice appealing the class certification Order on June 20, 2018. On May 30, 2019, the Court of Appeals affirmed the District Court's Order granting class certification.