According to the law firm press release, NewLink Genetics Corporation ("NewLink"), a biopharmaceutical company, focuses on discovering, developing, and commercializing immunotherapeutic products to enhance treatment options for patients with cancer. Among the Company’s product candidates is algenpantucel-L, a pancreatic cancer treatment.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the Company’s algenpantucel-L treatment was ineffective and potentially harmful to patients; and (ii) as a result of the foregoing, NewLink’s public statements were materially false and misleading at all relevant times.
On May 9, 2016, post-market, NewLink announced that algenpantucel-L did not meet the main goal in the Company’s Phase 3 IMPRESS study. Patients treated with algenpantucel-L lived for a median of 27.3 months in NewLink's Phase 3 trial, compared to median survival of 30.4 months for patients treated with standard therapy, suggesting that patients were actually harmed by NewLink's treatment.
On this news, NewLink's stock price fell $5.05, or 30.61%, to close at $11.45 on May 10, 2016.
On August 16, 2016, the Court appointed Lead Plaintiff and Counsel. Lead Plaintiffs filed an amended Complaint on October 31. A corrected version of this Complaint was filed on November 10.
Defendants filed a Motion to Dismiss the amended Complaint on July 14, 2017. On March 29, 2018, the Court issued an Order granting Defendants' Motion to Dismiss. Plaintiffs were given leave to file an amended Complaint. Lead Plaintiffs filed a second amended Complaint on May 4. Defendants filed a Motion to Dismiss the second amended Complaint on July 31. On February 13, 2019, the Court issued an Order granting Defendants' Motion to Dismiss the second amended Complaint. Lead Plaintiffs filed a Notice appealing the Dismissal Order on March 14, 2019. On July 13, 2020, the Court of Appeals affirmed in part and reversed in part the District Court's dismissal Order. The case was remanded for further proceedings.
On February 1, 2021, the parties entered into a Stipulation and Agreement of Settlement. The Court issued an Order denying preliminary approval of the Settlement on February 25. Parties were directed to re-submit the motion with revisions. On March 22, the parties entered into an amended Stipulation and Agreement of Settlement. The Court issued an Order granting preliminary approval of the Settlement on April 2. On September 22, the Court granted final approval of the Settlement and entered Final Judgment. The Court approved the Settlement's distribution on November 23.