According to the Complaint, Nektar Therapeutics is a biopharmaceutical company that develops medicines in areas of high unmet medical need, including therapies for cancer, autoimmune disease, and chronic pain. Nektar’s lead immuno-oncology candidate is NKTR-214, also known as bempegaldesleukin or bempeg; it is a biologic substance developed to stimulate proliferation and growth of tumor-killing immune cells in the tumor-micro-environment. In the PIVOT-02 clinical study, the Company evaluates the benefit, safety, and tolerability of combining NKTR-214 with Opdivo, an antibody, in collaboration with Bristol-Meyers Squibb Company.
The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the Complaint alleges Defendants failed to disclose to investors: (1) that the Company did not comply with current good manufacturing practices; (2) that, as a result, batches of NKTR-214 were not produced consistently and differed meaningfully; (3) that clinical results from PIVOT-02 differed based on the batch of NKTR-214 used in the study; (4) that, as a result, the PIVOT-02 study did not produce statistically significant results to support a finding of clinical benefit; and (6) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
On November 15, 2019, the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on January 24, 2020. Defendants filed Motions to Dismiss the amended Complaint on April 10. On January 26, 2021, the Court issued an Order granting Defendants' Motions to Dismiss. Plaintiffs were given leave to amend the Complaint. On March 2, Plaintiffs voluntarily dismissed the case.