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.