According to the law firm press release, Geron is a clinical stage biopharmaceutical company developing first-in-class therapies for cancer. The Company’s sole product candidate, imetelstat, is designed to inhibit cancer cell replication in hematologic myeloid malignancies such as myelofibrosis or acute myelogenous leukemia. The Complaint alleges that throughout the Class Period defendants misrepresented or failed to disclose that: (1) persistent low-grade liver function test (LFT) abnormalities had been observed in the Phase 2 study of imetelstat in essential thrombocythemia (ET) or polycythemia vera (PV) patients; (2) there was a potential risk of chronic liver injury following long-term exposure to imetelstat; and (3), as a result of the foregoing, defendants’ positive statements about the Company and the prospects for imetelstat lacked any reasonable basis and/or were materially false and misleading at all relevant times.
On March 12, 2014, Geron disclosed that it had received verbal notice from the U.S. Food and Drug Administration that Geron’s Investigational New Drug application for imetelstat has been placed on full clinical hold – an order to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial – affecting all ongoing company-sponsored clinical trials, and that the FDA expressed concern about whether the LFT abnormalities were reversible. As a result, Geron informed investors that the clinical hold would affect the remaining eight patients in the Company’s Phase 2 study in ET/PV and the remaining two patients in the company’s Phase 2 study in multiple myeloma. Also, the Company indicated that a planned Phase 2 clinical trial in myelofibrosis would likely be delayed due to the clinical hold.
On June 30, 2014, the Court issued an Order consolidating related actions, appointing lead plaintiff, and approving the selection of lead counsel. Lead plaintiff filed a consolidated and amended complaint on September 19.
The parties filed a Stipulation of Settlement on March 2, 2017. This Settlement was preliminarily approved on April 10. On July 21, 2017, the Court granted final approval of the Settlement and dismissed this case.