According to the law firm press release, Seattle Genetics develops and commercializes targeted therapies for the treatment of cancer worldwide. Among the Company’s products in development is SGN-CD33A (vadastuximab talirine). Throughout the Class Period, vadastuximab talirine was in clinical trials for various applications, including, in relevant part: (i) a Phase 1/2 trial in patients with acute myeloid leukemia (AML) as a pre-conditioning regimen prior to an allogenic stem cell transplant and as a maintenance therapy following transplant; (ii) a Phase 1 trial evaluating vadastuximab talirine monotherapy, including a subset of older AML patients in combination with hypomethylating agents; and (iii) a Phase 1 trial evaluating vadastuximab talirine combination treatment with 7+3 chemotherapy in newly diagnosed younger AML patients.
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, Defendants made false and/or misleading statements and/or failed to disclose that: (i) vadastuximab talirine presents a significant risk of fatal hepatotoxicity; (ii) as such, Seattle Genetics had overstated the viability of vadastuximab talirine as an AML treatment; and (iii) as a result of the foregoing, Seattle Genetics’ public statements were materially false and misleading at all relevant times.
On December 27, 2016, Seattle Genetics issued a press release and filed a Current Report on Form 8-K with the SEC, announcing that the U.S. Food and Drug Administration had placed a clinical hold or partial clinical hold on several early stage trials of the Company’s experimental cancer drug, vadastuximab talirine, to evaluate the potential risk of hepatotoxicity.
On this news, Seattle Genetics’ share price fell $9.50, or 15.36 %, to close at $52.36 on December 27, 2016.
A consolidated and amended complaint was filed on June 6, 2017.
On October 18, 2017, the Court issued an Order granting Defendants' Motion to Dismiss, with leave to amend. An amended complaint was filed on November 17.