The Way Forward For Verastem


 
 
01:04 12/11/2017

Needham, Massachusetts based Verastem, Inc.VSTM  has a choppy daily chart that would turn away momentum players. However a glance at the weekly chart would be more enticing for long term traders as this stock is still in uptrend mode. The company is focused on discovering and developing drugs to improve the survival and quality of life of cancer patients.

Verastem today announced the presentation of the results from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) at the American Society of Hematology (ASH) 2017 Annual Meeting held December 9-12, 2017 in Atlanta. Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma which is currently being developed for the treatment of CLL/SLL and follicular lymphoma (FL). In addition, duvelisib is being studied in other hematologic malignancies including peripheral T cell lymphoma (PTCL).

In late October the company announced that a meeting was held with the U.S. Food and Drug Administration (FDA) regarding the regulatory path for duvelisib, the Company’s first-in-class, oral, monotherapy, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, which is being developed for the treatment of patients with lymphoid malignancies.

Based on the meeting with, and written feedback from the FDA, Verastem intends to submit a New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL). The Company expects to submit the duvelisib NDA during the first quarter of 2018.

Duvelisib is a first-in-class investigational, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.


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