Blog Exposure - Verastem Reported Submission of NDA For Duvelisib for Treatment of Patients with Relapsed or Refractory CLL/SLL and Follicular Lymphoma
Stock Monitor: Cambrex Post Earnings Reporting
LONDON, UK / ACCESSWIRE / February 09, 2018 / Active-Investors.com has just released a free research report on Verastem, Inc. (VSTM). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=VSTM as the Company's latest news hit the wire. On February 07, 2018, the Needham based clinical stage biopharmaceutical Company announced that it has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) seeking full approval for its lead product candidate duvelisib, for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The Company expects a potential FDA approval in early 2019. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Verastem most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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NDA is Supported by Clinical Data from Phase-3 DUO™ Study and Phase-2 DYNAMO™ Study
In September 2017, the Company reported positive top-line results from the Phase-3, randomized, open-label DUO study evaluating the efficacy and safety of duvelisib, along with a consistent and manageable safety profile, in patients with relapsed or refractory CLL/SLL. In the DUO study, with the primary endpoint of progression free survival (PFS) as determined by Independent Review Committee, oral duvelisib monotherapy showed superiority over ofatumumab, an approved standard of care treatment for patients with CLL/SLL.
In the Phase 2 DYNAMO study, duvelisib achieved meaningful clinical activity in patients diagnosed with FL, SLL or marginal zone lymphoma (MZL) whose disease is refractory to rituximab and to a chemotherapy regimen or radioimmunotherapy, which included robust and durable responses, and a manageable safety profile.
Duvelisib Received Fast Track Designation for Patients with CLL or PTCL
Duvelisib has received Fast Track Designation from the FDA for patients with CLL or peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. Additionally, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL, and FL.
About Duvelisib
Duvelisib is a potent and selective oral small molecule inhibitor of PI3K-δ (delta) and PI3K-γ (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-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment. Duvelisib is Verastem's lead drug candidate.
About Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
CLL is a typically slow-growing cancer which begins in lymphocytes in the bone marrow and extends into the blood. It can also spread to lymph nodes and organs such as the liver and spleen. CLL develops when too many abnormal lymphocytes grow, crowding out normal blood cells and making it difficult for the body to fight infection.
SLL is a cancer that affects a type of white blood cell called a lymphocyte, which helps your body fight infection. These cells may be present in lymph nodes and lymphoid tissue such as the spleen and the tonsils.
About Follicular Lymphoma
FL is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for around 12% of all B-cell NHLs. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss.
About Verastem, Inc.
Founded in 2010, Verastem is a biopharmaceutical company focused on discovering and developing drugs to improve outcomes for patients with cancer. The Company's product candidates seek to treat cancer by targeting malignant cells both directly and through modulation of the tumor microenvironment.
Stock Performance Snapshot
February 08, 2018 - At Thursday's closing bell, Verastem's stock fell 3.22%, ending the trading session at $3.31.
Volume traded for the day: 480.60 thousand shares.
Stock performance in the last month – up 12.59%; past twelve-month period – up 175.83%; and year-to-date - up 7.82%
After yesterday's close, Verastem's market cap was at $145.14 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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