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Verastem Inc (NASDAQ:VSTM) Blood Cancer Drug Meets Primary Endpoints

Verastem Inc. (NASDAQ:VSTM)

Verastem Inc (NASDAQ:VSTM)

Shares of Verastem Inc (NASDAQ:VSTM) rallied 28.13% after the company announced positive Phase 3 trial results for its blood cancer drug. The stock had initially jumped 50.3% after the company announced that Duvelisb met its primary endpoints in the late stage trial.

Duvelisib is an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma under trial for the treatment of hematologic cancers such as indolent non-Hodgkin lymphoma (iNHL) and other T cell lymphomas. Verastem Inc (NASDAQ:VSTM) tested the drug on 319 patients suffering from chronic lympocytic leukemia or small lymphocytic lymphoma

In addition to the positive Phase 2 trial results, the drug is also supported by compelling Phase 1 results that demonstrated a 50% investigator-assessed response rate.

VSTM Investor Reaction

The positive clinical trial results saw the stock gap higher to highs of $5.50 a share before retreating to end the day at $4.92 a share. The stock has already broken key resistance levels of $4.00 and $4.50 a share, further affirming a bullish run that began in July. Verastem Inc (NASDAQ:VSTM) shares are already up by more than 300% for the year.

Verastem Inc. (NASDAQ:VSTM) is currently trading near all-time highs. Renewed investor interest on the stock comes on the biopharmaceutical company saying that Duvelisib reduced the risk of disease progression or death by 48%, compared to standard care Arzerra.

Fuelling investor interests are reports that the Duvelisib, if approved, could generate as much as $400 million in sales for the company. Equity firms have already taken note of Duvelisib potential, with analysts at Oppenheimer initiating coverage of the stock with a ‘buy’ rating.

One month VSTM stock price chart

Regulatory Push

Verastem Inc (NASDAQ:VSTM) plans to share the clinical data with the U.S Food and Drug Administration (FDA) with the goal of filling a New Drug Application (NDA). The filling is to be supported by results from DUO study and CLL/SLL and the DYNAMO study – all of which achieved primary endpoints. The company has also confirmed plans to file for a marketing application for the drug.

Verastem Inc (NASDAQ:VSTM) is also planning to expand Duvelisb development program with a view of carrying out trials on its ability to treat Peripheral T-Cell Lymphoma. Duvelisib has already been granted Fast Track Designation by the FDA for the treatment of PTCL.

“Expansion of the Duvelisib clinical development program, and the accompanying receipt of Fast Track designation from the FDA are important steps in Verastem’s strategy to efficiently develop the potential of duvelisib in additional cancers such as T-cell malignancies,” said Robert Forrester, President and Chief Executive Officer of Verastem Inc (NASDAQ:VSTM).

Board Appointment

Following the positive Duvelisib trial results, Verastem Inc. (NASDAQ:VSTM) has confirmed the appointment of Brian Stuglik to the board of directors. He joins the company with over 30 years’ experience in Pharmaceutical and oncology commercialization.

“Brian Stuglik is an accomplished executive with significant oncology commercialization expertise who can bring immediate value to Verastem as we now move towards commercializing duvelisib,” said Mr. Forrester.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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Monica has an undergraduate degree in Accounting and an MBA she earned - with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

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