Shares of the biopharmaceutical company Verastem Inc. (NASDAQ:VSTM) were on the rise on Monday after the company announced that the United States Food and Drug Administration (FDA) had accepted their New Drug Application (NDA) for priority review.
The drug, duvelisib, is meant to help with the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and the treatment of relapsed or refractory follicular lymphoma (FL).
>>>Sonoma Pharmaceuticals Gets FDA Approval – Shares Soar
Being granted priority review by the FDA means that duvelisib, if it is approved, will provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a severe condition.
In addition to the acceptance of Verastem’s NDA, the FDA also gave duvelisib “orphan drug” designation. This designation identifies a drug that is meant to provide safe and effective treatment, diagnosis or prevention of diseases and disorders that usually affect less than 200,000 people in the US.
>>>EyeGate Pharmaceuticals Stock Up Nearly 25% – April 6
According to CEO and President of Verastem Inc, Robert Forrester: “as an orally administered therapy, [they] believe duvelisib will provide an important treatment option for patients with CLL/SLL and FL, and for the physicians who treat them” and the FDA approval “marks another important milestone for Verastem.”
Verastem Inc is continuing their “commercial preparations for duvelisib to execute the launch promptly in the U.S.,” – if it is approved.
The FDA must complete their review of the duvelisib application by the target action date of October 5, 2018.
Shares of Verastem went up by 10.81% and closed at $3.28 USD with a high of $3.44, which is a significant improvement compared to the company’s $2.96 closing share value, on Friday.
Monday’s closing share value was also the highest closing price the company has had since mid-March 2018.
Featured Image: Facebook
