Verastem Inc (NASDAQ: VSTM) is having an overwhelmingly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced positive trial data from its Phase 3 DUO clinical trial over the weekend. Of course, this led to excitement among investors, sending the stock screaming for the top. Today, we’ll talk about what we saw in the press release, how the stock reacted to the news, and what we’ll be watching with regard to VSTM ahead.
VSTM Gains On Phase 3 Update
As mentioned above, Verastem is having an overwhelmingly strong start to the trading session this morning after announcing the presentation of results from a Phase 3 DUO study. The study was designed to evaluate the efficacy and safety of duvelisib as a treatment for relapsed or refractory chronic lymphocytic leukemia.
In the press release, VSTM announced that it would be presenting the data at the American Society of Hematology 2017 Annual Meeting. The meeting will be held from December 9th through December 12th in Atlanta. In a statement, Ian Flinn, MD, PhD, Director of the Blood Research Program at Sarah Cannon Research Institute and Lead Investigator of the VSTM clinical trail, had the following to offer:
“In the Phase 3 DUO study, oral duvelisib monotherapy achieved a statistically significant improvement in Progression-Free Survival versus the approved standard of care treatment ofatumumab, along with a well characterized and manageable safety profile, in patients with previously treated CLL/SLL… Similar PFS advantages were also observed across all analyzed patient subgroups, including patients with `7p deletion, a genotype that historically correlates with poorer clinical outcomes. Duvelisib also achieved a statistically significant improvement in Overall Response Rate and significantly reduced lymph node burden in the vast majority of patients. These data are encouraging for patients with CLL/SLL who progress or relapse following initial treatment.”
The above statement was followed up by Diep Le, MD, PhD, CMO at VSTM. Here’s what he had to offer:
“CLL/SLL mostly affects elderly patients and many are unable or unwilling to be hospitalized or come into the clinic for frequent IV infusions. The CLL/SLL treatment landscape therefore is moving away from chemotherapies and toward more targeted, preferably oral regimens… While patients are living longer many will be intolerant to, or relapse following, their initial therapy emphasizing the need for new options. Oral duvelisib is the first Pl3K inhibitor to show efficacy as an oral monotherapy in a randomized Phase 3 study in patients with relapsed or refractory CLL/SLL and may offer an appealing alternative for patients who have progressed or relapsed. We remain on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the first quarter of 2018 requesting full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL).”
How The Stock Is Reacting To The News
As investors, one of the first things that we learn is that the news moves the market. Considering the overwhelmingly positive news released by Verastem, it’s no surprise that we’re seeing strong movement in the market. At the moment (8:03), VSTM is trading at $5.00 per share after a gain of $1.67 per share (15.47%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on VSTM. In particular, we’re interested in the next steps surrounding bringing duvelisib to market. Nonetheless, we’ll continue to follow the story close and bring the news to you as it breaks!
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