Verastem Inc (NASDAQ:VSTM) Is A Biotech Winner For Our Readers

On August 31, we highlighted Verastem Inc (NASDAQ:VSTM) as a biotech catalyst play in this piece, titled Here’s Why Verastem Could Soar Today.Our thesis was rooted in the fact that the company had put out a quiet notice a month or so before our coverage suggesting it was set to report data from a key clinical trial before the end of the summer and that, based on extrapolation from this "end of the summer" target, we should have seen the numbers on that day, August 31.As it turns out, we were a few days early without prediction. Not that that's a bad thing, of course – it gave our readers that little bit more time to pick up an exposure ahead of the event.The actual release date came in as September 6, with the company putting out data from the trailing question at the bell on Wednesday. The numbers came in as positive (the trial actually hit it out of the park) and Verastem has soared as a result.So what happened, and what's next?For those that missed our first coverage of this one, the trial in question was a phase 3 investigation into the safety and efficacy of an asset called Duvelisib, Which the company has been trying to develop as a potential treatment for patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL).The drug is designed to alter the macroenvironment in which tumors reside (and thrive) in order to make said environment hostile to cancer cells. In turn, this hostility is designed to prohibit proliferation and reproduction of the cells in question.And the data just told us that the drug works pretty much exactly as planned.According to the data that just hit press, the drug achieved a statistically significant improvement in median PFS of 13.3 months, compared to 9.9 months for ofatumumab (which is a standard of care therapy in the space and was used as a comparator arm in place of placebo). That's a close to 50% reduction in risk of progression or death in these patients – something that, at this late stage of disease progression, is relatively unheard of. The safety profile was relatively clean (as clean as can be expected with this sort of drug and in this sort of indication) and the company is set to submit for registration based on the data it collected as part of this trial.So that's what's next – a New Drug Application (NDA) submission to the FDA in the US, reportedly slated to take place during the first quarter of next year. Said application will also include data collected from a study in indolent non-Hodgkin’s lymphoma (iNHL), which also achieved its primary endpoint with an ORR of 46%, meaning there are two home run pivotal trials underpinning the company's approval company in very tough to treat cancers with large unmet needs.Analysts forecast that, at peak sales, this drug could bring in somewhere in the region of $400 million annually for Verastem. For reference, the company's value right now at a market capitalization of just $180 million and, when we highlighted it, was trading for a capitalization of just $144 million.So, all told, our readers have picked up a close to 30% depreciation on the back this news and the company looks set to continue to rise in value as the weekend approaches. We got a registration submission catalyst during the first quarter of next year, which, from where we're standing, looks like a shoo-in for approval, and some expanded indications that could build on the target population near term.We will probably see a raise ahead of any commercialization effort, so keep that in mind, but it's far from prohibitive to an exposure at this point.Check out our previous coverage of this one here. We will be updating our subscribers as soon as we know more. For the latest updates on VSTM, sign up below!Image courtesy of Erik Drost via FlickrDisclosure: We have no position in VSTM and have not been compensated for this article.