Verastem Inc. (NASDAQ: VSTM) made perhaps making the biggest gain in the market Wednesday after the company announced positive late-stage results from its study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). This stock has been on a roller-coaster in just 2017 alone, with the stock up over 240% excluding this move, but the stock is still well removed from its highs of two years ago.
Wednesday seems to be a relatively strong day for biopharma stocks, with the likes of Sarepta seeing a strong gain on the day as well.
As for Verastem, its first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, duvelisib, achieved its primary endpoint in the study. In fact, it showed superiority over ofatumamab, an approved standard of care treatment for patients with CLL/SLL.
Specifically, duvelisib achieved a statistically significant improvement in median progression free survival (PFS) of 13.3 months, shattering expectations, compared to 9.9 months for ofatumumab.
Looking ahead, the firm plans to share these clinical data with the U.S. Food and Drug Administration (FDA), intent on filing a New Drug Application (NDA) with the FDA during the first half of 2018.
Ian Flinn, M.D., Ph.D, director of the Blood Cancer Research Program at Sarah Cannon Research Institute and the lead investigator on the DUO study, commented:
Although the treatment of CLL/SLL has advanced in recent years, there remains a substantial unmet need with many patients progressing or relapsing following the available therapies. These positive results from the randomized DUO study demonstrate that duvelisib prolongs progression-free survival (PFS) with a manageable safety profile in patients with relapsed or refractory CLL/SLL, including in high risk patients with the 17p deletion. For our patients with CLL/SLL, and for the physicians who treat them, a convenient, oral monotherapy that is taken at home would be a valuable addition to the treatment landscape.
Shares of Verastem were last seen up about 28% at $4.94, with a consensus analyst price target of $4.63 and a 52-week range of $1.05 to $5.55.