BioCentury
ARTICLE | Company News

Verastem gains on duvelisib Priority Review

April 9, 2018 8:33 PM UTC

Verastem Inc. (NASDAQ:VSTM) added $0.32 (11%) to $3.22 on Monday after it said FDA accepted and granted Priority Review to an NDA seeking full approval of duvelisib (IPI-145) to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The NDA is also seeking accelerated approval to treat relapsed or refractory follicular lymphoma (FL). Its PDUFA date is Oct. 5, 2018.

The company reported last September that duvelisib met the primary endpoint of improving median progression-free survival (PFS) vs. Arzerra ofatumumab in the Phase III DUO trial evaluating the candidate to treat relapsed or refractory CLL and SLL. Updated data, released in December, showed the duvelisib missed the secondary endpoint of improving overall survival (OS) vs. Arzerra (see BioCentury Extra, Dec. 11, 2017)...