What happened
Shares of U.K.-based biotech Roivant Sciences (ROIV +2.19%) were up by 10.2% on heavy volume as of 10:21 a.m. ET Thursday. The drugmaker's stock is jumping in response to positive long-term data for its midstage ulcerative colitis therapy, RVT-3101.
RVT-3101 belongs to a novel class of biologic therapies known as anti-TL1A antibodies that have shown tremendous promise in the treatment of autoimmune disorders like ulcerative colitis and Crohn's disease (two common forms of inflammatory bowel disease). The therapy was originally part of Pfizer's (PFE +1.25%) homegrown portfolio. However, Pfizer offloaded a portion of RVT-3101's commercial rights to Roivant last December.
So what
Ahead of the opening bell, Roivant announced that patients treated with the expected phase 3 dose of RVT-3101 in this large phase 2b trial exhibited a 36% clinical remission rate at week 56 (up from 29% at week 14). Even better, patients in the biomarker-positive population of the study exhibited a 43% clinical remission rate at week 56.
NASDAQ: ROIV
Key Data Points
With other anti-TL1A antibodies further along in development, Roivant appears to be targeting second-line patients who express known biomarkers for ulcerative colitis as the drug's main focal group. If approved in this setting, RVT-3101 could top $2 billion in annual sales. That's an enormous sum for a biotech with a $7.9 billion market cap at the time of this writing.
Now what
Is Roivant's stock a buy on this positive clinical update? I think so. Based on the data published so far, the biotech seems to be developing a curve-bending drug for ulcerative colitis. That's a big deal in the world of biopharma. Inflammatory bowel disease, after all, represents a $15 billion drug market annually.
