Shares of Abivax SA (ABVX) are trading at an all-time high of $80, thanks to the recently announced encouraging clinical trial results for its experimental ulcerative colitis drug, Obefazimod.
Obefazimod is being evaluated in a pivotal global phase III clinical trial program in moderately to severely active ulcerative colitis, dubbed ABTECT.
The ABTECT program consists of two 8-week induction trials, dubbed ABTECT-1 and ABTECT-2, and a 44-week maintenance trial. In the trials, the efficacy and safety of 50mg and 25mg doses of Obefazimod, administered once daily (QD), are compared to those of the placebo.
The company reported positive topline results from its Phase 3 ABTECT-1 and ABTECT-2 induction trials on July 22, 2025, driving the stock up from $10 to a high of $71 - a remarkable 610% increase.
Ulcerative colitis (UC) is a type of Inflammatory bowel disease (IBD), driven by a dysregulated immune system and genetic factors. There are several approved drugs to treat UC, but their efficacy in achieving full remission (i.e., no or minimal signs of disease activity) is said to be limited.
The company expects to report topline results from the ABTECT maintenance trial in Q2 2026, which are intended to support regulatory filings globally.
If all goes well as planned, Abivax intends to submit a New Drug Application to the FDA and a Marketing Authorization Application to the European Medicines Agency in the second half of 2026.
When we alerted readers to ABVX on July 1, 2025, it was trading at $7.83. The stock hit an all-time high of $81 in early trading today, reflecting a gain of over 900% in just under two months. Were you on board?
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