Abivax SA (NASDAQ:ABVX) stock plunged in Tuesday premarket trading after investors focused on cancer cases reported in the Phase 3 maintenance study of its ulcerative colitis drug obefazimod, overshadowing otherwise strong efficacy results that met the trial’s primary and key secondary endpoints.
The company released data from its Phase 3 ABTECT maintenance trial evaluating obefazimod in patients with moderately to severely active ulcerative colitis.
The trial enrolled 580 individuals who had responded to induction treatment and evaluated once-daily oral obefazimod at 25 mg and 50 mg doses.
Obefazimod Meets Endpoints
At Week 44, both doses met the FDA primary endpoint of clinical remission, with remission rates of 50.8% and 51.3%, respectively, compared with 10.4% for placebo.
Placebo-adjusted remission rates reached 39.3% and 40.3%, both highly statistically significant.
Both doses of obefazimod met all key secondary endpoints, demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control.
Safety Concerns
While the company stated that obefazimod maintained a “favorable safety profile” with “no new safety signals,” several cancer malignancies were reported during the study.
In the 50 mg treatment arm, investigators recorded one case each of prostate cancer, breast cancer, and colonic dysplasia, equivalent to an incidence of 0.5% per event.
Non-melanoma skin cancers were also observed, including two cases each of basal cell carcinoma and squamous cell carcinoma in the 50 mg group, and one squamous cell carcinoma case in the 25 mg cohort, although one case of basal cell carcinoma was also reported in the placebo group.
Jefferies analysts said the reported cancer cases could weigh heavily on investor sentiment, even if they are ultimately determined to be unrelated to the drug. The firm warned that the safety signal may remain an overhang on the stock, particularly as Abivax lacks any major value-driving data readouts or catalysts over the next year, CNBC reported.
The company plans to submit a New Drug Application (NDA) to the FDA in the late fourth quarter of 2026, which could be a pivotal moment for its future.
Abivax Technical Analysis: Trend, Momentum And Key Levels
Currently, Abivax is trading at $90.07, significantly below its 20-day simple moving average (SMA) of $122.85, indicating a bearish trend.
The stock is 26.7% below this average, suggesting that it has been under pressure recently, and the momentum indicators reflect this sentiment.
The moving average convergence divergence (MACD) is currently above its signal line, indicating that downside pressure is easing, although the overall trend remains negative.
- Key Resistance: $98.50 — a nearby level where rebounds can stall.
- Key Support: $87.50 — a nearby level where buyers previously stepped in.
ABVX Stock Price Activity: Abivax shares were down 35.25% at $83.97 during premarket trading on Tuesday, according to Benzinga Pro data.
Photo via Shutterstock
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