ABVX Stock Rockets 28% After Abivax Eases Drug Safety Concerns With Fresh Clinical Data

• Rates of malignancies and certain skin cancers in the trial remained in line with what is typically seen in people living with ulcerative colitis, the company said. 
• This helps resolve certain earlier concerns identified in the first part of the trial, wherein there was a numerical increase in malignancies. 
• The company confirmed plans to submit a new drug application to the U.S. Food and Drug Administration in the fourth quarter of this year.

Abivax (ABVX) stock jumped 28% in after-hours trading on Monday after the company released encouraging late-stage results for its experimental drug, obefazimod, in patients with ulcerative colitis, and eased previous safety concerns about higher cancer incidence.

Encouraging Results For Hard-To-Treat Patients

The new data came from the second part of a large maintenance study. It focused on patients who did not respond well to the initial eight weeks of treatment or who had relapsed later. Many of these patients still showed meaningful improvement when they continued or increased their dose of obefazimod.

In one key group treated with the higher dose, more than one-third achieved clinical remission, and similar rates saw healing in the lining of the colon at week 44, the company said. The drug also helped recapture disease control in patients who had relapsed, supporting a flexible dosing approach, it added.

Safety Data Eases Earlier Concerns

The results also expanded the long-term safety database. In part 2 of the maintenance study, four cases of non-melanoma skin cancer (NMSC) were reported — two in each dose arm. All four occurred in patients with established risk factors, including older age, prior thiopurine use, or history of skin cancer. Two additional non-NMSC malignancies were seen in the 50 mg group and deemed unrelated to obefazimod, the company said. Overall malignancy rates remained consistent with background rates in ulcerative colitis patients, it added.

This helps resolve certain earlier concerns identified in the first part of the trial, wherein there was a numerical increase in malignancies, particularly non-melanoma skin cancers (NMSC) in the higher 50 mg dose group. Even though Abivax said most of these cases occurred in older patients who already had risk factors and that the rates were consistent with what is normally seen in ulcerative colitis patients, the market reacted negatively.

ABVX Advances Toward Regulatory Filing

Abivax said the findings strengthen the overall case for obefazimod and reinforce its favorable benefit-risk profile. The company confirmed plans to submit a new drug application to the U.S. Food and Drug Administration in the fourth quarter of this year.

Chief Executive Marc de Garidel called the results an important milestone that supports obefazimod’s potential to help a broad range of patients with the condition.

How Did ABVX Retail Traders React?

On Stocktwits, retail sentiment around ABVX rose from ‘neutral’ to ‘bullish’ over the past 24 hours, while message volume jumped from ‘low’ to ‘normal’ levels.

A Stocktwits user expressed optimism for a major rally on Tuesday, driving the stock up to $150 from Monday’s closing price of $96.15.

Another voiced hopes for a merger or acquisition for the company following the trial results.

A third user voiced hopes for Eli Lilly and Company purchasing Abivax.

ABVX stock has lost 29% year-to-date. 

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