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PARIS - Abivax SA (Euronext Paris:FR0012333284 - ABVX / Nasdaq: ABVX), a clinical-stage biotechnology company with a market capitalization of $669 million, announced Tuesday that its oral ulcerative colitis treatment obefazimod met primary endpoints in two Phase 3 induction trials, demonstrating statistically significant clinical remission rates compared to placebo. The stock has shown strong momentum, gaining over 60% in the past six months according to InvestingPro data.
The company’s 50 mg once-daily dose showed a pooled 16.4% placebo-adjusted clinical remission rate after eight weeks across both ABTECT-1 and ABTECT-2 trials. Individually, the 50 mg dose achieved placebo-adjusted remission rates of 19.3% in ABTECT-1 and 13.4% in ABTECT-2, both with high statistical significance.
The trials enrolled 1,275 patients across 600 sites in 36 countries, making it one of the largest Phase 3 ulcerative colitis studies conducted to date. Nearly half (47.3%) of participants had previously inadequate responses to advanced therapies.
"The results of the two induction studies for this first-in-class therapy for ulcerative colitis are both statistically significant and clinically meaningful," said David Rubin, Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, in the press release.
Obefazimod demonstrated a favorable safety profile consistent with previous clinical experience, with no new safety signals observed. The treatment was generally well tolerated across both dose groups.
The ABTECT maintenance trial is ongoing with 678 patients who achieved clinical response in the induction trials. Top-line results from this 44-week maintenance study are expected in Q2 2026.
Pending positive maintenance results, Abivax plans to submit regulatory applications to the FDA and European Medicines Agency in the second half of 2026.
The company reported preliminary cash and cash equivalents of approximately $71.4 million as of June 30, 2025. InvestingPro analysis indicates the company is quickly burning through cash, with negative free cash flow of $166 million in the last twelve months. The company operates with a moderate debt level of $115 million and maintains a current ratio of 1.25.Want deeper insights into Abivax’s financial health and growth potential? InvestingPro subscribers have access to over 10 additional ProTips and comprehensive financial metrics.
In other recent news, Abivax has completed enrollment for its two Phase 3 induction trials for the drug obefazimod, aimed at treating ulcerative colitis. This development is a crucial step in the drug’s progression, with results anticipated in the third quarter of 2025. Analysts from Citizens JMP have reiterated a Market Outperform rating and maintained a $33.00 price target on Abivax, expressing optimism about the drug’s Phase 3 results based on promising Phase 2b data. Piper Sandler also continues to rate Abivax as Overweight, setting a higher price target of $42.00, emphasizing the drug’s differentiated profile. Additionally, Abivax has strengthened its Board of Directors with the appointment of Dr. Dominik Höchli, an immunology expert, as the company approaches this pivotal clinical milestone. Dr. Höchli brings over two decades of experience in the biopharmaceutical industry, which is expected to be instrumental for Abivax. The company’s management has indicated that top-line results from the trials could be released around late July or early August 2025. These developments come as Abivax prepares for the significant release of its Phase 3 trial results.
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