Major Estimate Revision • Jun 04
Consensus EPS estimates fall by 13% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from €3.80m to €3.75m. Losses expected to increase from €3.41 per share to €3.85. Biotechs industry in France expected to see average net income growth of 13% next year. Consensus price target down from €121 to €115. Share price fell 26% to €83.95 over the past week. Breakeven Date Change • Jun 03
No longer forecast to breakeven The 14 analysts covering ABIVAX Société Anonyme no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €6.24m in 2028. New consensus forecast suggests the company will make a loss of €43.4m in 2028. Announcement • Jun 02
Abivax Reports Landmark Phase 3 Abtect Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis Abivax announced positive topline results from the Phase 3 ABTECT maintenance trial evaluating obefazimod, its investigational oral, first-in-class miR-124 enhancer, in adults with moderately to severely active ulcerative colitis. At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ?39.3% and 40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%). Both 25 mg and 50 mg obefazimod met all key secondary endpoints, demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control. Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial (N=580), with no new safety signals. Recently reported Phase 2a/2b open-label extension data (Study 108) demonstrated durable clinical remission and a favorable safety profile with up to seven years of exposure. The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod in ulcerative colitis in late Fourth Quarter 2026. Topline results of Phase 2b induction trial for Crohn’s disease expected mid-year 2027. The Phase 3 ABTECT maintenance trial is a global 44-week multicenter, randomized, double-blind, placebo-controlled trial that evaluated the long-term efficacy and safety of obefazimod at 25 mg and 50 mg administered orally once-daily in adults with moderately to severely active ulcerative colitis. Participants who were clinical responders after the 8-week ABTECT-1 and ABTECT-2 induction trials (N=580) were re-randomized to receive 25 mg obefazimod, 50 mg obefazimod, or placebo. Results from the trial demonstrated that obefazimod met the FDA primary endpoint of placebo-adjusted clinical remission at Week 44 in the 25 mg (?39.3%) and 50 mg (?40.3%) dose groups. Obefazimod met all key secondary endpoints (endoscopic improvement, endoscopic remission, HEMI, corticosteroid free clinical remission, and sustained clinical remission), demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control. Obefazimod demonstrated an overall favorable safety profile in the Phase 3 ABTECT maintenance trial with no new safety signals observed, and the treatment was generally well tolerated. Abivax intends to submit an NDA to the FDA in late Fourth Quarter 2026. % Difference is for obefazimod minus placebo and is based on estimated common risk difference using the Mantel-Haenszel weights adjusting for the randomization stratification factors: clinical remission at maintenance baseline (yes/no), induction treatment (25 mg/50 mg), and maintenance baseline oral corticosteroids usage (yes/no); Clinical remission is defined as SFS = 0 or 1, and RBS = 0 and MES = 0 or 1; Endoscopic improvement is defined as MES = 0 or 1; Endoscopic remission is defined as MES = 0; HEMI is defined as MES = 0 or 1 and Geboes Index score. Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial (N=580), with no new safety signals. Recently reported Phase 2a/2b open-label extension data (Study 108) demonstrated durable clinical remission and a favorable safety profile with up to seven years of exposure. The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod in ulcerative colitis in late Fourth Quarter 2026. Topline results of Phase 2b induction trial for Crohn’s disease expected mid-year 2027. 
