Following Phase III results for its investigational ulcerative colitis therapy obefazimod, French biotech Abivax saw its stock soar 586%, closing at $68.60 on July 23. This marked a record high for the company.
Several brokerages raised their outlooks. Morgan Stanley upgraded Abivax to “Overweight,” increasing its price target from $12 to $71 based on the 16.4% placebo-adjusted remission rate. Piper Sandler raised its target to $70, citing obefazimod’s clinical profile. Leerink Partners previously increased its target to $74, pointing to the strength of the Phase III data.
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On July 22, Abivax announced topline results from its Phase III ABTECT-1 and ABTECT-2 induction trials in adults with moderately to severely active ulcerative colitis. Both studies showed clinical remission at Week 8, based on the adapted Mayo score, for patients who had previously not responded well or were intolerant to standard or advanced therapies.
The stock surge also coincided with Abivax’s US IPO on Nasdaq, which raised $250 million in gross proceeds, including the complete exercise of the underwriters’ option. The proceeds are expected to support ongoing development, including maintenance trials and a planned Phase II study in Crohn’s disease.
Who Is Abivax?
Abivax is a clinical-stage biotechnology company developing oral therapies for chronic inflammatory conditions. Its star candidate, obefazimod, is in late-stage development for ulcerative colitis and is also being studied for Crohn’s disease.
Ulcerative colitis is a long-term inflammatory disease of the colon. It is usually treated with aminosalicylates, corticosteroids, immunosuppressants or biologics. Patients with moderate to severe disease often need multiple therapies, and maintaining remission is a significant challenge.
In the US, as of 2011, approximately 38,000 new cases of ulcerative colitis are diagnosed each year, with overall incidence estimated at 12.2 per 100,000 people.
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Obefazimod’s Performance in Phase III
Obefazimod is an oral small molecule that boosts levels of microRNA-124 (miR-124) — a small regulatory RNA that helps keep immune activity in check — which in turn lowers inflammatory signals such as TNF, IL‑6 and IL‑17 that are elevated in ulcerative colitis.
In both Phase III studies, obefazimod was administered once daily as a 50 mg oral dose.
The ABTECT-1 and ABTECT-2 trials had identical designs, enrolling 1,200 patients across 36 countries. Participants were randomly assigned in a 1:1 ratio to receive either obefazimod or placebo for 8 weeks. Eligible patients had moderate to severe ulcerative colitis and had not responded to at least one prior advanced therapy. The main goal was clinical remission, measured by stool frequency, rectal bleeding and endoscopic findings.
In ABTECT-1, 28.6% of patients taking obefazimod achieved clinical remission at Week 8, compared to 15.4% on placebo. In ABTECT-2, the rates were 27.6% and 14.1%, respectively. Both results were statistically significant. Obefazimod also showed higher rates of endoscopic improvement and mucosal healing, which are measures of reduced inflammation and tissue recovery seen during colonoscopy.
The safety profile aligned with previous findings, with headache, nausea and COVID-19 infection reported most frequently among participants.
A total of 678 out of 1,275 patients from the induction studies have entered the ongoing Phase III maintenance trial, which will evaluate the durability of response over 44 weeks. Topline results from the maintenance trial are expected in the second quarter of 2026.
If successful, Abivax plans to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026.
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