Abivax soars 500% on TOP-Line data

The French biotech firm unveiled headline data from its twin 8-week Phase 3 studies—ABTECT-1 and ABTECT-2—demonstrating that a 50 mg once-daily dose of obefazimod achieved a compelling placebo-adjusted clinical remission rate of 16.4% (p<0.0001) when data from both trials were pooled.

Individually, the drug posted a 19.3% placebo-adjusted remission rate in ABTECT-1 (p<0.0001) and 13.4% in ABTECT-2 (p=0.0001). The treatment also met all key secondary endpoints, offering statistically significant and clinically meaningful improvements across a range of measures.

Obefazimod was generally well tolerated with no new safety concerns, reinforcing its profile as a promising treatment candidate for patients with UC, particularly those who have previously failed advanced therapies. Nearly half (47.3%) of the trial participants had an inadequate response to prior advanced treatments, including the largest group of patients with insufficient response to JAK inhibitors ever enrolled in a Phase 3 UC programme.

“This is a monumental day for Abivax and the ulcerative colitis community,” said Marc de Garidel, CEO of Abivax. “The strength and consistency of the induction data reinforce obefazimod’s potential to redefine treatment for UC patients. Pending successful maintenance results, we’re preparing for a regulatory submission in the second half of 2026.”

The maintenance portion of the ABTECT programme (Study 107) is ongoing, with top-line data anticipated in Q2 2026. Of the 1,275 patients initially enrolled, 678 achieved clinical response and have entered the long-term extension phase.

Dr David Rubin, Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, added: “The results of these two induction trials are not only statistically robust but also offer real clinical promise. If the maintenance data holds, obefazimod could become a highly valuable treatment option—both early in the treatment course and for those who’ve exhausted other therapies.”

A major endeavour

The ABTECT programme ranks among the most extensive Phase 3 trials ever undertaken in ulcerative colitis, spanning over 600 sites across 36 countries. Its significance in addressing a persistent unmet need has not gone unnoticed by investors. The 500% surge in Abivax’s stock price underscores both market confidence in the drug’s commercial potential and the acute demand for effective UC treatments.

Dr Fabio Cataldi, Abivax’s Chief Medical Officer, credited the “rigour and discipline” of the company’s clinical team. “These data not only meet but surpass the benchmarks set in our Phase 2b study. We look forward to presenting deeper insights, especially regarding outcomes in patients previously treated with JAK inhibitors, at an upcoming medical congress.”

In light of these developments, Abivax has postponed its scheduled H1 2025 financial results announcement to 8 September. As of 30 June, preliminary unaudited figures indicate cash and cash equivalents of approximately $71.4 million (€61.0 million).

Damian Choplain from European Stifel Bank stated: “The favourable safety/tolerability profile seen in the previous trial was confirmed. Next steps should be 1/ a fundraising to extend the financial runway into Q3 2026, 2/ the release of maintenance data in Q2 2026 followed by the submissions of NDA/MAA to the FDA/EMA in H2 2026, and 3/ a potential strategic transaction including a sale of the company to a big pharma.”

Late breaking public offering (*)

As if Abivax was listening to this analyst, the company announced just yesterday late (10pm european time)  the launch of an approximately US$400 million underwritten public offering (representing approximately €340 million) consisting of a public offering of its American Depositary Shares, each representing one ordinary share, €0.01 nominal value per share, of the Company in the United States. In connection with the Offering, the Company intends to grant the underwriters for the offering a 30-day option to purchase additional ADSs, in an amount of up to 15% of the total number of ADSs proposed to be sold in the offering, on the same terms and conditions. Whether, when and to which extent this offering´s proceedings will fill the account of Abivax will be seen in the next few days.

However, this first public offering was not the end of the story; it developed into a serial novel. Following very strong feedback, Abivax had to pause trading on the stock exchange before Thursday’s opening, as it was no longer possible to calculate the weighted average price of the offering. It took until the afternoon for the situation to become clearer again, after which another public offering was launched: an underwritten public offering of 10,156,000 American Depositary Shares, each representing one ordinary share with a nominal value of €0.01 per share, in the United States. The new offering price was $64.00 per ADS, which translates to €554.3 million, or up to €637.5 million if additional options on ADSs were exercised. This could therefore mean a doubling of the original approach – quite a lot has happened at Abivax in a few hours.

* And, on Friday (25th) morning, Abivax announced the success of its adjusted public offering at the highest value: Following the exercise in full of the option, the total number of ADSs issued in the offering will amount to 11,679,400 ADSs, resulting in gross proceeds for the company of approximately US$747.5 million (€637.5 million) and estimated net proceeds, after deducting underwriting commissions and estimated offering expenses payable by the company, of approximately US$700.3 million (€597.2 million).

The biotech world will undoubtedly be watching closely, as this milestone may well mark the emergence of a new era in ulcerative colitis treatment—and a defining moment in Abivax’s trajectory and value proposition.

*due to new developments, this article has been updated accordingly, trying to keep pace