Abivax, stock market jumps on Eli Lilly takeover rumours

According to analysts at Oddo BHF, Abivax now looks more like an acquisition target than a stand-alone development story.

The context is one of an industry preparing to lose patent protection on treatments worth $303 billion in annual sales between 2026 and 2031, according to a report by RA Capital. The rush to strengthen pipelines has already supported$130 billion of M&A deals in biopharma in 2025, more than double the previous year's figure.

In France, a review by the Treasury is required, which usually takes about three months, CEO Marc de Garidel said in an interview, stating that he could not comment on whether Abivax had been approached by Eli Lilly. Big pharma, de Garidel stressed from San Francisco, where the JPMorgan Healthcare Conference is underway, cannot ignore the potential of Abivax's experimental drug for inflammatory bowel disease, at a time when the industry is being called upon to replace hundreds of billions of dollars in revenues that are set to disappear due to patent expiries.

'If you are a Big Pharma, you cannot ignore that this product could become one of the most widely used in the next decade,' he said.

The results of the late phase study on obefazimod in ulcerative colitis are expected towards the end of the second quarter, the company announced, which aims to prove that the drug is able to keep patients in remission. If successful, Abivax intends to file for approval in the US by the end of the year and start marketing in the third quarter of 2027, de Garidel explained.

For markets outside the US, the group will instead seek a marketing partner. President Donald Trump's push to bring US drug prices in line with those in other advanced countries will also play a role in these negotiations, as US prices have traditionally been higher and many in the industry have warned that new drugs could be priced higher abroad to support US levels.

"We will not jeopardise the US market for other jurisdictions," de Garidel said, recalling that Abivax has invested $350 million in a late-stage clinical trial. "We cannot allow prices in the US to be influenced by countries that do not want to recognise the value of the work done by Abivax."

On the divestment announced by Sofinnova Partners, de Garidel explained that the stake had been held for some time and that the decision was in response to the fund's need to return capital to its investors.

Abivax, listed on both Euronext Paris and Nasdaq, is a clinical-stage biotech focused on developing therapies that harness the body's natural regulatory mechanisms to stabilise the immune response in chronic inflammatory diseases. Last week it announced its corporate outlook 2026, highlighting new market indications, progress in the ABTECT-UC and ENHANCE-CD studies, and advancement of the therapeutic pipeline.

The CEO at the time commented: 'Looking back on the progress made in 2025, I am deeply grateful to the patients and physicians who contributed to the advancement of our studies, as well as to the employees and investors of Abivax who supported this journey. 2025 was an extraordinary year: we announced positive data from the 8-week phase 3 ABTECT study, which demonstrated the safety and potential of obefazimod as a first-in-class oral therapy for ulcerative colitis, presented updates at major international conferences, and successfully completed a significant capital raise."

Looking ahead to 2026, de Garidel emphasised his intention to "maintain this momentum" by evaluating the data from the phase 3 ABTECT-UC study in maintenance and those from the phase 2 ENHANCE-CD study, as well as identifying new opportunities for pipeline development. "The evidence presented today, derived from the updated market research and safety analyses of the DSMB, demonstrates the important opportunity to concretely impact the needs of millions of patients still inadequately served by current therapies."

Several industry analyses predict significant growth in the ulcerative colitis market in the coming years, driven by the increased use of advanced therapies and the introduction of new mechanisms of action. According to a recent report, global sales in the UC segment are set to more than double from USD 9.2 billion in 2025 to 21.2 billion in 2032.

"In this context, market research conducted after the announcement of the results of the phase 3 induction ABTECT study in July 2025 indicates that obefazimod could emerge as a future market leader, outperforming both currently available and expected upcoming therapies, including TL1A inhibitors and oral anti-IL-23 agents," reads a note from the French biotech.

Estimates indicate that about 500,000 patients in the US are currently treated with conventional therapies (5-ASA and corticosteroids), of which about 60 per cent have moderate or severe disease. Physicians involved in the research reported a likely propensity to start treatment with obefazimod in this population, where reluctance towards advanced therapies limits its use.

The Data Safety Monitoring Board (DSMB) of the phase 3 Abtect study met on 18 December 2025 and found no new signals of concern, with more than 80% of participants having completed the 44-week double-blind maintenance phase. Preliminary (topline) results from the maintenance study are expected at the end of Q2 2026 and could confirm the durability of obefazimod's efficacy and greater treatment extension than currently available options. In parallel, the preparation of the New Drug Application (NDA) is ongoing, with planned discussions with the FDA with a view to a possible filing by the end of 2026.

Obefazimod features a first-in-class mechanism of action, targeted directly at the site of inflammation, the company explains, adding: 'Preclinical evidence of a clear antifibrotic effect in Crohn's disease reinforces the drug's potential as a differentiated therapeutic option. Detailed results, including 22 abstracts, will be presented at the ECCO 2026 annual congress, scheduled to take place in Stockholm from 18-21 February 2026'.

The ENHANCE-CD phase 2b study, evaluating safety and efficacy of obefazimod in patients with moderate to severe Crohn's disease, is in full progress. Results of the 12-week induction are expected in late 2026 and will guide the design of subsequent registration studies.

During 2026, Abivax also plans to share the first preclinical results of combination studies of obefazimod with other agents (including IL-23, a4b7, PDE-4 and AhR), with the selection of a priority combination candidate by the end of the year.

Finally, the evaluation of second-generation miR-124 enhancers in different models of chronic inflammation continues, as well as the analysis of potential opportunities for in-licensing of innovative and complementary assets in inflammatory bowel disease.

Concluding, de Garidel reiterated: 'Thanks to the recently obtained funding, which gives us visibility until the fourth quarter of 2027, we are focused on completing the phase 3 Abtect study in maintenance, developing the phase 2b study in Crohn's disease, and evaluating further opportunities for pipeline growth. Our goal remains to offer safer, more effective and durable therapies to patients with chronic inflammatory diseases such as ulcerative colitis and Crohn's disease."