Abivax raises $920M to fund solo U.S. launch of bowel disease drug

Abivax has enough cash to bring its ulcerative colitis drug to the U.S. alone, ending months of speculation that it would sell itself to a larger pharmaceutical company.

Abivax's latest funding round allows the French biotech to move toward a solo U.S. launch of its bowel disease drug without backing from Big Pharma, CEO Marc de Garidel told CNBC after months of intense takeover speculation.

"Thanks to the cash we raised… We are in a position to have cash until the end of 2029, and … build up the right infrastructure to launch in the U.S.," de Garidel told CNBC's "Squawk Box Europe" on Friday.

The Paris-listed biotech, worth nearly 11 billion euros ($12.2 billion), raised $920 million last week after underwriters exercised in full their option to purchase additional American depository shares. Proceeds will finance operations through 2029, including commercialization of its only asset, obefazimod — an oral small molecule that modulates immune response through microRNA-124 regulation, a mechanism distinct from standard anti-TNF therapies used by Johnson & Johnson's Remicade and AbbVie's Humira.

The Takeover Calculus Shifts

Abivax has been under intense scrutiny as a prime acquisition target after reporting strong efficacy data in July 2025 for obefazimod over eight weeks, followed by a 44-week maintenance trial. Analysts modeled a potential acquisition price as high as $23 billion, and de Garidel told CNBC in March he was confident the company could secure a better deal after the maintenance data.

But the company's Paris-listed shares have soared more than 1,600 percent over the past 12 months, complicating price negotiations with aspiring buyers. De Garidel framed the funding as a strategic choice rather than a defensive move.

"The best defense for us is actually the offense," he said Friday when asked whether Abivax would consider a takeover offer.

The decision to go solo carries risks. Abivax has no marketed products and must build a U.S. commercial infrastructure from scratch — a costly undertaking that has tripped up many biotechs before it. The company's lead candidate targets moderate to severe ulcerative colitis, a market dominated by Humira (AbbVie), Stelara (Johnson & Johnson), and Entyvio (Takeda), each generating billions in annual sales.

Safety Questions and the FDA Path

A late-stage trial for obefazimod spooked investors earlier this year after reported cancer cases in the study cohort sent shares crashing. A subsequent analysis from the same trial showed malignancies were in line with normal rates expected for the patient demographic, leading shares to recover.

"When you have ulcerative colitis, unfortunately, your immune system is depleted, and you are more susceptible to a certain type of cancer," de Garidel said, emphasizing the drug's "unmatched efficacy for the drug in a hard-to-treat population" and repeating the company's stance that it is safe.

Abivax will meet with the U.S. Food and Drug Administration at the end of July for a pre-NDA meeting to discuss its New Drug Application for obefazimod. A successful solo launch could dramatically increase the company's valuation and market share in the inflammatory bowel disease space, potentially disrupting larger competitors. The $920 million cash haul significantly reduces near-term dilution risk and removes the dependency on a buyout, likely boosting investor confidence as the company approaches its regulatory milestone.

This article is for informational purposes only and does not constitute investment advice.