Abivax (ABVX) surges 398.80% pre-market on positive Phase 3 trial results

French biotechnology company Abivax SA (NASDAQ: ABVX) experienced a staggering 400% surge in premarket trading on July 23, 2025, following the release of positive Phase 3 clinical trial results for its ulcerative colitis treatment, obefazimod. The stock opened at $49.88, a 398.80% increase from the previous close of $10.00, with trading volume spiking as investors reacted to the breakthrough data [2]. This marked an extraordinary departure from the stock’s 52-week range of $4.77 to $13.17, pushing its market capitalization to approximately $665 million [2]. The surge was driven by statistically significant outcomes from the ABTECT-1 and ABTECT-2 trials, which evaluated the first-in-class oral miR-124 enhancer in 1,275 patients across 36 countries. The pooled analysis showed a 16.4% placebo-adjusted clinical remission rate at Week 8 for the 50mg once-daily dose, meeting the primary endpoint with high statistical significance (p<0.0001). Individual trial results reported 19.3% and 13.4% remission rates for ABTECT-1 and ABTECT-2, respectively [2].

The trials targeted a population with significant unmet medical needs, as 47.3% of participants had inadequate responses to prior advanced therapies. This included the largest cohort of patients resistant to JAK inhibitors in Phase 3 ulcerative colitis trials to date [2]. The drug’s favorable tolerability profile, with no new safety signals observed, further underscored its potential as a treatment option for patients with limited alternatives. Abivax plans to submit New Drug Applications to the FDA and European Medicines Agency in late 2026, contingent on positive results from an ongoing maintenance trial (ABX464-107) involving 678 patients who achieved clinical response. Topline results from this trial are expected in Q2 2026 [2].

Financially, the company reported preliminary cash and cash equivalents of $71.4 million as of June 30, 2025, providing operational runway for regulatory submissions and development [2]. The firm postponed its Q2 2025 earnings report to September 8, 2025, to focus on the clinical milestone [2]. With a beta of 1.53, ABVX’s stock has historically been highly volatile, amplifying its sensitivity to clinical data releases [2]. The premarket surge, while reminiscent of speculative trading patterns, was grounded in concrete clinical outcomes rather than retail-driven narratives. For instance, a Reddit post referencing the stock surge linked it to a “Solana meme” narrative, but the company’s movement was fundamentally tied to its Phase 3 results [1].

The surge highlights investor confidence in obefazimod’s commercial potential, particularly given its first-in-class status and addressing a patient population with limited treatment options. However, the stock’s trajectory remains contingent on the maintenance trial’s success and regulatory approval timelines. Abivax’s strategic focus on ulcerative colitis, a chronic inflammatory bowel disease affecting millions globally, positions it to capture a niche but critical market segment. The company’s financial disclosures and clinical progress suggest a balance between high-risk, high-reward development and operational prudence, though its beta and cash reserves will remain key indicators for future performance.

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[1] [DD The ABIVAX (ABVX) “Oral Colitis Cure” play](https://www.reddit.com/r/wallstreetbets/comments/1m71fmh/dd_the_abivax_abvx_oral_colitis_cure_play/)

[2] [Why Did ABVX Surge Over 400% in Premarket Trading?](https://tokenist.com/why-did-abvx-surge-over-400-in-premarket-trading/)