ABVX
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Earnings documents stored for ABVX.
Investor releaseQuarter not tagged2026-09-11Earnings To Watch: Abivax SA (XPAR:ABVX) Reports Q2 2026 Result
GuruFocus.com
Earnings To Watch: Abivax SA (XPAR:ABVX) Reports Q2 2026 Result
This article first appeared on GuruFocus. Abivax SA (XPAR:ABVX) is set to release its Q2 2026 earnings on Sep 14, 2026. The consensus estimate for Q2 2026 revenue is 0.00, and the earnings are expected to come in at 0.00 per share. The full year 2026's revenue is expected to be $0.00 and the earnings are expected to be $0.00 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 1 Warning Sign with XPAR:ABVX. Is XPAR:ABVX fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Abivax SA (XPAR:ABVX) have declined from $5.58 million to $5.27 million for the full year 2026 and declined from $188.80 million to $144.64 million for 2027. Earnings estimates for Abivax SA (XPAR:ABVX) have increased from $-4.02 per share to $-3.82 per share for the full year 2026 and increased from $-3.23 per share to $-2.99 per share for 2027. In the previous quarter of 2025-12-31, Abivax SA's (XPAR:ABVX) actual revenue was $2.48 million, which beat analysts' revenue expectations of $2.00 million by 24.15%. Abivax SA's (XPAR:ABVX) actual earnings were $-3.24 per share, which missed analysts' earnings expectations of $-1.50 per share by -116.72%. After releasing the results, Abivax SA (XPAR:ABVX) was down by -7.5% in one day. Based on the one-year price targets offered by 9 analysts, the average target price for Abivax SA (XPAR:ABVX) is $149.00 with a high estimate of $180.00 and a low estimate of $70.00. The average target implies an upside of 48.55% from the current price of $100.30. Based on the consensus recommendation from 9 brokerage firms, Abivax SA's (XPAR:ABVX) average brokerage recommendation is currently 1.70, indicating a "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Investor releaseQuarter not tagged2026-07-31AbbVie Q2 Earnings Call Highlights
MarketBeat
AbbVie Q2 Earnings Call Highlights
Interested in AbbVie Inc.? Here are five stocks we like better. AbbVie exceeded Q2 expectations, reporting nearly $17 billion in revenue, up 10.2% year over year, and adjusted EPS of $3.65. The company raised its full-year revenue outlook by $300 million to approximately $67.6 billion. Growth was led by immunology and neuroscience, with SKYRIZI, RINVOQ and the neuroscience portfolio each delivering more than 20% growth. SKYRIZI’s full-year revenue forecast rose to $21.7 billion, while HUMIRA sales fell 36.1% due to biosimilar competition. AbbVie expects the Apogee Therapeutics acquisition to close in the third quarter, contributing expected EPS dilution and requiring new debt financing. The company also highlighted advancing Parkinson’s, oncology and aesthetics programs, though oncology and aesthetics revenue declined operationally. Abivax: Wall Street Catches Up to the Data AbbVie (NYSE:ABBV) reported second-quarter 2026 results that exceeded its expectations, supported by double-digit growth in its immunology and neuroscience businesses, and raised its full-year revenue outlook by $300 million. Chairman and Chief Executive Officer Rob Michael said adjusted earnings per share totaled $3.65, or $0.06 above the midpoint of the company’s guidance. Net revenues were nearly $17 billion, exceeding AbbVie’s expectations by $300 million and increasing 10.2% year over year. Foreign exchange contributed a 0.7% favorable impact to quarterly revenue growth. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now Hims & Hers Eyes Global Growth: Will $1.15B Eucalyptus Deal Fuel Its Recovery or Dilute Shareholders? “The performance of SKYRIZI, RINVOQ, and our neuroscience portfolio continues to be very strong, with each delivering growth above 20%,” Michael said. Chief Financial Officer Scott Reents said AbbVie now expects approximately $67.6 billion in full-year net revenue, reflecting a $300 million increase from its prior forecast and a roughly 0.5% favorable foreign-exchange impact on annual sales growth. The company has raised total revenue guidance by $600 million since the beginning of the year, according to Michael. → Microsoft Just Flipped the AI Spending Narrative Overnight 5 High-Yield Stocks and ETFs to Buy and Hold for the Next Decade AbbVie updated its full-year adjusted earnings outlook to a range of $13.87 to $14.07 per share. The revised projection incl…Read full documentShow less
Interested in AbbVie Inc.? Here are five stocks we like better. AbbVie exceeded Q2 expectations, reporting nearly $17 billion in revenue, up 10.2% year over year, and adjusted EPS of $3.65. The company raised its full-year revenue outlook by $300 million to approximately $67.6 billion. Growth was led by immunology and neuroscience, with SKYRIZI, RINVOQ and the neuroscience portfolio each delivering more than 20% growth. SKYRIZI’s full-year revenue forecast rose to $21.7 billion, while HUMIRA sales fell 36.1% due to biosimilar competition. AbbVie expects the Apogee Therapeutics acquisition to close in the third quarter, contributing expected EPS dilution and requiring new debt financing. The company also highlighted advancing Parkinson’s, oncology and aesthetics programs, though oncology and aesthetics revenue declined operationally. Abivax: Wall Street Catches Up to the Data AbbVie (NYSE:ABBV) reported second-quarter 2026 results that exceeded its expectations, supported by double-digit growth in its immunology and neuroscience businesses, and raised its full-year revenue outlook by $300 million. Chairman and Chief Executive Officer Rob Michael said adjusted earnings per share totaled $3.65, or $0.06 above the midpoint of the company’s guidance. Net revenues were nearly $17 billion, exceeding AbbVie’s expectations by $300 million and increasing 10.2% year over year. Foreign exchange contributed a 0.7% favorable impact to quarterly revenue growth. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now Hims & Hers Eyes Global Growth: Will $1.15B Eucalyptus Deal Fuel Its Recovery or Dilute Shareholders? “The performance of SKYRIZI, RINVOQ, and our neuroscience portfolio continues to be very strong, with each delivering growth above 20%,” Michael said. Chief Financial Officer Scott Reents said AbbVie now expects approximately $67.6 billion in full-year net revenue, reflecting a $300 million increase from its prior forecast and a roughly 0.5% favorable foreign-exchange impact on annual sales growth. The company has raised total revenue guidance by $600 million since the beginning of the year, according to Michael. → Microsoft Just Flipped the AI Spending Narrative Overnight 5 High-Yield Stocks and ETFs to Buy and Hold for the Next Decade AbbVie updated its full-year adjusted earnings outlook to a range of $13.87 to $14.07 per share. The revised projection includes a $0.10 improvement related to the existing business, offset by $0.14 of anticipated dilution from the planned acquisition of Apogee Therapeutics. The company expects the Apogee transaction to close in the third quarter. Reents said AbbVie has secured interim financing and expects to issue long-term debt in the coming months. The company remains committed to reaching a net leverage ratio of two times within two to three years after closing the deal. → Carrier Earnings Could Send the Stock to a New All-Time High For the third quarter, AbbVie forecast net revenue of about $17.2 billion and adjusted earnings per share of $3.84 to $3.88. That outlook includes a projected 0.4% unfavorable currency impact and partial-quarter dilution related to the planned Apogee acquisition. SKYRIZI full-year revenue is expected to reach $21.7 billion, up $100 million from the prior outlook. Total neuroscience revenue is projected at $12.7 billion, also up $100 million, including VRAYLAR sales approaching $4.1 billion and BOTOX Therapeutic sales approaching $4.2 billion. The remaining $100 million of the revenue guidance increase reflects momentum from RINVOQ and VENCLEXTA. Chief Commercial Officer Jeff Stewart said immunology revenue totaled nearly $8.8 billion during the quarter, increasing 14.6% on an operational basis. SKYRIZI sales reached $5.5 billion, up 24% operationally, while RINVOQ sales exceeded $2.5 billion, increasing 23.7% operationally. SKYRIZI continued to gain share in psoriasis and inflammatory bowel disease, according to Stewart. He said the product has achieved market-share leadership in more than 30 countries and continues to lead total new patient starts in the U.S. IBD market, including in frontline treatment. AbbVie is preparing for a potential U.S. approval of subcutaneous induction dosing for SKYRIZI in Crohn’s disease later this fall. Research and Development Chief Scientific Officer Roopal Thakkar said the regulatory review was proceeding according to plan and that the company had no concerns at the time of the call. Stewart said the subcutaneous induction option could accelerate SKYRIZI’s capture rate in IBD by combining strong efficacy data with a more convenient reimbursement pathway for certain physicians. He expects the commercial effect to build over several months, with more visible momentum beginning in early 2027. Meanwhile, HUMIRA global sales were $756 million, down 36.1% operationally due to biosimilar competition. AbbVie said that performance was in line with its expectations. AbbVie also highlighted recent European approvals of RINVOQ in vitiligo and alopecia areata. U.S. decisions are expected later in 2026 for vitiligo and early 2027 for alopecia areata. Michael said the company now expects the two indications to generate combined peak sales approaching $2 billion, above prior expectations. Neuroscience revenue exceeded $3.2 billion, rising about 20% operationally. VRAYLAR sales were nearly $1.1 billion, up approximately 19%, supported by share gains in bipolar disorder and adjunctive major depressive disorder. AbbVie’s migraine products—BOTOX Therapeutic, UBRELVY and QULIPTA—each posted double-digit sales growth. QULIPTA was approved in Europe for acute migraine treatment as well as once-daily preventive use in chronic or episodic migraine. In Parkinson’s disease, Vyalev sales totaled $256 million, rising more than 27% sequentially. AbbVie said Vyalev remains on track for blockbuster sales this year. The company expects an FDA decision in the third quarter for tavapadon, a selective D1/D5 dopamine agonist for motor symptoms in Parkinson’s disease. Stewart said tavapadon’s initial launch could be modest because the timing of a potential approval would delay placement on Medicare formularies. Still, AbbVie expects its Parkinson’s portfolio of Vyalev, tavapadon and DUOPA to exceed $5 billion in collective peak sales. Oncology revenue was more than $1.6 billion, down 2.4% operationally. VENCLEXTA sales increased 9.6% operationally to $771 million. Growth from ELAHERE, Tepkinly and EMRELIS partly offset a 29.4% operational decline in IMBRUVICA sales, which AbbVie attributed to IRA pricing and competitive pressure. The company also launched DECNUPAZ following FDA approval for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare blood cancer. AbbVie described DECNUPAZ as its first marketed antibody-drug conjugate in hematology. Thakkar outlined further development plans for Temab-A, including an actively recruiting phase III trial in third-line-plus colorectal cancer in combination with bevacizumab. AbbVie expects phase II data later this year from a study of Temab-A combinations versus chemotherapy in second-line colorectal cancer. In aesthetics, revenue was nearly $1.3 billion, down 0.9% operationally. BOTOX Cosmetic revenue increased 3.4% operationally to $728 million, while JUVÉDERM revenue declined 6.6% operationally to $245 million amid continued pressure in dermal fillers. AbbVie recently received approvals in Europe and Canada for Boey, a short-acting aesthetic toxin intended for temporary improvement of glabellar lines. The company said it views the product as a potential way to expand the toxin market by allowing patients to preview cosmetic toxin treatment without a long-lasting result. AbbVie is a global, research-driven biopharmaceutical company that was created as a spin-off from Abbott Laboratories in 2013 and is headquartered in North Chicago, Illinois. The company focuses on discovering, developing and commercializing therapies for complex and often chronic medical conditions. Its operations span research and development, manufacturing, regulatory affairs and commercialization, with an emphasis on bringing specialty medicines to market across multiple therapeutic areas. AbbVie's product portfolio and pipeline cover several major therapeutic categories, including immunology, oncology, neuroscience, virology and women's health. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "AbbVie Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.
Investor releaseQuarter not tagged2026-07-24Abivax's Potential Colitis Drug Showing Positive Results That Bolster Stock Prospects, Morgan Stanley Says
MT Newswires
Abivax's Potential Colitis Drug Showing Positive Results That Bolster Stock Prospects, Morgan Stanley Says
Abivax's (ABVX) drug obefazimod for the potential treatment of ulcerative colitis patients has shown
Investor releaseQuarter not tagged2026-06-29Abivax Reports Positive ABTECT Maintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical Benefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase 3 Maintenance Safety Database
GlobeNewswire
Abivax Reports Positive ABTECT Maintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical Benefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase 3 Maintenance Safety Database
Abivax Reports Positive ABTECT Maintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical Benefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase 3 Maintenance Safety Database Obefazimod delivered meaningful clinical benefit in a highly refractory ulcerative colitis (“UC”) population, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 following continued 50 mg treatment Dose escalation to obefazimod 50 mg recaptured clinical remission in 45.5% of patients who relapsed during ABTECT Maintenance Part 1, supporting a practical dose-escalation strategy for regaining and sustaining disease control over time Across the integrated Phase 2 and Phase 3 UC program (1,704 patient-years of exposure), exposure-adjusted incidence rates (“EAIRs”) for malignancies excluding non-melanoma skin cancer (“NMSC”) were 0.35 and 0.64 events per 100 patient-years (“PYs”), and for NMSC were 0.59 and 0.64 events per 100 PYs in the all-active combined (50 mg + 25 mg) and 50 mg cohorts respectively, all consistent with expected UC background rates In ABTECT Maintenance Part 2, EAIRs for malignancies excluding NMSC were 0.48 and 0.69 events per 100 PYs, and for NMSC were 0.95 and 0.69 events per 100 PYs, in the all-active combined and 50 mg cohorts respectively, all consistent with expected UC background rates Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results PARIS, France – June 29, 2026 – 10:05 pm CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced topline results from ABTECT Maintenance Part 2, the supplemental portion of its Phase 3 UC maintenance program evaluating obefazimod, its investigational oral miR-124 enhancer, in adults with moderately to severely active UC. Part 2 of the Phase 3 Maintenance trial enrolled patients who either did not achieve clinical response following induction treatment or who experienced disease relapse during the re-randomized maintenance trial (Part 1), expanding both the efficacy and safety results in a more refractory…Read full documentShow less
Abivax Reports Positive ABTECT Maintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical Benefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase 3 Maintenance Safety Database Obefazimod delivered meaningful clinical benefit in a highly refractory ulcerative colitis (“UC”) population, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 following continued 50 mg treatment Dose escalation to obefazimod 50 mg recaptured clinical remission in 45.5% of patients who relapsed during ABTECT Maintenance Part 1, supporting a practical dose-escalation strategy for regaining and sustaining disease control over time Across the integrated Phase 2 and Phase 3 UC program (1,704 patient-years of exposure), exposure-adjusted incidence rates (“EAIRs”) for malignancies excluding non-melanoma skin cancer (“NMSC”) were 0.35 and 0.64 events per 100 patient-years (“PYs”), and for NMSC were 0.59 and 0.64 events per 100 PYs in the all-active combined (50 mg + 25 mg) and 50 mg cohorts respectively, all consistent with expected UC background rates In ABTECT Maintenance Part 2, EAIRs for malignancies excluding NMSC were 0.48 and 0.69 events per 100 PYs, and for NMSC were 0.95 and 0.69 events per 100 PYs, in the all-active combined and 50 mg cohorts respectively, all consistent with expected UC background rates Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results PARIS, France – June 29, 2026 – 10:05 pm CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced topline results from ABTECT Maintenance Part 2, the supplemental portion of its Phase 3 UC maintenance program evaluating obefazimod, its investigational oral miR-124 enhancer, in adults with moderately to severely active UC. Part 2 of the Phase 3 Maintenance trial enrolled patients who either did not achieve clinical response following induction treatment or who experienced disease relapse during the re-randomized maintenance trial (Part 1), expanding both the efficacy and safety results in a more refractory patient population than the registrational maintenance cohort. The additional safety results generated through Part 2 expand the Phase 3 maintenance database and provide important context for interpreting the safety findings reported following the Maintenance Part 1 readout. The integrated post-hoc analyses presented today include the new Part 2 results, the combined Phase 3 maintenance program, and the broader Phase 2 and Phase 3 clinical development program. Marc de Garidel, MBA, Chief Executive Officer of Abivax, said: “The results from ABTECT Maintenance Part 2 represent an important milestone in the clinical development of obefazimod, demonstrating meaningful clinical benefit in patients with highly refractory ulcerative colitis while substantially expanding our long-term safety database. Together with the unprecedented efficacy results from the ABTECT Phase 3 program, these findings build a comprehensive body of evidence supporting the potential of obefazimod to address significant unmet needs across a broad spectrum of patients living with ulcerative colitis. “The expanded cumulative safety data further strengthens our confidence in the long-term safety profile of obefazimod and reinforces the favorable benefit-risk profile for our program as we prepare for our planned NDA submission later this year. We believe this growing body of evidence positions obefazimod, if approved, to become a paradigm defining treatment option for patients living with ulcerative colitis.” Clinically meaningful efficacy results observed in induction non-responders following additional obefazimod exposure Among patients who failed to achieve clinical response after 8 weeks of induction, continued treatment with obefazimod resulted in clinically meaningful rates of clinical, endoscopic, and combined histologic-endoscopic endpoints at Week 44. Patients treated continuously with 50 mg obefazimod demonstrated the strongest outcomes across all endpoints, including clinical remission (37.2%), clinical response (61.5%), endoscopic improvement (48.0%), Histologic-Endoscopic Mucosal Improvement (“HEMI”) (44.6%), and endoscopic remission (34.5%). These findings suggest that a meaningful proportion of patients who do not initially respond may still derive substantial benefit from longer treatment exposure. Obefazimod recaptured clinical and endoscopic outcomes in patients who relapsed during maintenance treatment Among patients who relapsed during Maintenance Part 1, re-treatment with 50 mg obefazimod resulted in clinically meaningful rates of clinical remission, clinical response, endoscopic improvement, HEMI and endoscopic remission by Week 44. Patients who achieved clinical response with obefazimod during induction and relapsed after being re-randomized to placebo in Part 1 of the maintenance trial were treated with open-label 50 mg obefazimod and achieved clinical response and remission rates of 69.7% and 45.0%, respectively, while patients who relapsed on 25 mg and escalated to 50 mg achieved clinical response and remission rates of 66.7% and 45.5%, respectively. These findings demonstrate the potential for obefazimod to re-establish disease control following relapse and support a flexible maintenance treatment strategy. Part 2 meaningfully expanded the cumulative safety dataset, increasing confidence in obefazimod’s long-term safety profile The post-hoc analyses below are presented progressively, from the combined Phase 2 and Phase 3 UC programs to the Phase 3 maintenance dataset (Part 1 + Part 2), and then to the Part 2 maintenance dataset, to illustrate how increasing cumulative patient-years strengthens the overall safety assessment. In Part 2, four total NMSC events were reported, two in the 25 mg arm and two in the 50 mg arm, which all occurred in patients with established NMSC risk factors including advanced age, thiopurine use, prior skin cancer history and failure of multiple prior advanced therapies. There were also two non-NMSC malignancies reported in the 50 mg arm, both deemed unrelated to obefazimod by the study investigators. Because NMSCs and malignancies excluding NMSCs are uncommon events, incidence-rate estimates become more precise as cumulative exposure increases. The ABTECT Maintenance data should be interpreted using the totality of the exposure-adjusted evidence, together with patient characteristics and representative published UC epidemiologic reference ranges. The results in the tables below demonstrate that the exposure-adjusted incidence rate in the combined all active (25 mg + 50 mg) treatment arms for both NMSCs and malignancies excluding NMSCs are within the UC background reference range based on published UC studies. Part 2 strengthened confidence in obefazimod’s benefit-risk profile ahead of NDA submission The overall safety results observed in Part 2 were consistent with those previously observed in the broader obefazimod clinical development program. No new safety pattern emerged with the additional cumulative exposure provided by Part 2. Detailed exposure-adjusted analyses by trial, dose, cumulative patient-years, and patient characteristics will be presented during today's investor webcast. Remo Pannacione, M.D., Professor of Medicine and Director of the IBD Clinic at the University of Calgary stated: "The ABTECT Maintenance Trial delivered compelling evidence supporting the clinical potential of obefazimod in ulcerative colitis. The robust efficacy results observed in both induction responders (Part 1) and induction non-responders (Part 2) demonstrate a consistent treatment effect across clinically important patient populations, while the expanding long-term safety dataset continues to provide reassurance, with observed rates of malignancies and non-melanoma skin cancers remaining consistent with expected background rates in ulcerative colitis. Collectively, these findings support a highly favorable benefit-risk profile and strengthen my confidence that obefazimod, if approved, has the potential to become an important new therapeutic option with the ability to meaningfully impact the treatment paradigm for patients with ulcerative colitis." Today's Investor Webcast Abivax management will host a webcast and conference call today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the ABTECT Maintenance Part 2 results. To participate, please use the following dial-in or webcast link: https://edge.media-server.com/mmc/p/o5thz2vd Regulatory Path Forward The ABTECT Maintenance Part 2 results expand the integrated clinical dataset supporting the planned New Drug Application (“NDA”) for obefazimod in UC. The Company remains on track to submit its NDA to the U.S. Food and Drug Administration in the fourth quarter of 2026. Next Anticipated Key Milestones September 21, 2026 – Half-year 2026 financial results Fourth Quarter 2026 – Planned NDA submission for obefazimod in UC Mid-2027 – Topline results from the Phase 2b ENHANCE-CD induction trial evaluating obefazimod in Crohn's disease UC Background Incidence Rate Sources Long et al. Gastroenterology. 2012; Bencardino et al. Cancers (Basel). 2025; Beaugerie et al. The Lancet. 2009; Kaneko et al. Journal of Clinical Medicine. 2024, Lemaitre et al. JAMA. 2017, National Cancer Institute. SEER Statistics. Long et al. Gastroenterology. 2012; Bencardino et al. Cancers (Basel). 2025; Abbas et al. American Journal of Gastroenterology. 2014. About AbivaxAbivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Contact:Patrick MalloySVP, Investor Relations Abivax [email protected] Media Contact:LifeSci CommunicationsKarissa Baltz, Ph.D.Associate [email protected] FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “on track,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the potential therapeutic benefit of obefazimod and obefazimod’s potential to redefine treatment expectations, the expected timing for completion of the Phase 2b ENHANCE-CD induction trial of obefazimod and the availability and timing of results therefrom, the timing of regulatory filings including an NDA submission for obefazimod in UC, the timing for reporting Abivax’s half year 2026 financial results, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission on March 23, 2026 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions. Attachment 260629_Abivax_PR_Positive ABTECT Maintenance Part 2 Results
Investor releaseQuarter not tagged2026-06-17Abivax (ABVX) Reports Q1 2026 Financial Results with Cash Runway Extending Through 2027
Insider Monkey
Abivax (ABVX) Reports Q1 2026 Financial Results with Cash Runway Extending Through 2027
ABIVAX Société Anonyme (NASDAQ:ABVX) is one of the best young stocks to invest in according to hedge funds. On May 22, Abivax reported Q1 2026 financial results, highlighting a solid cash position of €491.6 million, which provides a runway into Q4 2027. R&D expenses rose to €49.5 million, largely driven by ongoing trials for new indications and Crohn’s disease, while general and administrative costs declined due to lower personnel-related expenses. The company also released promising three-year interim data from its Study 108 trial, evaluating obefazimod in patients with ulcerative colitis. Following a de-escalation from 50 mg to 25 mg of once-daily obefazimod, 68% of patients remained in clinical remission at week 144. No new safety signals were observed, further supporting the drug’s potential as a durable, long-term treatment option. 15 States with the Best Healthcare in the US These clinical findings reinforce the company’s progress as it continues to develop obefazimod for chronic inflammatory diseases. With its clinical programs advancing and commercial preparation underway, ABIVAX Société Anonyme (NASDAQ:ABVX) remains focused on its upcoming milestones. ABIVAX Société Anonyme (NASDAQ:ABVX) is a clinical-stage biotech company that develops therapies to stabilize immune responses in chronic inflammatory diseases. Its lead candidate, obefazimod, is currently in advanced clinical trials for the treatment of ulcerative colitis and Crohn’s disease. While we acknowledge the potential of ABVX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-06-17Abivax (ABVX) Reports Positive Phase 3 Maintenance Trial Results for Obefazimod in Ulcerative Colitis
Insider Monkey
Abivax (ABVX) Reports Positive Phase 3 Maintenance Trial Results for Obefazimod in Ulcerative Colitis
ABIVAX Société Anonyme (NASDAQ:ABVX) is one of the best up and coming stocks to buy for the next 3 years. On June 1, Abivax announced positive topline results from its Phase 3 ABTECT maintenance trial for obefazimod, an oral, first-in-class miR-124 enhancer being developed for moderately to severely active ulcerative colitis. At Week 44, both the 25 mg and 50 mg daily doses met the primary endpoint of clinical remission, with placebo-adjusted rates of 39.3% and 40.3%, respectively. Furthermore, both doses successfully met all key secondary endpoints, including endoscopic improvement and remission, demonstrating robust and durable disease control. The trial, which involved 580 participants who were responders to prior induction therapy, showed a favorable safety profile with no new safety signals observed over the 44 weeks. These findings, combined with evidence of long-term durability from open-label extension data, support the company’s plans to submit an NDA to the US FDA for obefazimod in late Q4 2026. Pixabay/Public Domain This milestone reinforces the potential for obefazimod to serve as a convenient, once-daily oral treatment option that could transform the standard of care for ulcerative colitis. Looking ahead, ABIVAX Société Anonyme (NASDAQ:ABVX) continues its clinical development program, with topline results from a Phase 2b induction trial for Crohn’s disease expected in mid-2027. ABIVAX Société Anonyme (NASDAQ:ABVX) is a clinical-stage biotech company that develops therapies to stabilize immune responses in chronic inflammatory diseases. Its lead candidate, obefazimod, is currently in advanced clinical trials for the treatment of ulcerative colitis and Crohn’s disease. While we acknowledge the potential of ABVX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy. Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-06-01Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis
GlobeNewswire
Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis
Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p Both 25 mg and 50 mg obefazimod met all key secondary endpoints, demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial (N=580), with no new safety signals Recently reported Phase 2a/2b open-label extension data (Study 108) demonstrated durable clinical remission and a favorable safety profile with up to seven years of exposure The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod in ulcerative colitis in late Q4 2026 Topline results of Phase 2b induction trial for Crohn’s disease expected mid-year 2027 Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results PARIS, France – June 1, 2026 – 10:05 pm CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced positive topline results from the Phase 3 ABTECT maintenance trial evaluating obefazimod, its investigational oral, first-in-class miR-124 enhancer, in adults with moderately to severely active ulcerative colitis (“UC”). The results demonstrate that both the 25 mg and 50 mg doses of obefazimod met the primary endpoint of clinical remission and all key secondary endpoints at Week 44. Marc de Garidel, MBA, Chief Executive Officer of Abivax, said: “Today’s landmark Phase 3 results highlight the exceptional potential of obefazimod to redefine the treatment landscape for ulcerative colitis. With its compelling durable efficacy and favorable safety profile, combined with the convenience of a once-daily oral treatment, obefazimod has the potential to transform UC patient care.” David T. Rubin, M.D., Chief, Section of Gastroenterology,…Read full documentShow less
Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p Both 25 mg and 50 mg obefazimod met all key secondary endpoints, demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial (N=580), with no new safety signals Recently reported Phase 2a/2b open-label extension data (Study 108) demonstrated durable clinical remission and a favorable safety profile with up to seven years of exposure The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod in ulcerative colitis in late Q4 2026 Topline results of Phase 2b induction trial for Crohn’s disease expected mid-year 2027 Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results PARIS, France – June 1, 2026 – 10:05 pm CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced positive topline results from the Phase 3 ABTECT maintenance trial evaluating obefazimod, its investigational oral, first-in-class miR-124 enhancer, in adults with moderately to severely active ulcerative colitis (“UC”). The results demonstrate that both the 25 mg and 50 mg doses of obefazimod met the primary endpoint of clinical remission and all key secondary endpoints at Week 44. Marc de Garidel, MBA, Chief Executive Officer of Abivax, said: “Today’s landmark Phase 3 results highlight the exceptional potential of obefazimod to redefine the treatment landscape for ulcerative colitis. With its compelling durable efficacy and favorable safety profile, combined with the convenience of a once-daily oral treatment, obefazimod has the potential to transform UC patient care.” David T. Rubin, M.D., Chief, Section of Gastroenterology, Hepatology and Nutrition, and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, commented: “The 44-week maintenance data demonstrate obefazimod’s potential to deliver meaningful efficacy and durable disease control in ulcerative colitis. The novel mechanism, sustained clinical remission, and favorable long-term safety profile highlight its potential to address a significant unmet need in UC.” Topline Results The Phase 3 ABTECT maintenance trial is a global 44-week multicenter, randomized, double-blind, placebo-controlled trial that evaluated the long-term efficacy and safety of obefazimod at 25 mg and 50 mg administered orally once-daily in adults with moderately to severely active UC. Participants who were clinical responders after the 8-week ABTECT-1 and ABTECT-2 induction trials (N=580) were re-randomized to receive 25 mg obefazimod, 50 mg obefazimod, or placebo. Results from the trial demonstrated that obefazimod met the FDA primary endpoint of placebo-adjusted clinical remission at Week 44 in the 25 mg (∆39.3%, p<0.0001) and 50 mg (∆40.3%, p<0.0001) once-daily dose regimens in the Phase 3 maintenance trial. The trial also recorded a 10.4% placebo clinical remission rate, the lowest reported to date in a Phase 3 UC maintenance responder re-randomization trial. Both doses of obefazimod met all key secondary endpoints (endoscopic improvement, endoscopic remission, HEMI1, corticosteroid free clinical remission, and sustained clinical remission), demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control. Obefazimod demonstrated an overall favorable safety profile in the Phase 3 ABTECT maintenance trial with no new safety signals observed, and the treatment was generally well tolerated. Abivax intends to submit an NDA to the FDA in late fourth quarter 2026. % Difference is for obefazimod minus placebo and is based on estimated common risk difference using the Mantel-Haenszel weights adjusting for the randomization stratification factors: clinical remission at maintenance baseline (yes/no), induction treatment (25 mg/50 mg), and maintenance baseline oral corticosteroids usage (yes/no); Clinical remission is defined as SFS = 0 or 1, and RBS = 0 and MES = 0 or 1; Endoscopic improvement is defined as MES = 0 or 1; Endoscopic remission is defined as MES = 0; HEMI is defined as MES = 0 or 1 and Geboes Index score <3.1; Corticosteroid-free clinical remission is defined as clinical remission (SFS = 0 or 1 and RBS = 0 and MES = 0 or 1) at Week 44 and corticosteroid free for at least 12 weeks immediately prior to Week 44; Sustained clinical remission is defined as clinical remission at Week 44 in the sub-population of subjects in clinical remission at Week 8 of the induction trial Fabio Cataldi, MD, Chief Medical Officer of Abivax, added, “Today’s ABTECT maintenance results represent an important milestone for the obefazimod program and we thank the patients, investigators, and site staff who made this trial possible. The totality of the data reinforces obefazimod’s potential to meaningfully change the treatment landscape for ulcerative colitis. We look forward to sharing additional results from this trial at upcoming medical congresses and remain on track for NDA filing for obefazimod in ulcerative colitis by year end.” Anticipated Upcoming Key Milestones Half-year financial results on September 21, 2026 NDA submission for obefazimod in UC in Q4 2026 Topline results of Phase 2b induction trial for Crohn’s disease in mid-year 2027 Investor Conference Call and Webcast Abivax management will host an investor and analyst conference call today at 4:30 p.m. EDT / 10:30 p.m. CEST to discuss the topline results. To participate, please use the following dial-in or webcast link: https://edge.media-server.com/mmc/p/j7jbwm5g/ About the ABTECT Ulcerative Colitis Program The global obefazimod ulcerative colitis program is evaluating more than 1,200 patients with moderately to severely active ulcerative colitis across three pivotal trials. These studies include assessments of efficacy and safety of obefazimod. More information on these trials can be found at www.clinicaltrials.gov (NCT05507203, NCT05507216, NCT05535946). About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Contact: Patrick MalloySVP, Investor RelationsAbivax [email protected]+1 847 987 4878 Media Contact:LifeSci CommunicationsKarissa Baltz, Ph.D.Associate [email protected] FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “on track,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the potential therapeutic benefit of obefazimod and obefazimod’s potential to transform UC patient care, the timing for sharing additional results from the Phase 3 ABTECT maintenance trial, the expected timing for completion of the Phase 2b ENHANCE-CD induction trial of obefazimod and the availability and timing of results therefrom, the timing of regulatory filings including an NDA submission for obefazimod in UC, the timing for reporting Abivax’s half year 2026 financial results, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission on March 23, 2026 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions. 1HEMI: Histologic-Endoscopic Mucosal Improvement2 Treatment-Emergent Adverse Events3 Serious/Severe Infections and Opportunistic Infections: Placebo = Anal abscess, bronchitis & gastroenteritis, 25 mg = 1 Lymph node tuberculosis, 1 tonsillitis, 50 mg = 1 Appendicitis, focal peritonitis Attachment 20260601_Abivax_PR_ABTECT_Ph3 Maintenance Data
Investor releaseQuarter not tagged2026-05-24ABIVAX Société Anonyme (ENXTPA:ABVX) Is Up 6.9% After Long-Term Obefazimod Data And Q1 Results - Has The Bull Case Changed?
Simply Wall St.
ABIVAX Société Anonyme (ENXTPA:ABVX) Is Up 6.9% After Long-Term Obefazimod Data And Q1 Results - Has The Bull Case Changed?
Abivax has reported first-quarter 2026 results, with revenue of €1.34 million and a net loss of €48.47 million, alongside updated loss-per-share metrics. The company also released three-year interim data from its long-term obefazimod ulcerative colitis trial, showing durable clinical remission and no new safety signals over up to seven years of treatment. Next, we’ll examine how the long-term obefazimod data and upcoming Phase 3 and regulatory milestones shape Abivax’s investment narrative. This technology could replace computers: discover 28 stocks that are working to make quantum computing a reality. For Abivax, the core belief is that obefazimod can justify today’s rich valuation and heavy cash burn by ultimately becoming a meaningful ulcerative colitis treatment. The latest Q1 2026 numbers reinforce the current profile: minimal revenue of €1.34 million, sizeable quarterly losses of €48.47 million, and a business still entirely dependent on external funding and future approvals. What does feel incrementally supportive is the three-year interim data from the long-term obefazimod study, showing durable remission and no new safety signals over extended treatment. That aligns well with the upcoming ABTECT Phase 3 maintenance readout and the planned Q4 2026 NDA filing, which remain the dominant near term catalysts. At the same time, the enlarged loss base keeps financing and dilution risk front and center. However, one key financing risk in particular is worth understanding in more detail. ABIVAX Société Anonyme's shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be. Five Simply Wall St Community fair value views range from just €6.17 to over €700 per share, reflecting sharply different expectations. Set that against Abivax’s persistent losses and reliance on a single late stage asset, and you can see why investors might want to weigh several contrasting scenarios for how the story plays out. Explore 5 other fair value estimates on ABIVAX Société Anonyme - why the stock might be worth less than half the current price! Don't just follow the ticker - dig into the data and build a conviction that's truly your own. A great starting point for your ABIVAX Société Anonyme research is our analysis highlighting 2 key rewards and 1 important warning sign that could impact your investment decision. Our free ABIVA…Read full documentShow less
Abivax has reported first-quarter 2026 results, with revenue of €1.34 million and a net loss of €48.47 million, alongside updated loss-per-share metrics. The company also released three-year interim data from its long-term obefazimod ulcerative colitis trial, showing durable clinical remission and no new safety signals over up to seven years of treatment. Next, we’ll examine how the long-term obefazimod data and upcoming Phase 3 and regulatory milestones shape Abivax’s investment narrative. This technology could replace computers: discover 28 stocks that are working to make quantum computing a reality. For Abivax, the core belief is that obefazimod can justify today’s rich valuation and heavy cash burn by ultimately becoming a meaningful ulcerative colitis treatment. The latest Q1 2026 numbers reinforce the current profile: minimal revenue of €1.34 million, sizeable quarterly losses of €48.47 million, and a business still entirely dependent on external funding and future approvals. What does feel incrementally supportive is the three-year interim data from the long-term obefazimod study, showing durable remission and no new safety signals over extended treatment. That aligns well with the upcoming ABTECT Phase 3 maintenance readout and the planned Q4 2026 NDA filing, which remain the dominant near term catalysts. At the same time, the enlarged loss base keeps financing and dilution risk front and center. However, one key financing risk in particular is worth understanding in more detail. ABIVAX Société Anonyme's shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be. Five Simply Wall St Community fair value views range from just €6.17 to over €700 per share, reflecting sharply different expectations. Set that against Abivax’s persistent losses and reliance on a single late stage asset, and you can see why investors might want to weigh several contrasting scenarios for how the story plays out. Explore 5 other fair value estimates on ABIVAX Société Anonyme - why the stock might be worth less than half the current price! Don't just follow the ticker - dig into the data and build a conviction that's truly your own. A great starting point for your ABIVAX Société Anonyme research is our analysis highlighting 2 key rewards and 1 important warning sign that could impact your investment decision. Our free ABIVAX Société Anonyme research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate ABIVAX Société Anonyme's overall financial health at a glance. These stocks are moving-our analysis flagged them today. Act fast before the price catches up: Capitalize on the AI infrastructure supercycle with our selection of the 46 best 'picks and shovels' of the AI gold rush converting record-breaking demand into massive cash flow. Invest in the nuclear renaissance through our list of 88 elite nuclear energy infrastructure plays powering the global AI revolution. The future of work is here. Discover the 35 top robotics and automation stocks leading the charge in AI-driven automation and industrial transformation. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ABVX.PA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-05-22Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data from Study 108, a Phase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose De-Escalation in Patients with Ulcerative Colitis
GlobeNewswire
Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data from Study 108, a Phase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose De-Escalation in Patients with Ulcerative Colitis
Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data from Study 108, a Phase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose De-Escalation in Patients with Ulcerative Colitis Interim intent to treat (“ITT”) analysis from Study 108 supports strong durable clinical remission in moderately to severely active ulcerative colitis (“UC”) patients treated with obefazimod Following two to four years of open-label treatment with 50 mg, 130 patients de-escalated to 25 mg, and at week 144, 68% (88/130) were in clinical remission and 80% (104/130) completed 144 weeks of treatment Patients in Study 108 were treated with obefazimod for up to seven years, with no new safety signals observed ABTECT Phase 3 maintenance trial results expected in late Q2 2026 Cash, cash equivalents and short-term investments of €491.6M as of March 31, 2026; cash runway into Q4 2027 PARIS, France – May 22, 2026 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, reported today its financial results for the first quarter ended March 31, 2026. The first quarter financial statements, approved by the Company’s Board of Directors on May 21, 2026, have been reviewed by the Company’s statutory auditors, and the financial reports will be filed with the French and U.S. securities regulatory authorities, respectively, on May 22, 2026. Study 108: Three-Year Interim Analysis of Long-Term Obefazimod Treatment and Dose De-Escalation in Patients with Moderately to Severely Active UCIn this open-label maintenance (“OLM”) trial, patients who had completed the four-year Phase 2a or two-year Phase 2b OLM trials, where they had received 50 mg of once-daily obefazimod, were given the opportunity to continue receiving obefazimod at a reduced dose of 25 mg daily for up to five additional years (provided they met the eligibility criteria of Mayo Endoscopic Subscore = 0 or 1). A total of 130 patients entered the trial and as of the January 5, 2026 cutoff date, 80% (104/130) were still enrolled and completed the full 144-week evaluation. At study baseline, 89% (116/130) of patients were in clinical remission.…Read full documentShow less
Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data from Study 108, a Phase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose De-Escalation in Patients with Ulcerative Colitis Interim intent to treat (“ITT”) analysis from Study 108 supports strong durable clinical remission in moderately to severely active ulcerative colitis (“UC”) patients treated with obefazimod Following two to four years of open-label treatment with 50 mg, 130 patients de-escalated to 25 mg, and at week 144, 68% (88/130) were in clinical remission and 80% (104/130) completed 144 weeks of treatment Patients in Study 108 were treated with obefazimod for up to seven years, with no new safety signals observed ABTECT Phase 3 maintenance trial results expected in late Q2 2026 Cash, cash equivalents and short-term investments of €491.6M as of March 31, 2026; cash runway into Q4 2027 PARIS, France – May 22, 2026 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, reported today its financial results for the first quarter ended March 31, 2026. The first quarter financial statements, approved by the Company’s Board of Directors on May 21, 2026, have been reviewed by the Company’s statutory auditors, and the financial reports will be filed with the French and U.S. securities regulatory authorities, respectively, on May 22, 2026. Study 108: Three-Year Interim Analysis of Long-Term Obefazimod Treatment and Dose De-Escalation in Patients with Moderately to Severely Active UCIn this open-label maintenance (“OLM”) trial, patients who had completed the four-year Phase 2a or two-year Phase 2b OLM trials, where they had received 50 mg of once-daily obefazimod, were given the opportunity to continue receiving obefazimod at a reduced dose of 25 mg daily for up to five additional years (provided they met the eligibility criteria of Mayo Endoscopic Subscore = 0 or 1). A total of 130 patients entered the trial and as of the January 5, 2026 cutoff date, 80% (104/130) were still enrolled and completed the full 144-week evaluation. At study baseline, 89% (116/130) of patients were in clinical remission. At weeks 48, 96 and 144 of treatment, 73% (95/130), 69% (90/130), and 68% (88/130) of patients evaluated were in clinical remission, respectively. Clinical remission, inclusive of endoscopic subscore, was evaluated in the ITT population using non-responder imputation. Similar trends were observed with other efficacy analyses, and no new safety signals were observed. “The durability of clinical remission observed for up to seven years, together with the favorable tolerability profile observed to date, supports the potential of obefazimod as a durable treatment option for people living with ulcerative colitis,” said Fabio Cataldi, MD, Chief Medical Officer of Abivax. “We look forward to presenting these long‑term data at an upcoming medical meeting.” Abivax provided the following updates on its business and operational goals in press releases published: On January 9, 2026, a press release titled “Abivax Provides 2026 Corporate Outlook” On February 21, 2026, a press release titled “Abivax Presents First Evidence of Anti-Fibrotic Activity for Obefazimod Alongside New Clinical Efficacy and Safety Analyses in Inflammatory Bowel Disease at ECCO 2026” On March 23, 2026, a press release titled “Abivax Announces Full Year 2025 Financial Results and Provides Business Updates” On April 1, 2026, a press release titled “Abivax Publishes Financial Reports with the French and U.S. Securities Regulatory Agencies” On April 20, 2026, a press release titled “Abivax Annual Ordinary and Extraordinary General Meeting of May 11, 2026 Availability of Preparatory Documents” On April 22, 2026, a press release titled “Abivax to Present Data on Obefazimod at Digestive Disease Week®” On May 5, 2026, a press release titled “Abivax Announces Repurchase of Royalty Certificates and Pricing of $45M (€38.5M) Offering of American Depositary Shares” On May 11, 2026, a press release titled “Abivax Announces Results of its May 11, 2026 Annual General Meeting” First Quarter 2026 Financial Highlights Cash Position and Runway: The Company had cash, cash equivalents and short-term investments of €491.6 million as of March 31, 2026, providing a projected cash runway into Q4 2027 based on current operating assumptions. R&D Expenses: Research and development (“R&D”) expenses increased by €10.2 million to €49.5 million (86.0% of operating expenses) in the first quarter of 2026 compared to €39.3 million (81.5% of operating expenses) in the first quarter of 2025. This increase was predominantly driven by expenses related to: G&A Expenses: General and administrative expenses decreased by €(1.7) million to €6.3 million (10.9% of operating expenses) in the first quarter of 2026 compared to €8.0 million (16.7% of operating expenses) in the first quarter of 2025. This decrease is primarily due to decrease in personnel costs, attributable to the decrease in employer tax and social contributions related to our AGAs of €(3.5) million, resulting from the decrease in our share price during the first quarter of 2026 and, to a lesser extent, forfeitures following employee departures and changes in estimates regarding the achievement of vesting conditions. The decrease was partly offset by a €1.4 million increase in consulting and professional fees, driven by costs associated with building our infrastructure to support future growth in our operations. Sales and Marketing Expenses: Sales and marketing expenses increased by €0.9 million to €1.7 million (3.0% of operating expenses) in the first quarter of 2026 compared to €0.9 million (1.8% of operating expenses) in 2025. The increase was driven by costs related to our preparation for potential future sales and commercialization efforts for obefazimod in the U.S. Anticipated Upcoming Key Dates Topline results of UC ABTECT Phase 3 maintenance trial - late Q2 2026 Half-Year Financial Results - September 21, 2026 Topline results of Phase 2b induction trial for CD - Q4 2026 NDA submission for obefazimod in UC - Q4 2026 (subject to positive data) First Quarter 2026 Financial Results (IFRS figures) 1 Includes certain short-term investments (terms of less than 12 months) of €14.2M, making total cash, cash equivalents and short-term investments of €491.6M2 Includes both current and non-current portions of borrowings, convertible loan notes, derivative instruments, and lease liabilities ***** About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “future,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the potential therapeutic benefit of obefazimod, the expected timing for completion of the Phase 3 ABTECT-UC maintenance trial and Phase 2b ENHANCE-CD induction trial of obefazimod and the availability and timing of results therefrom, the timing of regulatory filings including an NDA submission for obefazimod in UC, Abivax’s expectations for regulatory approval and commercialization of obefazimod for UC, Abivax’s cash runway, the timing for reporting Abivax’s half year 2026 financial results, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F for the fiscal year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions. Attachment 20260522_Abivax_PR_Q1 2026
Investor releaseQuarter not tagged2026-05-12Abivax Announces Results of its May 11, 2026 Annual General Meeting
GlobeNewswire
Abivax Announces Results of its May 11, 2026 Annual General Meeting
Abivax Announces Results of its May 11, 2026 Annual General Meeting PARIS, France – May 11, 2026 – 10:05 pm CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, held its annual general meeting of shareholders on May 11, 2026 (the “General Meeting”), which was chaired by Ms. Sylvie Grégoire, Chair of the Board of Directors of Abivax (the “Board”). The shareholders have adopted all the resolutions proposed by the Board, and particularly the financial statements for the 2025 financial year, the compensation policy applicable to the Chairman, the Chief Executive Officer and the directors, as well as delegations granted to the Board related to financial transactions. Details of the vote results will be available on the Company’s website (www.abivax.com). About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Contact: Patrick Malloy SVP, Investor Relations Abivax SA [email protected] +1 847 987 4878 Attachment 2026_05_11_Abivax Announces Results of Annual General Meeting
Investor releaseQuarter not tagged2026-03-24Abivax Announces Full Year 2025 Financial Results and Provides Business Updates
GlobeNewswire
Abivax Announces Full Year 2025 Financial Results and Provides Business Updates
Abivax Announces Full Year 2025 Financial Results and Provides Business Updates ABTECT Phase 3 Data Safety Monitoring Board (DSMB) meeting on March 18, 2026 found no new safety signals; the analysis included 100% of patients randomized, with nearly 90% having completed the 44-week double blind maintenance trial The Company’s pivotal Phase 3 ABTECT maintenance trial evaluating obefazimod for moderately to severely active ulcerative colitis remains on track to report topline results in late Q2 2026 Abivax appointed Michael Nesrallah, MBA as Chief Commercial Officer, bringing extensive IBD leadership experience to support the Company’s next phase of growth; other key senior leadership hires made in Regulatory Affairs and Research to support continued advancements of its programs Cash, cash equivalents and short-term investments of €530.4M as of December 31, 2025; cash runway into Q4 2027 Abivax’s Annual General Meeting (“AGM”) to be held May 11, 2026, and the Company expects to report its first quarter 2026 financial results on May 25, 2026 PARIS, France – March 23, 2026 – 9:05 PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, reported today its financial results for the full year ended December 31, 2025. The 2025 financial statements, approved by the Company’s Board of Directors on March 19, 2026, have been audited by the Company’s statutory auditors, and the financial reports will be filed with the French and U.S. securities regulatory authorities, respectively, on March 23, 2026. Marc de Garidel, MBA, Chief Executive Officer of Abivax, commented: “With a strong financial foundation, we are well positioned to execute on our strategic priorities and prepare for the future. We are pleased with the recent DSMB safety update from our ABTECT maintenance trial and remain on track to report topline results from our ABTECT-UC maintenance trial in late Q2 2026. The addition of Michael Nesrallah as our new Chief Commercial Officer also marks an important step as we build toward potential commercialization and the next phase of growth. Together, these achievements reinforce our momentum and confidence in the path…Read full documentShow less
Abivax Announces Full Year 2025 Financial Results and Provides Business Updates ABTECT Phase 3 Data Safety Monitoring Board (DSMB) meeting on March 18, 2026 found no new safety signals; the analysis included 100% of patients randomized, with nearly 90% having completed the 44-week double blind maintenance trial The Company’s pivotal Phase 3 ABTECT maintenance trial evaluating obefazimod for moderately to severely active ulcerative colitis remains on track to report topline results in late Q2 2026 Abivax appointed Michael Nesrallah, MBA as Chief Commercial Officer, bringing extensive IBD leadership experience to support the Company’s next phase of growth; other key senior leadership hires made in Regulatory Affairs and Research to support continued advancements of its programs Cash, cash equivalents and short-term investments of €530.4M as of December 31, 2025; cash runway into Q4 2027 Abivax’s Annual General Meeting (“AGM”) to be held May 11, 2026, and the Company expects to report its first quarter 2026 financial results on May 25, 2026 PARIS, France – March 23, 2026 – 9:05 PM CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, reported today its financial results for the full year ended December 31, 2025. The 2025 financial statements, approved by the Company’s Board of Directors on March 19, 2026, have been audited by the Company’s statutory auditors, and the financial reports will be filed with the French and U.S. securities regulatory authorities, respectively, on March 23, 2026. Marc de Garidel, MBA, Chief Executive Officer of Abivax, commented: “With a strong financial foundation, we are well positioned to execute on our strategic priorities and prepare for the future. We are pleased with the recent DSMB safety update from our ABTECT maintenance trial and remain on track to report topline results from our ABTECT-UC maintenance trial in late Q2 2026. The addition of Michael Nesrallah as our new Chief Commercial Officer also marks an important step as we build toward potential commercialization and the next phase of growth. Together, these achievements reinforce our momentum and confidence in the path ahead.” Full Year 2025 Financial Highlights Fundraise: On July 28, 2025, Abivax completed its underwritten public offering of 11,679,400 American Depositary Shares, each representing one ordinary share, EUR 0.01 nominal value per share, of the Company, in the United States. The net proceeds, after deducting underwriting commissions and offering expenses, were approximately $700.3 million, equivalent to approximately €597.2 million. Cash Position and Runway: The Company had cash, cash equivalents and short-term investments of €530.4 million as of December 31, 2025, providing a projected cash runway into Q4 2027 based on current operating assumptions. Debt: During the year Abivax settled all tranches of its debt with Kreos Capital VII(UK) Limited and Claret European Growth Capital Fund III SCSp as well as its senior convertible notes with Heights Capital Management. R&D Expenses: Research and development (“R&D”) expenses increased by €31.2 million to €177.8 million (70.9% of operating expenses) in 2025 compared to €146.5 million (79.0% of operating expenses) in 2024. This increase was predominantly driven by expenses related to: A €13.0 million increase in transversal activities related to increased chemistry, manufacturing and controls (“CMC”) and supply chain costs related to the progression of clinical trials and anticipation of future commercial launch; and A €10.2 million increase related to the Company’s Crohn’s disease (“CD”) clinical program, driven by the progression of Phase 2b clinical trials for obefazimod in CD; and A €4.1 million increase related to new indications (including combination therapy) for obefazimod; and A €1.6 million increase related to the Company’s ulcerative colitis (“UC”) clinical program, driven by the continuation of Phase 3 clinical trials for obefazimod in UC 96.5% of R&D expenses related to obefazimod in 2025 compared to 97.4% in 2024. G&A Expenses: General and administrative (“G&A”) expenses increased by €34.7 million to €67.7 million (27.0% of operating expenses) in 2025 compared to €32.9 million (17.8% of operating expenses) in 2024. This increase was primarily due to an increase in personnel costs of €33.4 million mainly explained by an increase in employer taxes and social contributions related to our AGA plans by €27.3 million resulting from the increase in the Company’s share price during the second half of 2025. Sales and Marketing Expenses: Sales and marketing (“S&M”) expenses decreased by €0.8 million to €5.2 million (2.1% of operating expenses) in 2025 compared to €6.0 million (3.2% of operating expenses) in 2024. The decrease is explained by one-time costs of €1.8 million incurred in 2024 for the Company’s corporate re-branding, offset by an increase in personnel costs of €1.6 million, of which €0.8 million relate to an increase in employer taxes and social contributions related to our AGAs resulting from the increase in the Company’s share price during the second half of 2025. Data Safety Monitoring Board (DSMB) Update for ABTECT Phase 3 Trials On March 18, 2026, the independent Data Safety Monitoring Board (“DSMB”) completed a safety review of the ongoing Phase 3 ABTECT-UC maintenance trial and reported no new safety signals. Nearly 90% of enrolled participants have completed the 44-week treatment period. This positive update supports the continued advancement of the program as the Company remains on track to report topline results from its ABTECT-UC maintenance trials in late Q2 2026. Board of Directors Update On March 19, 2026, Sofinnova Partners, represented by Dr. Kinam Hong, stepped down from the Company’s Board of Directors. The Company thanks Sofinnova and Dr. Hong for their long-standing commitment, leadership, and partnership over the years. Key Management Updates To support its next phase of growth and continued advancement of its development programs, the Company has strengthened its leadership team with the appointment of Michael Nesrallah as its Chief Commercial Officer, Keith Fournier, PhD, as Senior Vice President of Global Regulatory Affairs, and Maurus de la Rosa, PhD, as its Senior Vice President of Research. These additions further enhance the Company’s commercial, regulatory and scientific capabilities as the Company continues to execute its business priorities. Michael Nesrallah, MBA, Chief Commercial Officer of Abivax, added: “Abivax is entering an exciting new chapter, and I’m thrilled to be joining the Company at such a pivotal moment. We have a meaningful opportunity ahead to further strengthen our commercial capabilities to prepare for the successful launch of obefazimod, if approved, which has the potential to truly make a difference for patients. I look forward to working with the team to help drive the Company’s continued growth and long-term success.” Michael Nesrallah, MBA - Chief Commercial Officer Mr. Nesrallah will lead global commercial strategy and launch preparation as the Company advances toward potential regulatory approval and market entry for obefazimod, bringing more than 20 years of global biopharmaceutical leadership experience with deep expertise in gastroenterology and immunology. Prior to joining Abivax, he held several senior leadership roles at Takeda, including Vice President and U.S. Franchise Head for its inflammatory bowel disease business, where he drove significant growth for Entyvio while expanding treatment access for patients. He also served as General Manager for Belgium and Luxembourg and later established and led Takeda’s International Marketing & Commercial Excellence organization, building integrated commercial capabilities across more than 60 countries to support launch readiness and portfolio growth. Earlier in his career, Mr. Nesrallah held commercial leadership roles at Novartis and began his career at McKinsey & Company. He holds an MBA from the Richard Ivey School of Business and a Bachelor of Science in Biochemistry from the University of Ottawa. Keith Fournier, PhD - Senior Vice President, Global Regulatory Affairs Dr. Keith Fournier is an experienced regulatory affairs executive with extensive expertise in global regulatory strategy and lifecycle management. Most recently, he served as Vice President, Global Regulatory Affairs, at EMD Serono, where he led regulatory planning and agency interactions across key therapeutic areas, supporting product development, approvals and post-marketing activities. He also held senior regulatory roles at AbbVie, where he led global regulatory strategy across multiple programs. He brings deep experience navigating complex global regulatory environments to advance innovative therapies. He holds a PhD in Pharmacology from the University of Pennsylvania, as well as a Bachelor of Science in Biology and a Bachelor of Arts in Economics from Duke University. Maurus de la Rosa, PhD - Senior Vice President, Research Dr. Maurus de la Rosa is a seasoned immunologist with more than 15 years of experience in immunomodulation and drug development across multiple programs, modalities, and development stages. He brings extensive expertise in immunology spanning discovery, translational research, and clinical development, including advanced therapies such as cell and gene therapy. Prior to joining Abivax, Maurus served as Vice President of Research at Sangamo Therapeutics, where he led and successfully advanced CAR-Treg programs for autoimmune diseases including multiple sclerosis and inflammatory bowel disease, with a focus on Crohn’s disease. Earlier in his career, he held research leadership roles at Baxter, Baxalta, Shire, and Takeda, contributing to translational programs and regulatory filings including INDs and BLAs. He holds a PhD in Immunology from Humboldt University in Berlin, and earned a degree in Chemistry with a specialization in Molecular Biology from the University of Cologne. The Company also announced that Didier Scherrer, Chief Scientific Officer will be leaving Abivax after 17 years with the organization, having been with the Company from its earliest stages of development. Management extends its sincere thanks to Dr. Scherrer for his many contributions to the advancement of obefazimod and to the Company over nearly two decades and wishes him the very best in his future endeavors. Anticipated Upcoming Key Dates Annual General Meeting to be held May 11, 2026 Q1 2026 Financial Results to be reported on May 25, 2026 Completion of UC ABTECT Phase 3 maintenance trial - late Q2 2026 Completion of Phase 2b induction trial for CD - Q4 2026 NDA submission for obefazimod in UC - Q4 2026 (subject to positive data) 2025 financial results (IFRS figures) 1 Includes certain short-term investments (terms of less than 12 months) of €13.7M, making total cash, cash equivalents and short-term investments of €530.4M 2 Includes both current and non-current portions of borrowings, convertible loan notes, derivative instruments, and lease liabilities The net loss for the year ended December 31, 2025 of €336.1 million includes the following significant (greater than €1.5M) income/(expenses) that, by nature, did not impact our cash position in the current period and will not in future periods: ***** About Abivax Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. Contacts: Patrick Malloy SVP, Investor Relations Abivax SA [email protected] +1 847 987 4878 Media Contacts: LifeSci Communications Karissa Cross, PhD Associate Director [email protected] FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “on track,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the potential therapeutic benefit of obefazimod, the expected timing for completion of the Phase 3 ABTECT-UC maintenance trial and Phase 2b ENHANCE-CD induction trial of obefazimod and the availability and timing of results therefrom, the timing of regulatory filings including an NDA submission for obefazimod in UC, Abivax’s expectations for regulatory approval and commercialization of obefazimod for UC, Abivax’s cash runway, the timing for reporting Abivax’s Q1 2026 financial results, Abivax’s expectations of announcing of a new independent director, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F for the fiscal year ended December 31, 2025 to be filed with the U.S. Securities and Exchange Commission under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions. Attachment 20260323_Abivax_PR_FY 2025 Results and Business Updates
Investor releaseQuarter not tagged2026-03-17This Biotech Stock Up 700% Is Still a Top Holding Despite a $9.3 Million Sale Last Quarter
Motley Fool
This Biotech Stock Up 700% Is Still a Top Holding Despite a $9.3 Million Sale Last Quarter
Cormorant Asset Management disclosed a sale of 50,000 shares of Praxis Precision Medicines (NASDAQ:PRAX) in a February 17, 2026, SEC filing, with an estimated transaction value of $9.31 million based on the quarter’s average share price. According to a February 17, 2026, SEC filing, Cormorant Asset Management reduced its stake in Praxis Precision Medicines by 50,000 shares during the fourth quarter of 2025. The estimated value of the shares sold was $9.31 million, based on the average unadjusted closing price for the quarter. The quarter-end value of the PRAX stake increased by $227.00 million, a figure that includes both the impact of trading and price movement. Top holdings after the filing: NASDAQ:PRAX: $280.00 million (12.9% of AUM) NASDAQ:BBOT: $223.84 million (12.7% of AUM) NASDAQ:ABVX: $182.05 million (10.3% of AUM) NASDAQ:EYPT: $151.00 million (8.6% of AUM) NASDAQ:RAPP: $91.85 million (5.2% of AUM) As of Monday, PRAX shares were priced at $305.00, up a staggering 700% over the past year and well outperforming the S&P 500’s roughly 19% gain in the same period. Praxis Precision Medicines develops clinical-stage therapies for central nervous system disorders, with lead candidates targeting major depressive disorder, perimenopausal depression, essential tremor, and severe epilepsy. The firm operates a research-driven biopharmaceutical model, advancing proprietary drug candidates through clinical trials and entering into multiple license and collaboration agreements. It targets patients with neurological and psychiatric conditions, as well as healthcare providers and partners in the biotechnology and pharmaceutical sectors. Praxis Precision Medicines is a Boston-based biotechnology company focused on developing innovative therapies for neurological disorders characterized by neuronal imbalance. The company leverages a diversified pipeline of small molecules and antisense oligonucleotides, supported by strategic partnerships and licensing agreements. Its clinical-stage assets and specialized focus position it to address significant unmet medical needs in central nervous system therapeutics. When a biotech stock has such a staggering surge in a single year, trimming a position can be less about losing conviction and more about managing risk during a dramatic run. Praxis Precision Medicines has become one of the standout performers in the neuroscience biotec…Read full documentShow less
Cormorant Asset Management disclosed a sale of 50,000 shares of Praxis Precision Medicines (NASDAQ:PRAX) in a February 17, 2026, SEC filing, with an estimated transaction value of $9.31 million based on the quarter’s average share price. According to a February 17, 2026, SEC filing, Cormorant Asset Management reduced its stake in Praxis Precision Medicines by 50,000 shares during the fourth quarter of 2025. The estimated value of the shares sold was $9.31 million, based on the average unadjusted closing price for the quarter. The quarter-end value of the PRAX stake increased by $227.00 million, a figure that includes both the impact of trading and price movement. Top holdings after the filing: NASDAQ:PRAX: $280.00 million (12.9% of AUM) NASDAQ:BBOT: $223.84 million (12.7% of AUM) NASDAQ:ABVX: $182.05 million (10.3% of AUM) NASDAQ:EYPT: $151.00 million (8.6% of AUM) NASDAQ:RAPP: $91.85 million (5.2% of AUM) As of Monday, PRAX shares were priced at $305.00, up a staggering 700% over the past year and well outperforming the S&P 500’s roughly 19% gain in the same period. Praxis Precision Medicines develops clinical-stage therapies for central nervous system disorders, with lead candidates targeting major depressive disorder, perimenopausal depression, essential tremor, and severe epilepsy. The firm operates a research-driven biopharmaceutical model, advancing proprietary drug candidates through clinical trials and entering into multiple license and collaboration agreements. It targets patients with neurological and psychiatric conditions, as well as healthcare providers and partners in the biotechnology and pharmaceutical sectors. Praxis Precision Medicines is a Boston-based biotechnology company focused on developing innovative therapies for neurological disorders characterized by neuronal imbalance. The company leverages a diversified pipeline of small molecules and antisense oligonucleotides, supported by strategic partnerships and licensing agreements. Its clinical-stage assets and specialized focus position it to address significant unmet medical needs in central nervous system therapeutics. When a biotech stock has such a staggering surge in a single year, trimming a position can be less about losing conviction and more about managing risk during a dramatic run. Praxis Precision Medicines has become one of the standout performers in the neuroscience biotech space. The company is advancing multiple late-stage therapies targeting neurological disorders such as essential tremor and severe epilepsy. Two of its most advanced programs, ulixacaltamide and relutrigine, have already gotten regulatory review after the company submitted new drug applications to the FDA, positioning Praxis for a potential transition from a development-stage biotech to a commercial drug maker. Financially, the company appears well capitalized for that transition. Praxis finished 2025 with roughly $926 million in cash and investments and strengthened its balance sheet further with a $621 million public offering early in January, providing enough runway to fund operations into 2028, management says. Within the broader portfolio, Praxis represents the fund’s largest holding, ahead of other biotech bets such as Abivax and EyePoint Pharmaceutical and certainly suggesting Cormorant believes there could be further upside. Before you buy stock in Praxis Precision Medicines, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Praxis Precision Medicines wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $514,000!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,105,029!* Now, it’s worth noting Stock Advisor’s total average return is 930% — a market-crushing outperformance compared to 187% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of March 16, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This Biotech Stock Up 700% Is Still a Top Holding Despite a $9.3 Million Sale Last Quarter was originally published by The Motley Fool

