ABVX

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...

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.

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.

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,...

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...

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....

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

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...

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...

Cormorant Asset Management disclosed a buy of 2,361,260 shares of MoonLake Immunotherapeutics (NASDAQ:MLTX) in its February 17, 2026 SEC filing, an estimated $27.86 million trade based on quarterly average pricing. According to a SEC filing dated February 17, 2026, Cormorant Asset Management increased its stake in MoonLake Immunotherapeutics (NASDAQ:MLTX) by 2,361,260 shares during the fourth quarter. The estimated transaction value, based on the period’s average closing price, was $27.86 million. The quarter-end value of the position increased by $43.11 million, a figure that includes both additional shares and changes in the share price. This was a buy, lifting MoonLake Immunotherapeutics to 2.65% of Cormorant Asset Management, LP’s reportable U.S. equities as of December 31, 2025. Top five holdings after the filing: NASDAQ:PRAX: $280.00 million (15.9% 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 February 17, 2026, shares of MoonLake Immunotherapeutics were priced at $17.52, down nearly 60% over the past year and well underperforming the S&P 500’s roughly 19% gain in the same period. MoonLake Immunotherapeutics develops clinical-stage therapies, with a primary focus on Sonelokimab, an investigational Nanobody therapy targeting inflammatory diseases. The firm operates a research-driven business model, generating value through the advancement of novel biologic drug candidates in trials for dermatological and rheumatological indications. It serves biopharmaceutical markets, targeting healthcare providers and patients affected by chronic inflammatory conditions such as hidradenitis suppurativa and psoriatic arthritis. MoonLake Immunotherapeutics is a clinical-stage biotechnology company specializing in the development of next-generation therapies for inflammatory diseases. The company leverages proprietary Nanobody technology to address significant unmet medical needs in dermatology and rheumatology. With a focused pipeline and ongoing clinical trials, MoonLake aims to establish a competitive position in the biopharmaceutical sector through innovative science and targeted indications. MoonLake Immunotherapeutics’ stock suffered a steep nearly 90% drop in a single day this past September after mixed Phase 3 results surfac...

On February 17, 2026, Eversept Partners disclosed a buy of Vera Therapeutics (NASDAQ:VERA), adding 264,468 shares in a move estimated at $9.39 million based on quarterly average pricing. According to a SEC filing dated February 17, 2026, Eversept Partners increased its position in Vera Therapeutics by 264,468 shares in the fourth quarter. The estimated transaction value is approximately $9.39 million, calculated using the average share price for the quarter. At quarter-end, the value of the fund's Vera Therapeutics holding rose by $73.99 million, a figure that reflects both new purchases and stock price appreciation. Top holdings after the filing: NASDAQ: VERA: $155.58 million (8.7% of AUM) NYSE: GSK: $131.41 million (7.4% of AUM) NASDAQ: UTHR: $123.08 million (6.9% of AUM) NASDAQ: ABVX: $88.71 million (5.0% of AUM) NASDAQ: NTRA: $76.63 million (4.3% of AUM) As of Monday, Vera Therapeutics shares were priced at $39.97, up 43% over the past year and well outperforming the S&P 500’s roughly 19% gain in the same period. Vera Therapeutics develops clinical-stage therapies targeting serious immunological diseases, with a lead product candidate, atacicept, in Phase IIb trials for immunoglobulin A nephropathy, and MAU868 in Phase II for BK viremia infections. The company operates a biotechnology model focused on research, development, and commercialization of proprietary biologic drug candidates, aiming for regulatory approval and future revenue generation from product sales and potential licensing. Primary customers are healthcare providers and patients affected by autoimmune and viral-mediated kidney diseases, with a focus on the United States market. Vera Therapeutics is a clinical-stage biotechnology company specializing in immunological disease treatments, headquartered in Brisbane, California. The company leverages a robust pipeline of biologic candidates to address unmet medical needs in nephrology and infectious diseases. Its strategy centers on advancing innovative therapies through late-stage clinical development to establish a competitive position in the biopharmaceutical sector. Vera’s lead drug candidate, atacicept, is being developed to treat immunoglobulin A nephropathy, a serious kidney disease with limited treatment options. The therapy has already produced positive Phase 3 results and is now under priority review by the FDA, with a decision expect...

Pharming Group PHAR is slated to report fourth-quarter 2025 results on March 12, 2026, before the opening bell. We expect investors to focus on the sales performances of PHAR’s marketed drugs and other pipeline updates when it reports fourth-quarter 2025 results. The Zacks Consensus Estimate for quarterly revenues in the to-be-reported quarter is pegged at $104.8 million. The consensus mark for Pharming Group’s earnings per share is pinned at 15 cents. Let us see how things are likely to have shaped up for PHAR in the soon-to-be-reported quarter. Pharming Group’s total revenues only comprise its product sales. It derives the bulk of its revenues from the sale of Ruconest (conestat alfa), its flagship therapy for treating hereditary angioedema (HAE), which is approved in the United States, the EU and the U.K. Since its launch, Ruconest has become the company’s primary growth engine, driven by a growing patient and prescriber base, which is expected to have boosted fourth-quarter sales as well. In the third-quarter earnings release, Pharming Group announced that it would withdraw Ruconest from all non-U.S. markets, which generated $1.1 million (1.3% of quarterly revenues) and were not financially sustainable. The company will focus on ensuring patient continuity of care while redirecting resources to higher-growth pipeline opportunities. Investors are likely to seek greater clarity on this matter during the fourth-quarter earnings call. Pharming Group’s second marketed product, Joenja (leniolisib), was in-licensed from Novartis and is approved for treating patients (aged 12 years and older), with activated phosphoinositide 3-kinase delta syndrome (APDS) in the United States, the EU and the U.K. Joenja sales are also expected to have grown year over year in the fourth quarter, primarily driven by an increase in U.S. and U.K. patients on paid therapy. Please note that both marketed drugs have also posted sequential growth in all three quarters of 2025. This trend is expected to have continued in the fourth quarter as well. Pharming Group shares have gained 11.5% in the past six months compared with the industry’s 22% growth. Image Source: Zacks Investment Research Investors will also likely be interested in updates regarding PHAR’s mid to late-stage pipeline candidates on the fourth-quarter earnings call. The FDA recently rejected the company’s regulatory applic...