| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
NDA Submission example | NDA | — | Subscribe to access the data. | Small Molecules | Digestive System | ||
NDA Submission example | NDA | — | Subscribe to access the data. | Small Molecules | Digestive System | ||
NDA Submission example | NDA | — | Subscribe to access the data. | Small Molecules | Digestive System |
Recent Updates
Recently added Catalysts
Abivax SA$139.9
-1.24 (-0.88%)
C 48Pipeline Score Richly Valued Pharma · Commercial
Market Cap
9.79 B
EPS
-5.25
P/E Ratio
-
Value Trade
610.77 M
2.64 %
Week
7.57 %
1 Month
-6.49 %
3 Month
1.65 %
6 Month
951.64 %
5 Year
951.64 %
All Time
Cash Data
Cash Position
12.35 K
Monthly Burn
12.35 K
Runway
12,345 mo
Overview
Volume
837.74 K
52 Week Range
5.62 - 148.83
% held by Insiders
14.44 %
% held by Institutions
48.95 %
Enterprise Value
9.26 B
Total Shares
79.69 M
Short %
6.55 %
Float Shares
68.13 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Abivax SA
145Total events
9Upcoming
25Tier-1 (high impact)
2023 – 2029Coverage
Upcoming catalysts 9
Event history 136
Jul 2, 2026
▼Equity OfferingCorporate
Full exercise of underwriters' option to purchase additional ADSs, bringing gross proceeds to $920M
Jul 1, 2026
Jul 1, 2026
▲Runway Guidance UpdateCorporate
Cash runway extended into Q2 2029 with net proceeds from offering
Jun 30, 2026
▼Equity OfferingCorporate
Launch of underwritten public offering of American Depositary Shares
Jun 29, 2026
▲Topline ReadoutObefazimodClinical Data
Topline results from ABTECT Maintenance Part 2
ulcerative colitissource ↗
Jun 29, 2026
●Oral PresentationObefazimodPresentation
Investor webcast discussing ABTECT Maintenance Part 2 results
ulcerative colitissource ↗
Jun 1, 2026
▲Primary Endpoint MetObefazimodClinical Data
Obefazimod met primary endpoint of clinical remission at Week 44 in Phase 3 ABTECT maintenance trial
moderately to severely active ulcerative colitissource ↗
Jun 1, 2026
●Oral PresentationObefazimodPresentation
Investor conference call to discuss topline results
moderately to severely active ulcerative colitissource ↗
Drug Pipeline Intelligence
C48
Pipeline Score $1.4B
Pipeline ValueRichly Valued
Valuation Signal4
Drugs Scored0.2x
rNPV / MCap Top 72%
Small Cap (rank 256 of 911)
Percentile RankAbivax SA carries a moderate pipeline score (48/100), with $2.3B risk-adjusted pipeline value, led by ABX464 in HIV Infection (Phase 2), across $113B in total addressable markets.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ABX464 Small molecule | Ulcerative Colitis | Phase 3 | NCT05177835 | 58% | $1.6B | ACTIVE NOT_RECRUITING | 3,220 | AVERAGE | D (30) | Apr 1, 2028 | LOW_RISK | MEDIUM May 26, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
obefazimod | refractory ulcerative colitis | Phase 3 | 2026-06-29 | clinical remission: 37.2%; endoscopic remission: 34.5%; relapse remission: 45.5%; EAIR malignancies excluding NMSC: all active combined 0.48 events per 100 PYs, 50 mg cohort 0.69 events per 100 PYs; EAIR NMSC: all active combined 0.95 events per 100 PYs, 50 mg cohort 0.69 events per 100 PYs Read More | 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 Read More | |
obefazimod | refractory ulcerative colitis | Phase 3 | 2026-06-29 | clinical remission: 37.2%; endoscopic remission: 34.5%; relapse remission: 45.5%; EAIR malignancies excluding NMSC: all active combined 0.48 events per 100 PYs, 50 mg cohort 0.69 events per 100 PYs; EAIR NMSC: all active combined 0.95 events per 100 PYs, 50 mg cohort 0.69 events per 100 PYs Read More | 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 Read More | |
obefazimod | refractory ulcerative colitis | Phase 3 | 2026-06-29 | clinical remission: 37.2%; endoscopic remission: 34.5%; relapse remission: 45.5%; EAIR malignancies excluding NMSC: all active combined 0.48 events per 100 PYs, 50 mg cohort 0.69 events per 100 PYs; EAIR NMSC: all active combined 0.95 events per 100 PYs, 50 mg cohort 0.69 events per 100 PYs Read More | 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 Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in ABVX
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
ABVX Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-07-31 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-31 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-31 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
ABVXAbivax Announces Closing of $920 Million Public Offering
Abivax has announced the successful closing of a $920 million public offering of American Depositary Shares. The offering included the full exercise of underwriters' options, resulting in net proceeds of approximately $874.1 million. The company anticipates that these funds will support its operations through the fourth quarter of 2029.
Read more →ABVX▲ +9.1%on this newsshared move
Abivax Announces Full Exercise of Underwriters’ Option to Purchase Additional ADSs, Bringing Gross Proceeds of Offering to $920M (€807M)
Abivax has announced the full exercise of underwriters' option to purchase additional ADSs, resulting in total gross proceeds of approximately $920 million. The additional shares will be delivered alongside the closing of the offering, expected on July 6, 2026. The funds will primarily support the commercialization of obefazimod and ongoing clinical research.
Read more →ABVXCorrection: Abivax Announces Pricing of Highly Oversubscribed and Upsized $800M (€702M) Public Offering of American Depositary Shares
Abivax has announced the pricing of an upsized public offering of American Depositary Shares (ADSs) totaling $800 million, increased from the initial $600 million. The offering price is set at $125.00 per ADS, reflecting a 2.39% premium to the recent trading average. The proceeds are expected to support the commercialization of the drug candidate obefazimod and extend the company's cash runway into Q2 2029.
Read more →ABVXAbivax Announces Pricing of Oversubscribed and Upsized $800M (€702M) Public Offering of American Depositary Shares
Abivax has announced the pricing of its upsized public offering, raising $800M through the sale of 6.4 million American Depositary Shares at $125 each. The offering, which was increased from an initial $600M, is expected to extend the company's cash runway into Q2 2029, aiding in the commercialization of its lead drug candidate, obefazimod. The offering is set to close on July 6, 2026, subject to customary conditions.
Read more →ABVXAbivax Announces Launch of Public Offering of American Depositary Shares
Abivax has announced a public offering of approximately $600 million of American Depositary Shares. The funds raised are intended for the commercialization of its lead drug candidate, obefazimod, and for clinical research related to ulcerative colitis and Crohn's disease. The offering is subject to market conditions and may involve dilution for existing shareholders. Trading of the company's ordinary shares on Euronext is expected to be suspended temporarily during this process.
Read more →ABVX▲ +38.6%on this news· ran to +50% by day 3shared move
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 announced positive results from the ABTECT Maintenance Part 2 trial of obefazimod in refractory ulcerative colitis patients. The study demonstrated significant clinical benefits, including high remission rates among previously non-responding patients. The expanded safety database supports the drug's long-term safety profile, bolstering confidence ahead of a planned NDA submission.
Read more →ABVX▼ -44.1%on this news
Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis
Abivax announced positive results from the Phase 3 ABTECT trial for obefazimod, showing significant efficacy in achieving clinical remission in patients with moderately to severely active ulcerative colitis. Both 25 mg and 50 mg doses met primary and secondary endpoints, indicating robust disease control. The drug also exhibited a favorable safety profile, with plans for an NDA submission to the FDA by late 2026.
Read more →ABVXAbivax 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 reported its first quarter 2026 financial results and shared interim data from Study 108, which indicates that 68% of patients with moderately to severely active ulcerative colitis achieved clinical remission after de-escalating their obefazimod dosage. The company has a cash position of €491.6 million, ensuring operational stability into late 2027. Upcoming results from the Phase 3 ABTECT trial are anticipated in late Q2 2026.
Read more →ABVXAbivax Annouces Results of its
Abivax reported the outcomes of its annual general meeting held on May 11, 2026, where all proposed resolutions were adopted by shareholders. This includes approval of the financial statements for the year 2025 and the compensation policy for key executives. The company, focused on chronic inflammatory disease therapies, is advancing its lead drug candidate, obefazimod, which is currently in Phase 3 trials for ulcerative colitis. Further details on the meeting's voting results will be made available on the company's website.
Read more →ABVXAbivax Announces Results of its May 11, 2026 Annual General Meeting
Abivax held its annual general meeting on May 11, 2026, where shareholders approved all resolutions proposed by the Board. This includes the financial statements for the 2025 financial year and the compensation policy for executives. The company continues to advance its lead drug candidate, obefazimod, in Phase 3 clinical trials for ulcerative colitis.
Read more →ABVX▲ +5.7%on this news
Abivax Announces Repurchase of Royalty Certificates and Pricing of $45M (€38.5M) Offering of American Depositary Shares
Abivax announced the repurchase of royalty certificates and the pricing of a $45 million offering of American Depositary Shares (ADSs). The offering is expected to close on May 7, 2026, and aims to enhance the company's financial flexibility and support its clinical programs. The repurchase is part of a strategy to simplify the capital structure and strengthen the balance sheet.
Read more →ABVXAbivax to Present Data on Obefazimod at Digestive Disease Week
Abivax announced it will present nine abstracts on obefazimod at the upcoming Digestive Disease Week in Chicago. These presentations will focus on the Phase 3 ABTECT program, showcasing efficacy, safety, and patient-reported outcomes for patients with ulcerative colitis. The company's executives expressed confidence in obefazimod's ability to provide significant advancements in treatment. The findings are expected to enhance understanding of the drug's therapeutic potential in inflammatory bowel disease.
Read more →ABVXAbivax Annual Ordinary and Extraordinary General Meeting of May 11, 2026 Availability of the Preparatory Documents
Abivax SA will hold its Annual Ordinary and Extraordinary General Meeting on May 11, 2026, in Paris. Shareholders are informed about relevant agenda items and resolutions, with detailed preparatory documents available per legal requirements. The company focuses on therapeutics aimed at regulating immune responses in chronic inflammatory diseases and is advancing its lead candidate, obefazimod, in Phase 3 trials for ulcerative colitis.
Read more →ABVXAbivax Publishes Financial Reports with the French and U.S. Securities Regulatory Agencies
Abivax SA has filed its Universal Registration Document with French regulators and its Annual Report with the U.S. SEC as of March 23, 2026. The documents contain the 2025 annual financial report and are available for public access on relevant websites. The company, focused on developing therapeutics for chronic inflammatory diseases, continues to advance its lead drug candidate, obefazimod, currently in Phase 3 trials for ulcerative colitis.
Read more →ABVXAbivax Announces Full Year 2025 Financial Results and Provides Business Updates
Abivax SA announced its financial results for the full year 2025, reporting a solid cash position and positive developments in its Phase 3 clinical trials for obefazimod aimed at ulcerative colitis. The DSMB confirmed no new safety signals in ongoing trials, supporting the timeline for topline results expected in late Q2 2026. Additionally, the company appointed key leadership figures to bolster its strategic direction. Overall, while expenses related to R&D and G&A saw notable increases, the company's financial foundation appears robust for its upcoming projects.
Read more →ABVXAbivax Presents First Evidence of Anti-Fibrotic Activity for Obefazimod Alongside New Clinical Efficacy and Safety Analyses in Inflammatory Bowel Disease at ECCO 2026
Abivax presented new data at ECCO 2026, showcasing obefazimod's anti-fibrotic activity and its efficacy and safety in treating inflammatory bowel disease. The findings suggest that obefazimod may offer significant benefits for patients with Crohn's disease and ulcerative colitis. The company anticipates upcoming Phase 3 and Phase 2b trial results in 2026.
Read more →ABVX▲ +6.2%on this news
Abivax Provides 2026 Corporate Outlook
Abivax has provided its corporate outlook for 2026, emphasizing the promising prospects for its lead drug obefazimod in treating ulcerative colitis and Crohn's disease. The company reported no safety concerns from the recent Phase 3 trial, with results from the maintenance trial expected by late Q2 2026. There are also plans for a New Drug Application filing by the end of 2026 as market research suggests obefazimod could dominate the UC landscape. Additionally, ongoing trials and presentations at the upcoming ECCO conference are expected to further affirm its therapeutic potential in chronic inflammatory conditions.
Read more →ABVXAbivax to be Added to Nasdaq Biotechnology Index
Abivax SA has announced that it will be added to the Nasdaq Biotechnology Index, effective December 22, 2025. This inclusion is viewed as a significant achievement for the company, reflecting its progress with the drug obefazimod in clinical trials for ulcerative colitis. The Nasdaq Biotechnology Index tracks the performance of biotech and pharmaceutical companies and requires adherence to specific criteria. The announcement aims to enhance Abivax's visibility in the global biotech landscape.
Read more →ABVXAbivax Announces Acceptance of 22 Abstracts Evaluating Obefazimod in Inflammatory Bowel Disease at ECCO 2026, Featuring an Oral Presentation on Preclinical Anti-Fibrotic Findings
Abivax announced that 22 abstracts on obefazimod for inflammatory bowel disease will be presented at ECCO 2026. The data includes subgroup analyses from Phase 3 trials, showcasing obefazimod's clinical efficacy and tolerability. An oral presentation will highlight its anti-fibrotic properties, addressing a significant unmet need in IBD treatment.
Read more →ABVX▼ -6.1%on this newsshared move
Abivax Presents Third Quarter 2025 Financial Results
Abivax has reported its financial results for the third quarter of 2025, showing a significant operating loss of EUR 174.4 million, up from EUR 130.2 million in 2024. The company has increased its research and development expenditure, primarily due to ongoing clinical trials for ulcerative colitis and Crohn's disease. Despite a strong cash position of EUR 589.7 million providing a runway into Q4 2027, the company is facing challenges with rising expenses and a substantial net loss of EUR 254.1 million for the nine months ended September 30, 2025.
Read more →ABVXAbivax Announces Patient-Reported Outcomes Data from the Phase 3 ABTECT Induction Trials of Obefazimod, Demonstrating Significant Improvements in Quality of Life for Patients with Moderate-to-Severely Active Ulcerative Colitis
Abivax has announced positive patient-reported outcomes from its Phase 3 ABTECT trials for obefazimod, indicating significant improvements in the quality of life for patients with moderate-to-severely active ulcerative colitis. The results underscore the importance of quality of life measures alongside clinical efficacy. The company plans to present detailed findings at an upcoming medical conference.
Read more →ABVXAbivax Announces Late-Breaking Presentation of 8-Week ABTECT Induction Trial Results in Participants With and Without Prior Inadequate Response to Advanced Therapies
Abivax presented positive results from its Phase 3 ABTECT trial for obefazimod at the UEG Meeting. The data showed clinically meaningful improvements in patients with moderate-to-severely active ulcerative colitis, including those with prior inadequate responses to advanced therapies. The treatment demonstrated a favorable safety profile and efficacy across various patient subgroups.
Read more →ABVXAbivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data
Abivax announced positive results from its Phase 3 ABTECT trials for obefazimod, showing significant clinical remission rates in patients with moderate-to-severely active ulcerative colitis. The trials reported no serious adverse events, with the most common side effects being mild headaches and nausea. An investor call is scheduled to discuss these findings further.
Read more →ABVXAbivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting
Abivax announced the acceptance of a second late-breaking abstract for obefazimod, its lead drug candidate, at the upcoming United European Gastroenterology Congress in 2025. The ABTECT Phase 3 trial results indicate significant clinical activity and a favorable safety profile for treating moderately to severely active ulcerative colitis. This development is a crucial step towards providing new therapeutic options for patients.
Read more →ABVXAbivax Announces Presentation of Late-Breaking Abstract for Obefazimod from the ABTECT Phase 3 Induction Trials at 2025 United European Gastroenterology (UEG) Meeting
Abivax announced the presentation of a late-breaking abstract for obefazimod at the upcoming UEG Congress in Berlin. This presentation will focus on findings from the ABTECT Phase 3 induction trials, which aim to establish the drug's efficacy for treating moderately to severely active ulcerative colitis. The company expresses optimism about obefazimod's potential as a therapeutic option.
Read more →ABVXAbivax to Join CAC Mid 60 and SBF 120 Indices Following Euronext Paris Annual Review
Abivax has been admitted to the CAC Mid 60 and SBF 120 indices following the annual review by Euronext Paris. This inclusion is set to take effect on September 19, 2025, and is anticipated to enhance the visibility of Abivax, making its shares more accessible to a wider array of institutional investors and index-linked funds. CEO Marc de Garidel expressed that this achievement underscores the financial markets' confidence in the company's strategies and contributes to its commitment to developing innovative therapies for chronic inflammatory diseases.
Read more →ABVXAbivax Presents First Half 2025 Financial Results
Abivax SA has reported its financial results for the first half of 2025, revealing a solid cash position and successful funding efforts. The company anticipates that its financial resources will sustain operations until late 2027. Abivax is focused on developing therapies for chronic inflammatory diseases, with its lead candidate currently in Phase 3 trials.
Read more →ABVXAbivax Announces Closing of $747.5 Million Public Offering
Abivax SA has successfully closed its public offering, raising $747.5 million through the sale of American Depositary Shares. The company anticipates that the net proceeds will provide sufficient funding to support its operations until the fourth quarter of 2027. This includes preparatory steps for the planned New Drug Application submission for its lead product, obefazimod, following positive outcomes in its Phase 3 trial for ulcerative colitis. The offering indicates strong investor confidence and positions the company favorably in its clinical development strategy.
Read more →ABVXAbivax Announces Full Exercise of Underwriters’ Option to Purchase Additional ADSs, Bringing Gross Proceeds of Offering to $747.5M (€637.5M)
Abivax SA announced the full exercise of the underwriters' option to purchase an additional 1,523,400 American Depositary Shares (ADSs), bringing total gross proceeds from the offering to about $747.5 million. The offering involved 10,156,000 ADSs and is set to close on July 28, 2025. The net proceeds after expenses are estimated to be around $700.3 million, which will be employed for the intended purposes outlined in the original offering. The ADSs are listed on the Nasdaq Global Market under the ticker ABVX.
Read more →ABVXAbivax announces trading resumption of its ordinary shares on Euronext Paris
Abivax announced the resumption of trading of its ordinary shares on Euronext Paris, effective from 3:30 p.m. CEST on July 24, 2025. The trading halt was initiated at the company's request to facilitate a public offering of American Depositary Shares. Abivax is currently focused on developing therapeutics for chronic inflammatory diseases, with its lead candidate, obefazimod, in Phase 3 trials for ulcerative colitis.
Read more →ABVXAbivax Announces Pricing of $650M (€554M) Public Offering of American Depositary Shares
Abivax SA has announced the pricing of a $650 million public offering of American Depositary Shares, which is expected to close on July 28, 2025. Each ADS represents one ordinary share priced at $64.00, reflecting a premium over recent market prices. The company aims to utilize the proceeds primarily for the clinical development of obefazimod to treat ulcerative colitis and Crohn's disease, as well as for general corporate purposes. However, shareholders may face dilution of their stakes due to the increase in share capital resulting from this offering.
Read more →ABVXAbivax announces temporary trading halt of its ordinary shares on Euronext Paris
Abivax SA has announced a temporary trading halt of its ordinary shares on Euronext Paris at the company's request. The halt is related to the public offering of American Depositary Shares in the United States and is intended to allow confirmation of investor allocations and pricing. Trading is expected to resume on the same day at approximately 3:30 p.m. CEST. Abivax is a biotechnology company focused on therapeutics for chronic inflammatory diseases, with its lead drug candidate, obefazimod, in Phase 3 trials for ulcerative colitis.
Read more →ABVX▲ +586%on this news· ran to +598% by day 1shared move
Abivax Announces Launch of Public Offering
Abivax has announced the launch of a public offering aimed at raising approximately $400 million by selling American Depositary Shares (ADSs). The company plans to use the proceeds primarily for developing its drug obefazimod to treat Ulcerative Colitis and Crohn's Disease, while also supporting general corporate purposes. The offering is subject to market conditions, and the final terms will be established through a book-building process. It is important for potential investors to consider the associated risks outlined in the company's preliminary prospectus.
Read more →ABVXAbivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis 50 mg once-daily do
Abivax reported successful topline results from its Phase 3 ABTECT-1 and ABTECT-2 trials evaluating obefazimod in patients with moderately to severely active ulcerative colitis. The trials demonstrated that the drug met the FDA's primary endpoint of clinical remission while showing a favorable safety profile. The company plans to submit a New Drug Application to the FDA in the second half of 2026, pending the results of a 44-week maintenance trial. Abivax's Chief Executive highlighted the importance of these results for the ulcerative colitis community.
Read more →ABVX▼ -5.7%on this news
Abivax Announces Results of its June 6, 2025 Annual General Meeting
Abivax SA held its annual general meeting on June 6, 2025, where shareholders approved all resolutions proposed by the Board. These included financial statements for the 2024 fiscal year and the compensation policies for top executives. Additionally, the meeting saw the ratification of Sylvie Grégoire as Chairman and the appointment of a new board member, Dominik Höchli. Further details regarding the votes will be made available on the company's website.
Read more →ABVXAbivax Announces Results of its
Abivax held its annual general meeting of shareholders on June 6, 2025, where all proposed resolutions by the Board were approved. This included the adoption of financial statements for the 2024 financial year and the approval of compensation policies for key executives. In addition, the shareholders ratified the appointment of Sylvie Gr goire as Chairman and Dominik H chli, MD as a member of the Board. Detailed voting results can be found on the company's website.
Read more →ABVX▲ +5.5%on this news· ran to +35% by day 3
Abivax Presents First Quarter 2025 Financial Results
Abivax SA announced its financial results for the first quarter of 2025, revealing a net loss of EUR 52.4 million, up from EUR 42.9 million in 2024. The company reported an increase in research and development expenses, particularly related to its Crohn’s Disease clinical program, which rose significantly. Despite achieving operational milestones, including the completion of Phase 3 trial enrollment for ulcerative colitis, the rising financial losses and decreased cash reserves highlight challenges ahead. The company expects to manage its operations into the fourth quarter of 2025 based on its current cash flow projections.
Read more →ABVXAbivax Announces Completion of Enrollment for the Phase 3 ABTECT Trials in Patients with Moderately to Severely Active Ulcerative Colitis
Abivax has completed enrollment for its Phase 3 ABTECT trials, involving 1,275 participants with moderately to severely active ulcerative colitis, surpassing the target set at 1,224. The company anticipates releasing top-line results from the induction trials in Q3 2025, followed by maintenance data in Q2 2026. If results are favorable, a New Drug Application (NDA) with the FDA is expected in the second half of 2026. The trial's participant characteristics align closely with past trials, boosting confidence in the program's potential success.
Read more →ABVXTrial Participant Baseline Characteristics ABTECT Phase 3 vs. Obefazimod Phase 2b Trial Participant Baseline Characteristics ABTECT Phase 3 vs. Obefazimod Phase 2b ABTECT Phase 3 Phase 2b Study Participants 1,275 252 Bas
Abivax has announced the successful completion of enrollment for its Phase 3 ABTECT trials, aimed at treating moderately to severely active ulcerative colitis, with 1,275 participants enrolled. This achievement exceeds the initial target of 1,224 participants. The company anticipates top-line results from the induction trials in Q3 2025 and plans to submit a New Drug Application if the results are favorable. The consistency in participant characteristics with prior trials adds to the confidence in the potential efficacy and safety of obefazimod.
Read more →ABVXAbivax Announces Annual General Meeting Details as Company Advances Toward Key 2025 Value-Driving Milestones Annual General Meeting scheduled for Friday
Abivax SA has announced details for its upcoming Annual General Meeting, scheduled for June 6, 2025, as it moves towards significant operational milestones in 2025. The company is actively engaged in its Phase 3 ABTECT clinical program, with a goal to complete induction trials enrollment by the second quarter of 2025 and to present topline data by the third quarter. The CEO emphasized a strong commitment to the company's future, as evidenced by a substantial investment in shares from the executive team, underpinning their confidence in the upcoming milestones.
Read more →ABVXAbivax publishes financial reports with the French and U.S. securities regulatory agencies
Abivax SA announced the filing of its Universal Registration Document with the French AMF and its Annual Report (20-F) with the U.S. SEC. This marks a significant compliance step for the clinical-stage biotechnology company. The Universal Registration Document includes key financial reports and management commentary. Abivax's lead candidate, obefazimod, is currently in Phase 3 trials aimed at treating moderately to severely active ulcerative colitis.
Read more →ABVXAbivax Announces Full Year 2024 Financial Results
Abivax reported its financial results for 2024, highlighting a cash balance of EUR 144.2 million, allowing for operations into Q4 2025. The company anticipates completing enrollment for its Phase 3 ABTECT trial for ulcerative colitis in Q2 2025, with expected top-line results in Q3 2025. However, the company faced significant operating losses and increased expenditures in R&D, which prompted caution regarding its financial health and operational sustainability.
Read more →ABVX▲ +6%on this news
Abivax to Host Key Opinion Leader (KOL) Webcast on March 17, 2025
Abivax has announced it will host a Key Opinion Leader (KOL) webcast on March 17, 2025, featuring Dr. David T. Rubin, a leading gastroenterologist. The event will focus on the treatment landscape for ulcerative colitis and details regarding Abivax's ABTECT Phase 3 trial of obefazimod. Participants will have the chance to engage in a live Q&A session with both Dr. Rubin and Abivax's management, emphasizing the company's commitment to addressing unmet needs in chronic inflammatory diseases.
Read more →ABVXAbivax Publishes 2025 Financial Calendar
Abivax SA has published its expected financial communications calendar for 2025, detailing key reporting dates including annual and quarterly results. The calendar highlights Abivax's commitment to transparency in its financial operations, with specific dates for the Annual General Meeting and financial result releases. The company continues to focus on developing innovative therapies for chronic inflammatory diseases, with its lead drug candidate, obefazimod, currently in Phase 3 trials for ulcerative colitis.
Read more →ABVXAbivax Announces Presentation of Seven Abstracts for Obefazimod in Ulcerative Colitis at 2025 European Crohn’s and Colitis Organization 20th Annual Congress
Abivax SA announced the acceptance of seven scientific abstracts regarding their lead drug candidate, obefazimod, for ulcerative colitis at the upcoming ECCO Congress. The congress will take place from February 19-22, 2025, in Berlin, Germany. The abstracts are expected to highlight the drug's efficacy and safety in treating moderately to severely active ulcerative colitis, reflecting ongoing clinical research and engagement within the medical community. This development underscores Abivax's commitment to advancing therapeutic options for chronic inflammatory diseases.
Read more →ABVXAbivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment Phase 3 ABTECT Trial evaluating obefazimod for moderately to severely active ulcerative colitis ( UC ) reaches 1,003 of 1,224 participants, representing 82
Abivax SA announced a major milestone in its Phase 3 ABTECT trial for obefazimod, having enrolled over 1,000 participants, which is 82% of the target. The trial is noted for its rapid recruitment rate, demonstrating strong enthusiasm among participants and investigators. The company expects to conclude enrollment by Q2 2025 and provide top-line results for the induction trial in Q3 2025. Additionally, Abivax has confirmed that its financial resources are sufficient to support operations through and beyond critical readout results.
Read more →ABVXAbivax Announces a Change to the Composition of its Board of Directors
Abivax SA announced a change in its board of directors, with Dr. Philippe Pouletty resigning effective December 31, 2024, due to his new role as Chairman and acting CEO of another biotech company. Dr. Pouletty has been instrumental in the company since its inception and has contributed significantly to the development of its lead drug candidate, obefazimod. Abivax will now seek a new board member to support its clinical-stage pipeline, particularly as it progresses toward a critical data readout in 2025.
Read more →ABVXAbivax Establishes an At-the-Market (ATM) Program on Nasdaq
Abivax SA has announced the initiation of an At-The-Market (ATM) program on Nasdaq, allowing for the sale of American Depositary Shares (ADSs) worth up to $150 million. This program is intended to provide funding primarily for the company's clinical programs, including obefazimod. The ATM program is effective for three years, subject to regulatory and market conditions. Abivax has also filed a shelf registration statement with the SEC for additional sales opportunities related to its securities.
Read more →ABVXAbivax presents third quarter 2024 key financial information
Abivax SA presented its financial results for the third quarter of 2024, highlighting a cash balance of EUR 180.5 million which allows for operational funding until Q4 2025. The company detailed its ongoing progress in clinical trials, particularly in Ulcerative Colitis and Crohn’s Disease treatments. Despite these positive developments, Abivax holds a total principal debt of EUR 106.3 million and cautioned investors regarding the uncertainties associated with clinical and regulatory challenges.
Read more →ABVXAbivax Announces Former Prometheus COO, Mark Stenhouse, Appointed as Board Observer & Advisor to Abivax
Abivax has appointed Mark Stenhouse, former COO of Prometheus Biosciences, as Board Observer and Advisor. Stenhouse brings over 30 years of biopharma experience, which is expected to enhance Abivax's strategic direction, particularly for its candidate obefazimod. The company is moving towards commercialization after positive Phase 2 results for obefazimod in ulcerative colitis, with further trials planned. Stenhouse has expressed confidence in the drug's potential to meet significant medical needs.
Read more →ABVXAbivax Congratulates Victor Ambros and Gary Ruvkun on Their Nobel Prize for the Discovery of microRNA and its Role in Post-Transcriptional Gene Regulation
Abivax SA congratulated Victor Ambros and Gary Ruvkun for winning the Nobel Prize in Physiology or Medicine for their groundbreaking work on microRNA. The company's CEO highlighted the significance of microRNA research and expressed pride in Abivax's ongoing clinical programs, particularly for their lead candidate obefazimod, which is under evaluation for ulcerative colitis and Crohn's disease. Abivax aims to leverage the discoveries in microRNA to enhance their therapeutic approaches for chronic inflammatory diseases.
Read more →ABVXAbivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease
Abivax has announced the enrollment of the first patient in its Phase 2b ENHANCE-CD trial, which will evaluate obefazimod for treating Crohn's disease. This multicenter, double-blind study aims to assess the efficacy and safety of the drug, providing hope for patients with inadequately treated conditions. The trial is structured into three phases, aiming to offer a once-daily, convenient treatment option. The enrollment marks a significant milestone for Abivax as it seeks to address unmet medical needs in chronic inflammatory diseases.
Read more →ABVXAbivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance
Abivax has reported positive interim efficacy and safety results for obefazimod, a once-daily oral treatment for moderate to severe ulcerative colitis. After two years of open-label maintenance, patients on a reduced dose of 25mg showed sustained clinical remission. The treatment demonstrated a favorable safety profile and retained high patient retention rates. These findings support obefazimod's potential as a therapeutic option for ulcerative colitis patients.
Read more →ABVXAbivax to Present Three Abstracts for Obefazimod in Ulcerative Colitis at the UEG Week 2024
Abivax announced the presentation of three abstracts on its lead drug candidate, obefazimod, during the UEG Week 2024 in Vienna. Key highlights will include data from a Phase 2b trial examining the efficacy and safety of obefazimod in patients with moderately to severely active ulcerative colitis. The findings, particularly concerning corticosteroid-free efficacy and the impact on histological outcomes, are expected to contribute to advancing treatment options. Additionally, a Phase 2b trial for Crohn's disease is anticipated to begin in Q3 2024.
Read more →ABVXAbivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model
Abivax announced promising early preclinical data indicating that the combination of obefazimod and etrasimod may enhance treatment efficacy for ulcerative colitis (UC) in mouse models. The company aims to develop a fixed-dose combination therapy that maximizes efficacy while ensuring a solid safety profile, ultimately seeking to improve patient outcomes. Further preclinical studies will continue, with the selection of an optimal candidate anticipated in 2025. Abivax expects to share additional findings at an upcoming scientific conference.
Read more →ABVXAbivax presents first-half 2024 financial results
Abivax SA has reported its financial results for the first half of 2024, showing a significant cash balance of EUR 222M and a projected financial runway into Q4 2025. While the operating income increased to EUR 6.8M, the company recorded a notable rise in operating losses, totaling EUR -80M, primarily driven by increased research and development expenses. Additionally, the net loss for the period reached EUR -81.6M, indicating financial challenges alongside operational updates related to its clinical programs.
Read more →ABVXAbivax Announces ABTECT Phase 3 Trial Achieves Key Enrollment Milestone
Abivax has announced that its Phase 3 ABTECT Trial evaluating obefazimod for moderately to severely active ulcerative colitis has surpassed the 600-patient enrollment milestone. This achievement positions the trial to potentially reach full enrollment by early Q1 2025. The trial's baseline characteristics are consistent with trends observed in earlier Phase 2b trials, indicating a positive trajectory for the investigational drug candidate. Abivax aims to build on its progress with plans for a Phase 2b trial in Crohn's disease expected to start in Q3 2024.
Read more →ABVXAbivax Provides Operational and Key Program Update
Abivax has announced significant progress in its clinical programs, particularly with the Phase 3 ABTECT Trial evaluating obefazimod for ulcerative colitis, which is expected to complete enrollment by early Q1 2025. Preliminary top-line results from the trial are anticipated in early Q2 2025, with ongoing preclinical combination therapy programs also showing promise. Leadership changes include the appointment of Sylvie Grégoire as Chair of the Board and new executive positions filled by Dr. Fabio Cataldi and Dr. David Zhang. The company maintains a strong financial position with sufficient cash reserves to support its operations through critical upcoming trials.
Read more →ABVXAbivax releases the results of its May 30, 2024 Ordinary and Extraordinary General Meeting
Abivax SA held its Ordinary and Extraordinary General Meeting on May 30, 2024, where shareholders successfully adopted all proposed resolutions, including financial statements for 2023 and Board member appointments. The Company’s investigational drug Obefazimod has shown promise in Phase 2 trials, leading to the initiation of a Phase 3 clinical trial program. Looking ahead, a Phase 2b study in Crohn’s disease is planned for Q3 2024, with ongoing research into combination therapy opportunities. However, the company acknowledges substantial uncertainties regarding future clinical outcomes and necessary regulatory approvals.
Read more →ABVXAbivax releases the results of its
Abivax held its Ordinary and Extraordinary General Meeting on May 30, 2024, where shareholders approved all resolutions proposed by the Board, including financial statements for 2023. The company reaffirmed its focus on the investigational drug obefazimod, which has promising Phase 2 clinical trial results for ulcerative colitis. A pivotal Phase 3 trial is underway, with future trials in Crohn's disease anticipated. The meeting also saw the appointment of new Board members.
Read more →ABVXAbivax announces presentation of four abstracts for obefazimod in ulcerative colitis and preclinical colon cancer model at Digestive Disease Week 2024
Abivax SA has announced the acceptance of four scientific abstracts for its lead drug candidate, obefazimod, which will be presented at the Digestive Disease Week 2024 in Washington D.C. The presentations will focus on the treatment of moderately to severely active ulcerative colitis and the drug's impact in a preclinical model for colon cancer. Notably, new data will highlight obefazimod's efficacy in reducing tumors in a murine colitis-associated cancer model, supporting its innovative mechanism of action. Abivax plans to share further insights into the drug's clinical profiles and ongoing developmental programs during the event.
Read more →ABVXAbivax annual ordinary and extraordinary general meeting of May 30, 2024 - Availability of the preparatory documents
Abivax is holding its annual ordinary and extraordinary general meeting on May 30, 2024, in Paris. Shareholders can access preparatory documents and information related to the meeting via the company's website. The highlight of the meeting is the progress on Abivax's investigational drug candidate, obefazimod, which is advancing into pivotal trials and showcases encouraging developments in clinical studies for ulcerative colitis and upcoming trials in Crohn's disease.
Read more →ABVXAbivax reports 2023 financial results and operational update
Abivax SA has reported its 2023 financial results, announcing a successful EUR 500M fundraising that includes capital increases and a Nasdaq IPO. The company plans to use these funds to finance ongoing clinical trials, particularly the Phase 3 ABTECT trial for obefazimod in ulcerative colitis, expected to yield top-line data by Q4 2025. However, the company faces heightened operational losses and increasing R&D costs, reflecting the challenges associated with expanding its drug development programs. The leadership aims to build on its achievements as it strengthens its operational infrastructure in both the U.S. and European markets.
Read more →ABVXAbivax appoints Ana Sharma as Vice President, Global Head of Quality
Abivax has appointed Ana Sharma as the new Vice President and Global Head of Quality. With over 20 years in the biopharmaceutical sector, Sharma's extensive experience in quality assurance is expected to benefit Abivax, particularly in the execution of the Phase 3 ABTECT clinical program. She aims to ensure that the lead drug candidate, obefazimod, meets GxP quality standards as it moves toward potential market availability. CEO Marc de Garidel expressed confidence in Sharma's ability to contribute positively to the company's strategic goals.
Read more →ABVXAbivax announces update to obefazimod Phase 2b clinical development program in moderately to severely active Crohn’s disease
Abivax has announced an update regarding its obefazimod Phase 2b clinical trial program for moderately to severely active Crohn's disease. The company received FDA clearance to proceed with the Investigational New Drug (IND) application and is set to start patient enrollment in Q3 2024. The revised trial design reflects FDA recommendations and aims for a more efficient path towards a supplemental New Drug Application submission. Initial data from the trial is anticipated to be available in the second half of 2026.
Read more →ABVXAbivax to host KOL Investor Event to review phase 2b clinical data and phase 3 trial design for obefazimod in patients with moderately to severely active ulcerative colitis on February 6, 2024
Abivax SA has announced a virtual KOL Investor Event scheduled for February 6, 2024, to review clinical data from the Phase 2b trial and the Phase 3 trial design for its lead drug candidate, obefazimod, aimed at treating moderately to severely active ulcerative colitis. The event will include presentations by Dr. Marla Dubinsky and Dr. Parambir Dulai, who will address the current treatment landscape and unmet medical needs in ulcerative colitis. Additionally, discussions will cover obefazimod's mechanism of action and its development plans, followed by a live Q&A session.
Read more →ABVXAbivax provides 2024 strategic outlook and lays out key milestones over next 12 months
Abivax has outlined its strategic priorities for 2024, focusing on the development of obefazimod for ulcerative colitis and Crohn's disease. Key milestones include top-line data read-outs expected in 2024 and 2025 from pivotal Phase 3 trials. The company has secured financing through a successful IPO, allowing it to pursue its ambitious trial objectives. Recruitment for the induction trials is ongoing, and formal evaluations of combination therapies are underway, aimed at enhancing its product pipeline.
Read more →ABVXAbivax 2024 Financial Communication Calendar
Abivax has announced its financial communication calendar for 2024, which includes key dates for shareholder meetings and financial reports. The calendar outlines specific reporting dates, including the Annual Business and Financial Report on April 2, the Half-Year Business and Financial Report on September 9, and financial information for the third quarter on November 7. The company emphasizes the forward-looking nature of the statements made in the release, highlighting potential uncertainties that could impact future results.
Read more →ABVXAbivax announces the resumption of its liquidity contract
Abivax SA has announced the resumption of its liquidity contract effective November 21, 2023, after the end of a stabilization period that commenced following its recent IPO. The liquidity contract, originally established in 2015, was temporarily suspended during the IPO on the Nasdaq Global Market. As of the resumption, Abivax has allocated over 11,000 shares to its liquidity account for contract fulfillment. This move highlights the company's effort to manage its share liquidity effectively post-IPO.
Read more →ABVXAbivax to participate in the Piper Sandler 35th Annual Healthcare Conference
Abivax SA has announced its participation in the Piper Sandler 35th Annual Healthcare Conference, set to take place in New York from November 28-30, 2023. During the conference, the company's management will hold meetings with investors and deliver a corporate overview. This event allows Abivax to engage with potential investors and showcase its focus on developing therapeutics for chronic inflammatory diseases. A live webcast of the presentation will be available on their website, with a replay accessible for three months.
Read more →ABVXABIVAX to Host Key Opinion Leader Luncheon for Investors Focused on Novel Approaches to HIV Therapy
PARIS, Nov. 22, 2016 (GLOBE NEWSWIRE) -- ABIVAX (Euronext Paris: FR0012333284 – ABVX), an innovative biotechnology company targeting the immune system to eliminate viral disease, today announced that it will host a Key Opinion Leader luncheon for investors focused on novel approa
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