Articles from Abivax

Abivax Publishes 2025 Financial Calendar

Abivax Announces Presentation of Seven Abstracts for Obefazimod in Ulcerative Colitis at 2025 European Crohn’s and Colitis Organization 20th Annual Congress

Abivax Achieves Key Milestone in Phase 3 ABTECT Trial Enrollment

Abivax Establishes an At-the-Market (ATM) Program on Nasdaq

Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease

Abivax to Present Three Abstracts for Obefazimod in Ulcerative Colitis at the UEG Week 2024

Abivax announces presentation of four abstracts for obefazimod in ulcerative colitis and preclinical colon cancer model at Digestive Disease Week 2024

Abivax annual ordinary and extraordinary general meeting of May 30, 2024

Abivax publishes financial reports with the French and U.S. securities regulatory agencies

Abivax reports 2023 financial results and operational update

Abivax appoints Ana Sharma as Vice President, Global Head of Quality

Abivax announces update to obefazimod Phase 2b clinical development program in moderately to severely active Crohn’s disease

Abivax 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 provides 2024 strategic outlook and lays out key milestones over next 12 months

Abivax 2024 Financial Communication Calendar

Abivax announces the resumption of its liquidity contract

PARIS, France, November 14, 2023, 2:00 p.m. CET – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the immune response in patients with chronic inflammatory diseases, today announced that management will be holding meetings with investors and presenting a corporate overview at the upcoming Piper Sandler 35th Annual Healthcare Conference taking place in New York on November 28-30, 2023.

Shareholders approved all proposed resolutions

PARIS, FRANCE / ACCESSWIRE / June 1, 2022 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, announces today that a scientific article on its phase 2a clinical study results for the treatment of moderate to severe active rheumatoid arthritis (RA) with obefazimod (ABX464) has been published in the renowned peer-reviewed journal "Annals of the Rheumatic Diseases (ARD)"[1]. Further, the abstract on these phase 2a data has been selected for a poster presentation at the Annual European Congress of Rheumatology, EULAR 2022. The presentation will be given by principal investigator Claire Daien, M.D., Ph.D., on Wednesday, June 1, 2022 at 8:40 p.m. CEST (2:40 p.m. EST - accessible for registered EULAR participants only).

PARIS, FRANCE / ACCESSWIRE / May 18, 2022 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, informs its shareholders that its ordinary and extraordinary general meeting will be held on June 9, 2022, at 10:00 a.m. (CEST), at the offices of Dechert (Paris) LLP, located at 32 rue de

Our newswire features a comprehensive, flat-fee Press Release service. Generate quality engagement with real-time analytics to improve visibility and expand your influence.

- Interim analysis demonstrates best-in-class clinical remission in 55.3% of 217 ulcerative colitis (UC) patients (full analysis set) after 48 weeks of once-daily oral 50mg ABX464 - Moreover, in the subgroup of patients who had at least a clinical response after the 8-week induction study (n=121), 65.3% achieved clinical remission during the first year of maintenance treatment (full analysis set) - Endoscopic improvement and endoscopic

- Feedback received from the US and European regulatory agencies, both supporting the advancement ABX464 into a phase 3 clinical program in ulcerative colitis (UC), final preparations for the launch of the program are ongoing - Primary endpoint met with excellent efficacy and safety results of once-daily oral ABX464 in a phase 2b induction study, confirmed by additional long-term data of phase 2a and 2b UC open-label maintenance trials -

- Out of the 40 patients who enrolled into the ABX464 maintenance study, 23 patients have now reached the first year of treatment and all achieved at least an ACR20 [1] , with 19 and 12 patients achieving ACR50 and ACR70 respectively - Long-term safety profile (50mg ABX464 once daily + MTX) favorable and consistent with previous observations - The induction and maintenance results support further clinical development of ABX464 in RA and

- Abivax will be hosting a Satellite Symposium on February 17, 2022, at 12:00-1:00 pm CET (6:00-7:00am ET) on ABX464's potential to address unmet medical needs for the treatment of ulcerative colitis (UC) - Presentations will be given by IBD key opinion leaders Prof. Bruce Sands, M.D., M.S. and Prof. William Sandborn, M.D. - The US and European regulatory agencies recently expressed their support to move ABX464 into a global pivotal phase 3

PARIS, FRANCE / ACCESSWIRE / January 25, 2022 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases and cancer, today publishes its 2022 financial communication calendar. - Wednesday, March 16, 2022 Publication of financial statements as of December 31, 2021 - Friday, April 15, 2022 Publication and release of

- ABX196 phase 1/2 study results for the treatment of hepatocellular carcinoma (HCC) were selected for a presentation at the ASCO Gastrointestinal Cancers Symposium 2022 - ABX196 at a maximum dose of 0.4µg was very well tolerated in combination with checkpoint inhibitor nivolumab - 10 heavily pre-treated patients were included in the dose escalation phase of which 5 (50%) experienced a clinical benefit during the treatment period - The

- The responses from the European Medicines Agency (EMA) within the scientific advice meeting support moving 25mg and 50mg ABX464 into a phase 3 clinical program in ulcerative colitis (UC) - Abivax to present at the virtual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022, at 12:00-12:40 pm ET (9:00-9:40 am PST and 6:00-6:40 pm CET) PARIS, FRANCE / ACCESSWIRE / January 13, 2022 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a

- Abivax's presentation at the virtual J.P. Morgan Healthcare Conference scheduled for Thursday, January 13, 2022, at 12:00-12:40 pm ET (9:00-9:40 am PST and 6:00-6:40 pm CET) - FDA end-of-phase-2 feedback received, raising no objections to proceeding ABX464 into - pivotal phase 3 testing in ulcerative colitis (UC) - Abivax is focusing its operational activities on the ABX464 phase 3 program in UC - ABX464 long-term efficacy results provide a

End-of-phase-2 response from the US regulatory agency (FDA) provides guidance and a path forward to advance ABX464 into a phase 3 clinical program in ulcerative colitis (UC) PARIS, FRANCE / ACCESSWIRE / December 1, 2021 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today

- ABX196 is Abivax's second compound in clinical development after lead drug-candidate ABX464 - ABX196 was well tolerated and demonstrated promising signals of clinical benefit in heavily pre-treated hepatocellular cancer patients - ABX196 phase 1/2 study results were selected for a presentation at the 2022 ASCO Gastrointestinal Cancers Symposium (ASCO GI Cancers Symposium) - Detailed data of the abstract submitted at the ASCO GI Cancers

- Impressive clinical remission in 58.4% (ITT) of 101 patients after 48 weeks of once-daily oral 50mg ABX464, showing both maintained as well as further improved efficacy - Favorable safety and tolerability profile continues to support ABX464 chronic use potential - Launch of global phase 3 program with ABX464 in ulcerative colitis in preparation, with end-of-Phase-2 US FDA meeting in Q4 2021 and EMA Scientific Advice in early Q1 2022 -

Principal investigator Prof. Séverine Vermeire, M.D., Ph.D, to present Abivax's late-breaking abstract on ABX464 phase 2b study results in ulcerative colitis (UC) October 4, 2021, at 10:42-10:54 am CEST Abivax will also be hosting a Live Industry Symposium on ABX464's potential to address medical needs in UC, presentations will be given by key opinion leaders Prof. Bruce Sands, M.D., M.S. and Prof. William Sandborn, M.D. October 4,

- In May and September, Abivax reported excellent efficacy and safety results of once daily oral ABX464 in a phase 2b induction study in ulcerative colitis (UC) after 8 and 16 weeks of treatment, primary and key secondary endpoints were met - Abivax also communicated additional maintenance data of ABX464 phase 2a and 2b trials that confirmed long-term efficacy and safety of 50mg once daily oral ABX464 in UC patients - In June, Abivax announced

- Excellent once-daily oral ABX464 efficacy and safety data in the phase 2b clinical trial in ulcerative colitis (UC) patients, previously reported at 8-weeks, are further improved at - 16-weeks - Additional analyses (incl. miR-124 levels, histopathology, quality of life, etc.) underpin the potential of ABX464 to become a safe short- and long-term efficient treatment option in UC - Novel and highly differentiated mechanism of action of ABX464

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved a phase 1 clinical trial to confirm ABX464's pharmacokinetic profile in Japanese subjects This phase 1 study is required to include Japan in Abivax's ABX464 global phase 3 program for the treatment of ulcerative colitis As part of Abivax's ABX464 late-stage development plan, three additional phase 1 studies are being conducted in healthy volunteers, all progressing

- EUR 60M reserved primary equity offering at minimum discount (3%) - EUR 25M convertible bonds priced at 6.00% coupon and 25% conversion premium - Proceeds to be primarily used for further advancement of ABX464 clinical programs in chronic inflammatory diseases, expanding the cash runway into Q2 2022 PARIS, FRANCE / ACCESSWIRE / July 23, 2021 / Abivax (Euronext Paris: FR0012333284 - ABVX) (the "Company"), a clinical-stage biotechnology

- Primary endpoint met with ABX464 demonstrating good safety and tolerability profile with 50mg once daily oral administration - A statistically significant difference (p < 0.03) was met on key efficacy endpoint ACR20 [1] in the PP [2] population with 60% of ABX464 patients dosed with 50mg reaching that endpoint versus 22% in the placebo group - Other key efficacy endpoints (ACR50, ACR70, DAS28-CRP [3] , CDAI [4] ) as well as biological

- Primary endpoint (statistically significant reduction of Modified Mayo Score[1]) was met with once-daily ABX464 (25mg, 50mg, 100mg) at week 8 in these 254 patients randomized, double-blind and placebo-controlled clinical trial (p<0.05, intent-to-treat population [ITT]) - Key secondary endpoints, including endoscopic improvement, clinical remission, clinical response and the reduction of fecal calprotectin showed significant

PARIS, FRANCE / ACCESSWIRE / May 24, 2021 / Abivax SA (Euronext Paris: FR0012333284 - ABVX) (the "Company"), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, announces today the suspension of the trading of its shares until the publication of the results of its phase 2b study for the treatment of ulcerative colitis with

PARIS, FRANCE / ACCESSWIRE / April 30, 2021 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, announces today the publication of its 2021 Universal Registration Document (Document d'Enregistrement Universel 2021), filed with the French Financial Market Authorities,

The Webinar takes place on Tuesday, April 20, 2021 at 7:30am EDT (1:30pm CEST) PARIS, FRANCE / ACCESSWIRE / April 19, 2021 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today announced that it will host a key opinion leader (KOL) webinar on ABX464 for the treatment of

- 16-weeks induction treatment with ABX464 in phase 2b clinical study in ulcerative colitis completed for the 254 patients enrolled, with reduction of Total Mayo Score after 8 weeks as primary endpoint - Top-line data of induction phase to become available in the second half of May 2021 - 48-weeks maintenance treatment with ABX464 in phase 2b clinical study in ulcerative colitis now fully enrolled, with top-line data to become