GENFIT: Positive Phase 1b Data with GNS561 in Combination Therapy in Heavily Pretreated Patients with Cholangiocarcinoma

GENFIT announced positive Phase 1b results for GNS561, an investigational drug targeting autophagy, in combination with a MEK inhibitor for treating advanced KRAS-mutated cholangiocarcinoma. The study of 19 patients showed a favorable safety profile with no dose-limiting toxicities and early signs of antitumor activity, with approximately half achieving stable disease. Phase 2 initiation is planned for the second half of 2026.

06/23/2026, 12:00 PM • GlobeNewswire

GENFIT : Données positives de Phase 1b obtenues avec GNS561 en combinaison, dans une population de patients atteints de cholangiocarcinome lourdement prétraités

GENFIT reported positive Phase 1b results for GNS561 combined with a MEK inhibitor in heavily pretreated cholangiocarcinoma patients with KRAS mutations. The drug demonstrated favorable safety and tolerability profiles with no dose-limiting toxicities, along with early signs of antitumor activity. Approximately half of the 19 patients achieved stable disease at Week 6, with one patient maintaining this status through Week 30. The company plans to extend Phase 1b with additional cohorts at higher doses and proceed to Phase 2 launch in H2 2026.

06/23/2026, 12:00 PM • GlobeNewswire

IPSEN - Buy-back programme - Art 5 of MAR - Week 25 - 2026

Ipsen conducted share buy-backs during the week of June 15-19, 2026, purchasing a total of 28,105 shares at a weighted average price of €156.21 per share on the Euronext Paris exchange. This represents part of the company's ongoing buy-back programme under MAR Article 5 regulations.

06/22/2026, 12:00 PM • GlobeNewswire

IPSEN - Achats effectués dans les conditions de l'Article 5 du Règlement MAR - Semaine 25 - 2026

IPSEN executed a share buy-back programme from June 15-19, 2026, purchasing a total of 28,105 shares at a weighted average price of €156.21 per share on the Euronext Paris exchange. The daily volumes ranged from 1,743 to 9,931 shares, with prices fluctuating between €155.47 and €157.21.

06/22/2026, 12:00 PM • GlobeNewswire

De nouvelles données "late-breaking" renforcent l’impact d’IQIRVO® sur l’ALP, la fatigue et le prurit dans la CBP.

Ipsen presented new clinical data on IQIRVO (elafibranor) at the EASL congress, demonstrating significant improvements in alkaline phosphatase (ALP) reduction, fatigue, and pruritus in primary biliary cholangitis (PBC) patients. Real-world data showed 59% of patients achieved ALP normalization at 6 months, while 67% of patients with moderate-to-severe fatigue showed clinically significant improvements compared to 31% on placebo at 52 weeks.

05/28/2026, 1:30 AM • GlobeNewswire

New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in PBC

Ipsen announced late-breaking results from the ELATIVE Phase III trial and real-world studies showing IQIRVO (elafibranor) demonstrated clinically meaningful improvements in fatigue, with 67% of patients achieving improvement versus 31% on placebo at Week 52. Real-world data showed 59% of patients achieved ALP normalization at 6 months, and the Phase IV ELFINITY study confirmed rapid ALP reductions and favorable tolerability in routine clinical practice.

05/28/2026, 1:30 AM • GlobeNewswire

Ipsen announces late-breaking data from first head-to-head study comparing Dysport® and Botox® in adults with upper limb spasticity

Ipsen announced results from the DIRECTION trial, the first prospective head-to-head Phase IV study comparing Dysport (abobotulinumtoxinA) to Botox (onabotulinumtoxinA) in adults with upper limb spasticity. The trial met its primary and secondary endpoints, showing Dysport had a non-inferior safety profile to Botox while achieving longer-lasting symptom control (14.2 vs 13.8 weeks). Results will be presented at the ISPRM congress in Vancouver on May 19, 2026.

05/19/2026, 3:00 PM • GlobeNewswire

Ipsen annonce des données « late-breaking » issues de la première étude comparative directe entre Dysport® et Botox® chez des adultes atteints de spasticité du membre supérieur

Ipsen announced results from the DIRECTION study, the first direct head-to-head comparison of Dysport (abobotulinumtoxinA) and Botox (onabotulinumtoxinA) in adults with upper limb spasticity. The study met its primary safety endpoint, showing Dysport's safety profile is non-inferior to Botox, and achieved its secondary efficacy endpoint, demonstrating Dysport provides longer-lasting symptom control (14.2 vs 13.8 weeks). Results will be presented at the ISPRM World Congress in Vancouver on May 19, 2026.

05/19/2026, 3:00 PM • GlobeNewswire

Ipsen présente les derniers résultats d'une étude de phase II sur la corabotase, première de sa classe, concernant les rides glabellaires, montrant une durée d'effet prolongée et un niveau de satisfaction constamment élevé chez les patients

Ipsen announced Phase II trial results for corabotase (IPN10200), a first-in-class recombinant neuroinhibitor (RNITM), showing rapid onset (0.84 days) and sustained efficacy for glabellar wrinkles. At week 24, 60.8% of patients treated with corabotase (50 ng) achieved clinically significant sustained effect compared to 0.2% placebo and 36.7% Dysport, with 82.8% patient satisfaction. The 50 ng dose has been selected for Phase III LAURITE trials, with additional data expected for forehead and crow's feet indications.

05/16/2026, 8:00 AM • GlobeNewswire

Ipsen presents first-in-class late-breaking Phase II corabotase data in glabellar lines showing sustained duration of effect reinforced by consistently high patient satisfaction

Ipsen announced Phase II trial results for corabotase, a first-in-class recombinant neuroinhibitor (RNITM), for treating moderate-to-severe glabellar lines. The drug demonstrated rapid onset (0.84 days), superior efficacy compared to placebo and Dysport at Week 24 (60.8% sustained clinical effect), and high patient satisfaction (82.8%). The 50ng dose was selected for Phase III LAURITE trials, with additional proof-of-concept data expected for forehead and lateral canthal lines.

05/16/2026, 8:00 AM • GlobeNewswire

DYSPORT Sales Forecast and Market Size Analysis Report 2026-2034 with Focus on United States, Germany, France, Italy, Spain, United Kingdom, and Japan

A comprehensive market analysis report on Dysport (Ipsen's botulinum toxin type A) projects strong growth through 2034, driven by expanding neuromodulator and aesthetic injectable markets expected to reach $11.3B by 2028. Dysport holds 12% market share against Botox's 72%, leveraging competitive pricing and expanding therapeutic applications in neurological conditions. The report covers seven major markets including the US, EU4, UK, and Japan.

05/15/2026, 4:24 AM • GlobeNewswire

Ipsen unveils corabotase, a first-in-class recombinant neuroinhibitor, RNI™, at the SCALE Symposium

Ipsen announced positive Phase II data from the LANTIC trial for corabotase, the first molecule in a newly designated recombinant neuroinhibitor (RNITM) class recognized by WHO and USAN. The investigational treatment demonstrated rapid onset of action and sustained duration in treating glabellar lines, with proof-of-concept data expected for forehead and lateral canthal lines later in 2026. The company is advancing a broad Phase II and Phase III clinical program across multiple aesthetic and therapeutic indications.

05/14/2026, 1:30 AM • GlobeNewswire

Ipsen présente la corabotase, un neuro-inhibiteur recombinant (RNI™) « premier de sa classe », lors du symposium SCALE

Ipsen announced the presentation of Phase II trial data for corabotase (IPN10200), a first-in-class recombinant neuro-inhibitor (RNI™), for treating glabellar wrinkles at the SCALE 2026 symposium on May 16, 2026. The molecule, engineered with advanced protein technology, demonstrated rapid onset and sustained clinical effect. Corabotase is being evaluated across multiple aesthetic and therapeutic indications with Phase II and Phase III trials underway.

05/14/2026, 1:30 AM • GlobeNewswire

GENFIT : Publication du rapport de performance extra-financière 2026 (exercice 2025)

GENFIT published its 2025 extra-financial performance report, highlighting the implementation of its ESG roadmap with approximately 30 initiatives. The company achieved B Corp certification in 2025 and demonstrated strong employee engagement (90% survey participation) and maintained high gender equality index (88). Key achievements include mobilizing the medical and scientific ecosystem around ACLF as a strategic priority and securing local partnerships for healthcare innovation projects.

04/20/2026, 12:00 PM • GlobeNewswire

GENFIT: Publication of the 2026 Extra-Financial Report (fiscal year 2025)

GENFIT published its 2025 extra-financial performance report, highlighting the implementation of its ESG roadmap with approximately 30 initiatives across the company. The biopharmaceutical firm achieved B Corp certification in 2025 and demonstrated strong employee engagement with 90% survey participation. Key achievements include positioning Acute on-chronic Liver Failure (ACLF) as a strategic priority through international collaboration and maintaining a high gender equality index of 88. The company continues to focus on developing therapies for rare liver diseases while expanding its diagnostic franchise.

04/20/2026, 12:00 PM • GlobeNewswire