Late-breaking data from EASL reinforces IQIRVO’s impact on ALP reduction with fatigue and pruritus improvement in patients with PBC

• Three late-breaking abstracts accepted, including:
  • Real-world benefit of IQIRVO^® (elafibranor) in PBC patients with Alkaline Phosphatase (ALP) 1-1.67 x Upper Limit of Normal (ULN) and on fatigue and pruritus symptoms
  • ELATIVE Phase III trial data on the impact of IQIRVO on PBC fatigue

PARIS, FRANCE, 15 MAY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today the latest data on IQIRVO^® (elafibranor) demonstrating clinically meaningful improvements in ALP, a surrogate marker of primary biliary cholangitis (PBC) disease progression, and symptom management, achieved in a real-world setting, will be presented at the European Association for the Study of Liver Disease (EASL) 2026 congress in Barcelona. IQIRVO is the only PBC therapy with data on meaningful improvements on Alkaline Phosphatase (ALP) reduction and both fatigue and pruritus symptoms.

In a late-breaking presentation, the depth of effect of IQIRVO on ALP normalization in PBC patients with ALP 1-1.67 x upper limit of normal (ULN) in the real-world setting will be presented. Normalization of ALP levels (<1 x ULN) is associated with improved prognosis and increased survival rates. Ipsen is currently conducting a Phase III study, ELSPIRE, which is evaluating IQIRVO in this patient population, in a clinical setting.

Additionally, Ipsen will present interim real-world data from the ELFINITY^® Phase IV study confirming real-world effectiveness of IQIRVO in both biochemical outcomes and symptom control, including fatigue and pruritus, with a favorable safety profile.

Further late-breaking data includes a new post-hoc analysis from the Phase III pivotal ELATIVE^® trial, which will provide further evidence of the impact of IQIRVO on fatigue, using the established Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a (PROMIS PFSF 7a) tool. Fatigue is the most common and debilitating symptom reported by PBC patients. IQIRVO is the only medicine to have demonstrated a positive effect on fatigue in patients with moderate to severe fatigue at baseline and occurring independently of its effect on pruritus.¹

With two molecules approved for three different rare cholestatic liver diseases and a pipeline with two additional late-stage indications, Ipsen is leading research and development for treatments where unmet need is high and treatments are often few or do not exist.

Ipsen Abstracts

About IQIRVO^® (elafibranor)
IQIRVO is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist, which exerts an effect on PPARα and PPARδ. Activation of PPARα and PPARδ decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways. In 2019, Iqirvo was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. Iqirvo was granted U.S. FDA accelerated approval in June 2024, conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA, EMA and MHRA approvals are contingent on the further verification of clinical benefit. Iqirvo is currently in regulatory processes with other authorities. Iqirvo (elafibranor) was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021 and expanded the geographical scope to China, Hong Kong, Taiwan and Macau in March 2026.

About Primary Biliary Cholangitis 
PBC is a rare, autoimmune liver disease where a build-up of bile and toxins and chronic inflammation cause irreversible fibrosis of the liver and destruction of the bile ducts. Impacting approximately 100,000 people in the US and 165,000 people in Europe, the majority being women, PBC is a lifelong condition that can worsen over time if not effectively treated and may lead to liver transplant and in some cases, premature death. 

About Ipsen
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

Disclaimers and/or forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com.

References

1. Jones. D. et al. Clinically significant improvements in fatigue with elafibranor in patients with primary biliary cholangitis and limited association with pruritus: Analyses from the phase III ELATIVE.^® European Association for the Study of the Liver (EASL) congress, 2025. Abstract LB25220 

Attachment

• Ipsen PR_EASL_15052026