Randomized Interval Assessment Trial of Lu177-Dotatate Every 8 Versus Every 16 Weeks in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors (NETs) to Lower TOxicity

This is a randomized Phase II/late phase I de-escalation clinical trial with approved investigational medicinal products in new use condition, low intervention.
Disease under study Patients with unresectable or metastatic, slowly progressive, well-differentiated (Grade1 and Grade2), somatostatin receptor-positive midgut neuroendocrine tumors (GEP-NETs).
It is planned to randomize 166 patients with a histologically confirmed diagnosis of slowly progressive grade 1 or grade 2 advanced midgut neuroendocrine tumors (NETs) candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT). Patients are required to have SSTR+ disease, as evidenced on somatostatin receptor imaging. Patients will be randomized into two arms:
1. control arm: regimen 177Lu-Dotatate every 8 weeks (q8w)
2. experimental arm: regimen 177Lu-Dotatate every 16 weeks (q16w)
Research hypothesis: Less intensive somatostatin-receptor (SST) targeted radioligand therapy (RLT) (7.4 GBq/cycle 177Lu-Dotatate every 16 weeks x 4 cycles) is associated with less severe hematological toxicities and may mitigate the risk to develop therapy-related myeloid neoplasms (t-MN) with similar antitumor efficacy in slowly growing gastrointestinal grade 1-2 NETs.

Start Date12 Jun 2025

Sponsor / Collaborator

Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)

[+1]

NCT06807437

/ RecruitingPhase 3IIT

A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.

Start Date09 May 2025

Sponsor / Collaborator

SWOG

[+1]

CTIS2023-505884-35-00

/ RecruitingPhase 4IIT

Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with long-acting Somatostatin Analogues – ATSA trial

Start Date17 Jun 2024

Sponsor / Collaborator-

100 Clinical Results associated with Lanreotide Acetate

100 Translational Medicine associated with Lanreotide Acetate

100 Patents (Medical) associated with Lanreotide Acetate

1,367

Literatures (Medical) associated with Lanreotide Acetate

04 Feb 2026·EUROPEAN JOURNAL OF ENDOCRINOLOGY

Histological evidence of familial GH-PitNET associated with germline MAX mutation

Article

Author: Cane, Mathilde ; Charnay, Theo ; Bresson, Damien ; Cazabat, Laure ; Salle, Henri ; Raverot, Gérald ; Salle, Laurence ; Romanet, Pauline ; Buffet, Alexandre ; Villa, Chiara ; Mas, Robin

Abstract:

MAX is a tumor suppressor gene, with germline pathogenic variants predisposing primarily to pheochromocytomas and, uncertainly to pituitary neuroendocrine tumor (PitNET). We report the first molecularly confirmed case of a MAX-related growth hormone (GH)-PitNET. A 20-year-old woman presented with acute hemiparesis, hemianopsia, and recent acromegaloid changes. MRI showed a giant invasive PitNET with brainstem compression. Biochemical testing confirmed acromegaly. Despite multimodal therapy (lanreotide, cabergoline, two debulking surgeries), disease control was achieved only after pasireotide and adjuvant proton therapy. Histology confirmed a sparsely granulated somatotroph adenoma. Germline analysis identified a heterozygous MAX pathogenic variant c.97C>T, introducing a premature stop codon (p.Arg33Ter). Tumor analysis found loss of heterozygosity and absence of MAX protein expression. The same variant was found in her father, who had a smaller intrasellar macroadenoma causing acromegaly. This familial observation provides the functional evidence that MAX is a driver in GH-PitNET and a candidate gene for PitNET predisposition.

01 Feb 2026·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Structural determination of self-assembled aggregates formed by a therapeutic cyclical peptide and an ionic surfactant in aqueous solution

Article

Author: Hernández, Marcos López ; Högström, Yumi Kim ; Pedersen, Jan Skov ; Brunzell, Ellen ; Bergström, L Magnus

Amphiphilic compounds, such as phospholipids or surface-active substances, are present in biological systems and can be part of pharmaceutical formulations. As a consequence, all pharmaceutically active ingredients will encounter amphiphilic compounds, either in the formulation or after administration. With the growing interest in peptide-based pharmaceuticals, there is a need to enhance the understanding of the interactions between peptides and amphiphilic compounds. In this particular study, we have chosen to study mixtures of the comparatively small cyclical octapeptide lanreotide and the conventional anionic surfactant sodium dodecylsulfate (SDS). This was done by examining the self-assembly structures formed in lanreotide-SDS mixtures using light scattering and small-angle X-ray scattering (SAXS). Above the critical micelle concentration (cmc) of SDS, the large excess of SDS could solubilize all lanreotide and form small micelles with lanreotide attached to the interface. Upon dilution to concentrations below the cmc of SDS, a suspension with dispersed solid nanoparticles is formed. The solid nanoparticles grow in size with decreasing concentration and, eventually, precipitate. The precipitated material is arranged in a liquid crystalline micellar phase, consisting of small close-packed SDS micelles with peptide adsorbed at the interface. We were able to conclude that lanreotide does not form mixed micelles with SDS, indicating that it lacks the amphiphilic properties required to integrate fully with SDS behaving as a cosurfactant. In contrast, lanreotide attaches to the interface of SDS micelles, resembling the interactions of polymers, proteins, and nucleic acids with surfactants.

01 Feb 2026·JOURNAL OF NEUROENDOCRINOLOGY

Responses to medical treatment in patients with metastatic unresectable small intestinal neuroendocrine tumors – A single center study of 378 patients

Article

Author: Holmager, Pernille ; Andreassen, Mikkel ; Knigge, Ulrich ; Møller, Stine ; Slott, Cecilie ; Langer, Seppo W. ; Oturai, Peter ; Garbyal, Rajendra Singh ; Hansen, Carsten Palnæs ; Klose, Marianne ; Kjaer, Andreas

Abstract:

Small intestinal neuroendocrine tumors (siNET) are rare malignancies, often diagnosed at advanced stages with metastatic spread. While surgery is the only curative treatment, medical therapies, including somatostatin analogues (SSA), peptide receptor radionuclide therapy (PRRT), and other systemic treatments, are essential for disease stabilization. The aim was to assess median progression free survival (mPFS), and prognostic factors for the most frequently used medical treatment modalities in patients with unresectable disease. It was a retrospective single‐center cohort study, including 378 patients diagnosed with siNET between 2000 and 2020. The median overall survival (mOS) for the cohort was 97 (95% CI: 83–111) months. Median PFS for octreotide and lanreotide treatment/treated patients ( n = 255) was 30 (95% CI: 24–36) months and 5 years PFS was 32%, with no significant difference between the two agents. Risk factors for disease progression included age, Ki‐67 index, and gender (female as a protective factor). Median PFS for PRRT ( n = 140) was 31 (95% CI: 25–37) months. Thirty‐seven patients who had PFS > 18 months after the first 4 cycles received another 2 cycles of PRRT. Median PFS after the first 4 cycles was 37 (95% CI: 30–44) months versus 10 (95% CI: 6–14) months after the 2 additional PRRT cycles. Patients treated with everolimus had a median PFS of 5 (95% CI: 0.3–10) months, and chemotherapy with streptozocin and 5‐fluorouracil resulted in a median PFS of 8 (95% CI: 5–11) months. In conclusion, SSA remains the cornerstone of first‐line therapy for unresectable siNET, with PRRT offering a valuable alternative for patients with progression on SSA. Re‐introduction of PRRT with 2 additional cycles had reduced efficacy compared with the initial treatment. PFS was short in non‐somatostatin receptor‐based therapies like everolimus and chemotherapy.

News (Medical) associated with Lanreotide Acetate

12 Feb 2026

·www.biospace.com

Ipsen delivers strong results in 2025, driven by solid execution across all therapeutic areas, and provides 2026 guidance

FY 2025 sales growth of 10.9% at CER 1 , or 8.1% as reported, driven by growth of the three therapeutic areas of Oncology (4.1% 1 ), Rare Disease (102.5% 1 ) and Neuroscience (9.7% 1 ); Somatuline® sales growth of 4.3% 1 , with all other products, excluding Somatuline, achieving double-digit sales growth of 14.2% 1 FY 2025 core operating income of €1,294m, growing by 16.7% as reported, with a core operating margin of 35.2% of total sales, increasing by 2.6 points 2025 continued pipeline expansion, driven by significant regulatory and clinical milestones, integration of multiple preclinical assets with global rights and innovative approaches, and a mid-stage candidate from the acquisition of ImCheck Therapeutics Five major regulatory and clinical milestones expected in 2026, in addition to the full data readout for IPN10200 in an aesthetics indication Financial guidance 2 for 2026 including total sales growth greater than 13.0% 3 at CER, assuming an acceleration of our portfolio excluding Somatuline as well as the growth of Somatuline due to generic lanreotide production challenges, and core operating margin greater than 35.0% of total sales PARIS, FRANCE, 12 February 2026 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the full year (FY) 2025 and for the fourth quarter of 2025. Extract of consolidated results 4 for FY25 and FY24 FY 2025 FY 2024 % change €m €m Actual CER Total Sales 3,675.9 3,400.6 8.1 % 10.9 % Core Operating Income 1,294.1 1,109.4 16.7 % Core operating margin 35.2 % 32.6 % +2.6pts Core Consolidated Net Profit 1,009.1 857.8 17.6 % Core earnings per share (fully diluted) €12.09 €10.27 17.8 % IFRS Operating Income 625.9 496.7 26.0 % IFRS operating margin 17.0 % 14.6 % +2.4pts IFRS Consolidated Net Profit 444.5 347.3 28.0 % IFRS earnings per share (fully diluted) €5.32 €4.15 28.3 % Free Cash Flow 1,000.6 774.4 29.2 % Closing net cash/(debt) 559.9 160.3 n/a “In 2025, Ipsen delivered strong sales and profit growth,” said David Loew, Chief Executive Officer, Ipsen. “We continued to execute across all three therapeutic areas, with a notable performance from Iqirvo. We have advanced multiple pipeline programs and further strengthened our innovation engine through targeted business development, including the acquisition of Imcheck Therapeutics. We also achieved promising proof-of-concept for IPN10200, our first-in-class differentiated long-acting recombinant molecule. We are expecting another year of double-digit sales growth for 2026, supported by accelerated performance across the entire portfolio and a better outlook for Somatuline given the production challenges faced by generic competition. We anticipate five regulatory and clinical milestones this year and to further deliver on our external innovation strategy.” Full-year 2026 guidance and mid-term outlook Ipsen has set for FY 2026 the following financial guidance: Total sales growth greater than 13.0%, at constant currency. Based on the average level of exchange rates in January 2026, an adverse effect on total sales of around 2% of currencies is expected Core operating margin greater than 35.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities Guidance on total sales and core operating margin is assuming accelerated sales growth of the portfolio excluding Somatuline and the growth of Somatuline sales due to generic lanreotide challenges. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions. As part of its ongoing review of long-term assumptions including competitive intensity and product lifecycle considerations, Ipsen no longer expects to achieve the €500m peak sales for Onivyde and Tazverik. Based on higher expected Somatuline sales due to continued generic lanreotide production challenges and the performance of the broader portfolio, Ipsen is highly confident on its 2027 mid-term outlook to exceed the total-sales average growth 5 of at least 7% per year for the period 2023-27 and core operating margin in 2027 of at least 32% 6 of total sales. Pipeline progress During 2025, Ipsen achieved a number of important regulatory and clinical milestones across its portfolio, reflecting continued advancement of its pipeline across the three therapeutic areas. In the first quarter of 2025, the regulatory filing for tovorafenib, an oral, type II RAF-kinase inhibitor for pediatric low-grade glioma, was accepted for review by the European Medicines Agency (EMA). In May 2025, Ipsen presented Phase II data from the ELMWOOD study of Iqirvo® (elafibranor) at the European Association for the Study of the Liver (EASL) Congress, demonstrating a favorable safety pro dose-dependent efficacy over 12 weeks in people living with primary sclerosing cholangitis, a condition with high unmet medical need. In July 2025, the European Commission approved Cabometyx® (cabozantinib) for the treatment of previously treated advanced neuroendocrine tumors (NETs), based on positive results from the Phase III CABINET trial. In September 2025, positive Phase II data from the LANTIC trial in aesthetics were reported, demonstrating a differentiated, long-acting clinical pro IPN10200. During the year, Ipsen also initiated a Phase II study of IPN10200 in cervical dystonia, representing the fourth clinical study in the development plan of the global long-acting recombinant molecule across therapeutic and aesthetic indications. In December 2025, Ipsen announced that the pivotal Phase II FALKON trial of fidrisertib in fibrodysplasia ossificans progressiva (FOP) did not meet its primary endpoint and that the study was subsequently closed; fidrisertib was generally well-tolerated, with no safety concerns identified. In addition, Ipsen initiated multiple Phase I oncology studies across IPN01195, a RAF inhibitor, the antibody-drug conjugate IPN60300 and the T-cell activator IPN01203, further strengthening its targeted oncology pipeline. External innovation In December 2025, Ipsen expanded its immuno-oncology portfolio with the acquisition of ImCheck Therapeutics, a biotechnology company developing next-generation immuno-oncology therapies including IPN60340 (ICT01), a first-in-class monoclonal antibody targeting BTN3A, currently in Phase I/II development, with a Phase IIb/III study planned to start in 2026. IPN60340 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. Interim data orally presented at the annual American Society of Clinical Oncology 2025 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard-of-care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard-of-care (Ven-Aza). In January 2026, Ipsen also announced that IPN60340 received U.S. FDA Breakthrough Therapy Designation in first-line unfit acute myeloid leukemia. In December 2025, Ipsen further strengthened its oncology and early-stage pipeline through two additional targeted business development and research collaborations. Ipsen entered into an exclusive licensing agreement with Simcere Zaiming for rights outside Greater China to SIM0613, an antibody–drug conjugate (ADC) targeting LRRC15. Ipsen also announced a new research collaboration and option agreement with the Université de Montréal and IRICoR, encompassing two discovery-stage programs focused on novel inhibition of pathways complementary to the MAP kinase pathway. 2026 Upcoming Milestones Ipsen anticipates several key milestones across its portfolio in 2026, including: Tovorafenib (FIREFLY-1) - European regulatory decision for pediatric low-grade glioma Bylvay (BOLD) - Readout of pivotal Phase III in biliary atresia Iqirvo (ELSPIRE) - Readout of pivotal Phase III in primary biliary cholangitis Dysport (BEOND) - Readout of pivotal Phase III trials in chronic and episodic migraine IPN10200 (LANTIC) - Readout of Phase II in lateral canthal lines and forehead lines These milestones reinforce Ipsen’s commitment to advancing innovative therapies and expanding treatment options for patients worldwide. Full data from the Phase II LANTIC study of IPN10200, which demonstrated a positive first-in-class, differentiated long-acting clinical pro the initiation of Phase III, are expected to be presented in the first half of 2026 at an upcoming congress. Galderma arbitration In January 2026, the Arbitral Tribunal of the International Chamber of Commerce (ICC) issued a final decision in favor of Ipsen, dismissing the claim brought by Galderma in connection with Ipsen’s termination of the R&D agreement. The Tribunal confirmed Ipsen’s full rights to its clinical-stage toxin programs in the aesthetics field, including IPN10200. Ipsen continues to assess all options to maximize the value of its long-acting program. Environmental, Social and Governance Ipsen took important steps in 2025 to deliver its ambitious sustainability strategy, continuing to embed sustainability across its operations and decision-making. From reducing its environmental footprint to advancing patient access and strengthening its workplace culture, Ipsen reinforced its commitment to delivering progress for patients, employees, communities, and the planet. Ipsen made good progress across multiple environmental targets, including: 54% reduction in Scopes 1 & 2 greenhouse gas emissions (vs. a 2019 baseline) 16% reduction in Scope 3, fully in line with our 2030 targets (vs. a 2019 baseline) 100% of Ipsen’s global electricity now comes from renewable sources 55% of the company fleet now comprised of electric vehicles as of 2025 through the Fleet for Future Project Ipsen received an A rating from CDP for our best-practice environmental actions and transparency, and for demonstrating our comprehensive understanding of environmental dependencies, risks, and opportunities. Ipsen is proud to be one of the first biopharmaceutical companies to achieve full gender parity within the Executive Leadership Team, and with women now representing 53% of the Global Leadership Team. Consolidated financial statements The Board of Directors approved the consolidated financial statements on 11 February 2026. The consolidated financial statements have been audited, and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section. Conference call A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the webcast here . Analysts can join the call and ask questions by registering here . Calendar Ipsen intends to publish its Q1 2026 sales on April 23rd, 2026. Notes All financial figures are in € millions (€m), unless otherwise noted. The performance shown in this announcement covers the twelve-month period to 31 December 2025 (FY 2025) and the three-month period to 31 December 2025 (Q4 2025), compared to the twelve-month period to 31 December 2024 (FY 2024) and the three-month period to 31 December 2024 (Q4 2024), respectively, unless stated otherwise. The commentary is based on the performance in FY 2025, unless stated otherwise. 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 . Ipsen Contacts Investors Henry Wheeler henry.wheeler@ipsen.com +33 7 66 47 11 49 Khalid Deojee khalid.deojee@ipsen.com +33 6 66 01 95 26 Media Sally Bain sally.bain@ipsen.com +1 857 320 0517 Anne Liontas anne.liontas.ext@ipsen.com +33 7 67 34 72 96 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 . 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period. 2 Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions. 3 Based on the average level of exchange rates in January 2026, an adverse impact on total sales of around 2% from currencies is expected. 4 Extract of consolidated results. The Company’s auditors performed an audit of the consolidated financial statements. 5 CAGR 2023-2027 at constant exchange rates. 6 Excluding any impact from potential late-stage (Phase III clinical development or later) external-innovation transactions. Attachment Ipsen PR_FY 2025 Results Announcement_12022026

Breakthrough TherapyClinical ResultPhase 2Phase 3

04 Dec 2025

·www.debiopharm.com

Redefining Acromegaly Care: First Patient Randomized in Debiopharm’s Phase III OXTEND-03™ Trial of 3-Month Debio 4126 Treatment

OXTEND-03™ (NCT06930625) is a Phase III, multi-center, randomized trial assessing the efficacy and safety of Debio 4126, the first and only octreotide formulation designed for quarterly (3-month) dosing Lausanne, Switzerland – December 4th, 2025 – Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company committed to establishing tomorrow’s standards of care in oncology and rare diseases, today announced that the first patient has been randomized in the OXTEND-03™ clinical trial. This pivotal Phase III trial is designed to evaluate the efficacy and safety of Debio 4126, a novel long-acting octreotide formulation and the first potential 3-month somatostatin analogue (SSA), in adults with acromegaly who are currently maintained on somatostatin analogs. OXTEND-03™ is a global trial spanning approximately 75 sites across 21 countries, aiming to enroll around 120 patients. The primary goal of the trial is to confirm Debio 4126’s ability to maintain biochemical control of the disease while significantly reducing the patient’s annual treatment burden from 12 injections to just 4. This shift is expected to enhance patient convenience, improve long-term adherence, and potentially decrease healthcare resource utilization. “The dosing of the first patient in OXTEND-03™ is a monumental achievement for our team and confirms our commitment to addressing high unmet needs in rare diseases,” said Yanina Negievich, Medical Director for the Debio 4126 Program at Debiopharm. “Our goal with Debio 4126 is to empower patients by reducing the complexity of their treatment. Moving from monthly to quarterly injections could make a real difference, helping patients focus on living rather than managing their condition.” “Acromegaly management can be highly demanding due to the required monthly injections in many patients, which impose a significant physical and emotional burden. A quarterly treatment regimen could be a game-changer for both patients and healthcare professionals. The OXTEND-03™ trial is essential for validating Debio 4126 as a new, less burdensome option that maintains control, potentially leading to better patient adherence and overall well-being.” said Maria Fleseriu, MD, FACE, professor and director of pituitary center, global principal investigator Acromegaly is a rare, chronic endocrine disorder characterized by the pituitary gland’s excessive production of growth hormone. The estimated prevalence is between 28 and 137 cases per million people [1]. While current medical treatment typically involves Somatostatin Analogues (SSAs) delivered via lifelong, monthly deep subcutaneous or intramuscular injections, this regimen imposes a severe burden on patients. Data shows that up to 77% of patients experience treatment-related injection site reactions (ISRs), such as pain, swelling, and bruising [2]. Furthermore, many patients continue to struggle with persistent symptoms and impaired Quality of Life (QoL) despite achieving biochemical control [3, 4]. This demanding and frequent injection schedule, coupled with these persistent issues, is a major source of patient suffering and anxiety. Debio 4126, with its quarterly dosing interval, directly addresses this critical unmet need by offering the prospect of maintained biochemical control with significantly reduced injection frequency. Debio 4126 is an innovative, long-acting octreotide formulation designed for intramuscular administration every three months. Early clinical data and robust pharmacokinetic modeling have demonstrated sustained octreotide release, consistent inhibition of Insulin-like Growth Factor 1 (IGF-1), and a safety profile comparable to marketed SSAs, providing strong support for the initiation of this Phase III trial. The OXTEND-03™ trial is a Phase III, multi-center, randomized, 3-arm trial (double-blind Debio 4126, placebo control, and open-label Debio 4126 extension). It will enroll approximately 120 adult patients with acromegaly who have been previously treated with octreotide or lanreotide and have IGF-1 levels within the normal range. The trial has an expected duration of up to 2 years of treatment. Debiopharm aims to develop innovative therapies that target unmet needs in oncology and bacterial infections. To bridge the gap between breakthrough discoveries and patient access, Debiopharm identifies high-potential compounds, undertakes clinical development, and then partners with major pharmaceutical companies to bring medicines to the market and make them accessible to as many patients as possible throughout the world. Visit us at www.debiopharm.com Follow us on LinkedIn: https://www.linkedin.com/company/debiopharminternational/ References [1] Kyriakakis, N., et al. “Quality of life in patients with acromegaly: a scoping review.” Frontiers in Endocrinology. (2024). [2] Gadelha, M. R., et al. “Disease and Treatment-Related Burden in Patients With Acromegaly Who Are Biochemically Controlled on Injectable Somatostatin Receptor Ligands.” The Journal of Clinical Endocrinology & Metabolism. (2021). [3] Shevchenko, Y., et al. “The socioeconomic burden of acromegaly.” European Journal of Endocrinology. (2023). [4] Tritos, N. A., et al. “Patient-centered assessment on disease burden, quality of life, and treatment satisfaction associated with acromegaly.” Pituitary. (2017)

Phase 3Oligonucleotide

22 Oct 2025

·www.globenewswire.com

Ipsen delivers strong sales in the first nine months of 2025 and further upgrades its full-year guidance

Year-to-date total sales growth of 12.1% at CER1, or 9.6% as reported, driven by all three therapeutic areas and including strong performance from Iqirvo®, Bylvay® and Somatuline® Further upgrade of full-year 2025 financial guidance based on slower than anticipated erosion of Somatuline® and accelerated sales growth of the rest of the portfolio: total sales growth of around 10.0%2 at CER (prior guidance greater than 7.0%); core operating margin of around 35.0% of total sales (prior guidance greater than 32.0%)Announcement today of the proposed acquisition of ImCheck Therapeutics bringing a first-in-class Phase II asset, expanding pipeline in oncology PARIS, FRANCE, 22 October 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its sales for the year to date and the third quarter of 2025. YTD 2025 YTD 2024 % change Q3 2025 Q3 2024 % change €m €m Actual CER €m €m Actual CER Oncology 1,912.0 1,829.8 4.5 % 6.6 % 624.0 604.0 3.3 % 7.0 % Rare Disease 255.4 129.7 97.0 % 101.0 % 102.0 50.8 100.8 % 109.1 % Neuroscience 567.3 536.4 5.8 % 9.5 % 188.9 181.9 3.9 % 9.1 % Total Sales 2,734.8 2,495.9 9.6 % 12.1 % 915.0 836.6 9.4 % 13.7 % “We have demonstrated strong momentum through the first nine months of 2025, with solid growth across all three therapeutic areas and increasing contributions from our rare liver disease franchise. As a result, we are further upgrading our full-year guidance to reflect this performance." said David Loew, Chief Executive Officer, Ipsen."This quarter, we were also pleased with the data from the Phase II LANTIC trial in aesthetics, with a differentiated first-in-class long-acting molecule, IPN10200. With the proposed acquisition of ImCheck Therapeutics announced this morning, we are adding a first-in-class asset to expand our oncology pipeline. Our efforts remain focused on advancing science with purpose to bring the benefits patients are looking for, as we believe everyone deserves a life fully lived.” Full-year 2025 guidanceBased on the strong performance in the third quarter, Ipsen further upgrades its financial guidance for 2025: Total sales growth of around 10.0%, at CER (prior guidance greater than 7.0%). Based on the average level of exchange rates in September 2025, an adverse impact on total sales of around 3% from currencies is expectedCore operating margin of around 35.0% of total sales (prior guidance greater than 32.0%) This guidance assumes a limited impact from lanreotide generic on Somatuline® sales and an accelerated sales growth from the rest of the portfolio. Pipeline update for Q3 2025On 22 September 2025 Ipsen announced that the LANTIC Phase II trial in aesthetics delivered a first-in-class, differentiated long-acting clinical profile for IPN10200, a recombinant, first-in-class molecule uniquely engineered to generate increased receptor affinity and internalization that produces a longer duration of action. Data showed a rapid onset of action, peak effect superior to placebo and a substantial majority of patients experiencing clinically significant longer duration of effect vs placebo and vs Dysport®, defined as a score of “none” or “mild” of line severity at Week 24. The data will be presented at an upcoming scientific conference in H1 2026, and Phase III start-up activities have been initiated. On 19 September 2025 Ipsen announced regulatory approval for Bylvay® (odevixibat) for the treatment of pruritus associated with progressive familial intrahepatic cholestasis (PFIC) in Japan, offering a non-surgical treatment option for infants, young children and adults. On 23 July 2025, Ipsen received European Commission approval for Cabometyx® (cabozantinib) in previously treated advanced neuroendocrine tumors (NETs), based on positive outcomes from the Phase III CABINET trial. Business developmentOn 22 October 2025 Ipsen announced a definitive share purchase agreement to acquire ImCheck Therapeutics, a private French biotechnology company pioneering next-generation immuno-oncology therapies. The acquisition is focused on the lead Phase I/II program ICT01 in first line unfit acute myeloid leukemia (AML) with a Phase IIb/III to start in 2026. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer, and which has received Orphan Drug Designation from the U.S. Food and Drug Administration and Orphan designation from the European Medicines Agency in July 2025. Under the terms of the agreement, shareholders of ImCheck Therapeutics will receive a €350m cash payment at closing of the transaction, and deferred payments contingent upon the achievement of specified regulatory approvals and sales-based milestones. The transaction is expected to close by the end of Q1 2026, subject to fulfilment of customary closing conditions. Conference callA conference call and webcast for investors and analysts will begin today at 1pm CET. Participants can access the call and its details by registering here; webcast details can be found here. CalendarIpsen intends to publish its full-year and fourth-quarter results on 12 February 2026. NotesAll financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2025 (YTD 2025) and the three-month period to 30 September 2025 (Q3 2025), compared to the nine-month period to 30 September 2024 (YTD 2024) and the three-month period to 30 September 2024 (Q3 2024), respectively, unless stated otherwise. Commentary is based on the performance YTD 2025, unless stated otherwise. 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. Ipsen Contacts Investors Henry Wheeler henry.wheeler@ipsen.com - +33 7 64 47 11 49 Khalid Deojee khalid.deojee@ipsen.com - +33 6 66 01 95 26 Media Sally Bain sally.bain@ipsen.com - +1 857 320 0517 Anne Liontas anne.liontas.ext@ipsen.com - +33 7 67 34 72 96 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. 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period. 2 Based on the average level of exchange rates in September 2025, an adverse impact on total sales of around 3% from currencies is expected. Attachment Ipsen PR_YTD 2025 Results Announcement_22102025

Phase 2Clinical ResultAcquisitionDrug ApprovalOrphan Drug

100 Deals associated with Lanreotide Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D04666	Lanreotide Acetate	H01CB03	DB06791

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pituitary Neoplasms	Japan	Teijin Ltd.	15 Jan 2021
Gigantism	Japan	Teijin Ltd.	08 Jan 2013
Gastro-Enteropancreatic Neuroendocrine Tumor	Australia	Ipsen Pty Ltd.	11 Sep 2003
Carcinoid Tumor	South Korea	Ipsen Ltd.	08 Aug 2002
Neuroendocrine Tumors	South Korea	Ipsen Ltd.	08 Aug 2002
Acromegaly	China	Ipsen Pharma Biotech SAS	14 Mar 2002
Malignant Carcinoid Syndrome	China	Ipsen Pharma Biotech SAS	14 Mar 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neuroendocrine neoplasm of lung	Phase 3	United States	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Austria	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Canada	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Denmark	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	France	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Germany	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Italy	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Netherlands	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Poland	Ipsen SA	06 Mar 2017
Neuroendocrine neoplasm of lung	Phase 3	Spain	Ipsen SA	06 Mar 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GI2026	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor	53	Lanreotide	ecpntfieqj(htdaavjlzs) = byufmavyjm felvrxedrp (uttswepcxx ) View more	Positive	08 Jan 2026
KINETICS (ESMO2025)	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor First line	310	Lanreotide autogel (Ki67 <10%)	ysizthfzyt(iirqkukdch) = fdujxuexes snzgotprhs (dyxnfrmbih ) View more	Positive	17 Oct 2025
				Lanreotide autogel (Ki67 ≥10%)	ysizthfzyt(iirqkukdch) = woqpwhijon snzgotprhs (dyxnfrmbih ) View more
JPRN-jRCT1031200023 (JCOG1901, ESMO2025)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor First line	178	Everolimus + Lanreotide	tbmlbtixxb(ptwafnczyl) = scshmgeufw azyzqdhgsc (vhdlrnnwql ) View more	Positive	17 Oct 2025
				Everolimus	tbmlbtixxb(ptwafnczyl) = spkbzryyfa azyzqdhgsc (vhdlrnnwql ) View more
NCT05048901 (TCOG 2221, ESMO2025)	Phase 1/2	Gastro-Enteropancreatic Neuroendocrine Tumor	42	Cabozantinib 60 mg dailyLanreotide 120 mgg daily + Cabozantinib 60 mg dailyLanreotide 120 mg	zkykyyskpd(iqopqisemb) = nkqcooivqc tkiikcezwq (kvregxlqdd, 11.0 - 18.3) View more	Positive	17 Oct 2025
				Lanreotide 120 mg (pancreatic NET (panNET))	zkykyyskpd(iqopqisemb) = zyspcapqlk tkiikcezwq (kvregxlqdd )
KINETICS (ESMO_GI2025)	Not Applicable	First line Ki67 proliferation index	314	LAN (Somatuline Autogel)	uablnszjze(vcxruycgnp) = qdchzlprgf jkihgrfaya (woswgamkas )	-	03 Jul 2025
NCT03946527 (phase 2 study of lanreotide, ASCO2025)	Phase 2	Paraganglioma \| Pheochromocytoma SDHx mutation	18	Somatuline Depot / Lanreotide Autogel	spctjolrsv(lrhznbosgj) = rumgcaeyur kfxjqwlixu (oqwjtprdhs ) View more	Positive	30 May 2025
NCT03289741 (CTgov)	Phase 4	Neuroendocrine Tumors	51	Octreotide+LAR Lanreotide (Octreotide Then Lanreotide)	csnwzvjmlf(lvsoaykitn) = zskhyfgvpi ciowlhpsnv (ogjtnfcuir, efqqhzfgqz - qrlhhcipqe) View more	-	09 May 2025
				Octreotide+LAR Lanreotide (Lanreotide Then Octreotide)	zobgnjnsuu(decxlqejci) = xwzflqrtsa rreitlpizm (ttfvqdfdmm, wlbrhzpwnn - qqmnkwcswy) View more
JPRN-jRCT1031200023 (JCOG1901, STARTER-NET, ASCO_GI2025)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor First line diffuse liver metastases	178	Everolimus	gjtdxmlrtq(dqbhaybviy) = oyhqbjsnhb uemnltbgkn (uppyaazyzz ) View more	Positive	23 Jan 2025
				Everolimus + Lanreotide	gjtdxmlrtq(dqbhaybviy) = nnxvnkcbvp uemnltbgkn (uppyaazyzz ) View more
ASCO_GI2025	Not Applicable	Gastric Neuroendocrine Tumor Adjuvant ki67	35	Somatostatin analogs (long-acting releasing octreotide 30 mg)	iqcuceghkm(fyfepfhcqn) = olodvzwoza zecqhcowpp (xdqadupwqh, 67 - NR)	Positive	23 Jan 2025
				Lanreotide 120 mg	iqcuceghkm(fyfepfhcqn) = rrfztworvz zecqhcowpp (xdqadupwqh, 67 - NR)
NCT04852679 (PALACE, CTgov)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	43	Lanreotide autogel	adexfrxqew = yjpwilkzcd lmtttfwugr (vqipwiczwg, fyhfctkmjr - jtevpmsbdt) View more	-	01 Oct 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis