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Ipsen is a French biopharmaceutical company headquartered in Paris, France, with a focus on drug development and commercialization in three therapeutic areas: oncology, rare diseases and neuroscience. Ipsen is one of the world's top 15 biopharmaceutical companies in terms of oncology sales.[2][3]

Key Information

Ipsen, founded by Henri Beaufour in 1929, has approximately 5000 employees worldwide. Ipsen's medicines are registered in 88 countries with direct commercial presence in over 30 countries. Ipsen has 4 global R&D hubs and 3 pharmaceutical development centers around the world. Ipsen has been a family-owned business for the past 90 years and is publicly traded on the Euronext Paris as part of the SBF 120 index (2005).[4][5] The Beaufour family owns 57% of its shares and 73% of its voting rights, and two of its members, Anne Beaufour and Henri Beaufour, sit on its board of directors.[6]

History

[edit]

In 1929, Dr. Henri Beaufour founded the Beaufour Laboratories in Dreux. The first product marketed was Romarene, a rosemary-based medicine intended for the treatment of digestive disorders, discontinued from the market in 2011.

In the 1950s and 1960s, Laboratoires Beaufour underwent a phase of expansion. In 1954, the group launched betaine citrate, used in the symptomatic treatment of dyspepsia. Henri Beaufour's two sons, Albert and Gérard Beaufour, joined the company.[6] The group opened a factory in Dreux in 1961,[7] and another in L'Isle- sur-la-Sorgue in 1965. A research center opened in Plessis-Robinson the same year.

In the 1970s and 1980s, Laboratoires Beaufour created a subsidiary, Ipsen (1975), and began to internationalize its activities. In 1976, the company opened a research center in Milford (Massachusetts) in the U.S. In 1977, the group launched Smecta (diosmectite clay, a gastrointestinal bandage and anti-diarrhoeal agent).[7]

In 1983, the group created the Fondation Ipsen under the aegis of the Fondation de France, to encourage exchanges between scientists in the field of life sciences.[8]

In 1986, the group launched Decapeptyl,[7] used to treat certain pathologies influenced by sex hormones, such as prostate cancer, endometriosis, uterine fibroids and early puberty.

In the 1990s, the group diversified its activity and continued its international expansion. In 1990, an industrial center was created in Signes, in the Var department. In 1992, the group opened a subsidiary in China. In 1994, the group launched Dysport (type A botulinum toxin for the treatment of muscle spasms) after acquiring the British company Speywood (then called Porton International).[9] The same year, the group opened a subsidiary in Russia.

In 1995, the group launched Somatuline,[7] used to treat hypersecretion of growth hormones (acromegaly) and in neuro-endocrine tumors, and in 1996, Forlax[7] was launched.

In 2000, after the death of Albert Beaufour, the company was taken over by his children, Anne Beaufour and Henri Beaufour.

In 2003, the company changed its name to Ipsen[10] and in 2005, it was listed on the Paris Stock Exchange[11] on Euronext. In 2004, the company inaugurated a new botulinum toxin production unit in Wrexham (UK). In 2007, the company established a partnership with Galderma for botulinum toxin type A products in aesthetic medicine. In addition, somatuline was granted marketing authorization in the United States for the treatment of acromegaly.

In 2007, Ipsen shares were included in the SBF 120 stock market index.

In 2007, Dysport was granted marketing authorization in the United States for certain indications in therapeutic and aesthetic medicine. Decapeptyl 6-month formulation receives marketing authorization in 9 European countries from the European Medicines Agency.

In 2011, Ipsen announced a new strategy focusing on several areas, including a refocus on specialty medicine, research and development and international development.[4] In 2013, Ipsen acquired the British company Syntaxin, a leader in the engineering of recombinant botulinum toxin11. In 2014, the company participated in the creation of a joint laboratory with the CNRS – Archi-Pex -, the Commissariat à l'énergie atomique et aux énergies alternatives and the University of Rennes1, with the aim of designing and developing hormone peptides.

In 2015, Ipsen inaugurated a research and development center in Cambridge, Massachusetts.[12]

In 2016, Dysport Injection was approved in the United States for the treatment of lower limb spasticity in children aged two years and older.[13]

In 2016, Ipsen licensed cabozantinib from Exelixis, which received marketing authorization the same year for the second-line treatment of advanced renal cell carcinoma. In January 2017, Ipsen announced the acquisition of certain assets of Merrimack Pharmaceuticals, including Onivyde, for the treatment of pancreatic and ovarian cancer.[14]

In 2019, Ipsen acquired Montreal-based Clementia Pharmaceuticals, specializing in rare bone diseases,[15],[16],.[17] Clementia brought a drug candidate, palovarotene, to Ipsen for a rare genetic disease, fibrodysplasia ossificans progressiva (FOP).

In February 2022, Ipsen announced the proposed sale of the Consumer HealthCare (CHC) division after entering into exclusive negotiations with the French laboratory Mayoly Spindler.[18]  In July 2022, Ipsen completed the divestment of the CHC business to Mayoly Spindler.

In August 2022, Ipsen successfully completed the acquisition of Epizyme and its lead medicine, Tazverik® (tazemetostat), a first-in-class, chemotherapy-free EZH2a inhibitor for adults with relapsed or refractory follicular lymphoma (FL), which was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) in 2020. As part of the transaction, Ipsen also acquired Epizyme's first-in-class, oral SETD2 inhibitor development candidate.

In January 2023, Ipsen announced it would acquire rare disease specialist Albireo for $952m, bringing into its portfolio Bylvay (odevixibat), a non-systemic ileal bile acid transport inhibitor for the treatment of paediatric patients with pruritus in progressive familial intrahepatic cholestasis (PFIC).[19][20]

In August 2023, The U.S. Food and Drug Administration (FDA) approved Sohonos for the treatment of fibrodysplasia ossificans progressiva (FOP), a rare genetic connective tissue disease that causes progressive loss of mobility and shortened life expectancy, in adults and children. It can be used for girls aged 8 years and older and boys aged 10 years and older. The estimated annual cost of the drug is from $624,000. The disease occurs in 1 in 1,600,000 newborns, with about 800 people now known to have the disease.[21]

In February 2024, Ipsen received FDA approval for Onivyde (irinotecan liposome injection), which is used in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (mPDAC). Pancreatic cancer accounts for approximately 3% of all cancer diagnoses in the United States and approximately 7% of all cancer deaths. PDAC is the most common form of the disease, with more than 60,000 diagnoses in the United States each year and approximately 500,000 diagnoses worldwide.[22]

In June 2024, Ipsen received accelerated approval from the US FDA for Iqirvo elafibranor based on positive Phase III ELATIVE trial data. elafibranor is a treatment for 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.[23][24]

Controversies

[edit]

As of March 2022, Ipsen announced the suspension of certain promotional activities in Russia, including advertising and participation in non-scientific congresses. Additionally, the company decided not to initiate any new clinical trials in the country. Despite Russian invasion in Ukraine, Ipsen continues to serve patients in Russia, maintaining the availability of its existing medications.[25]

Financial Data

[edit]
Financial data in EUR millions
Year 2017 2018 2019 2020 2021 2022[26] 2023[27]
Total sales 1,908.7 2,224.8 2,576.2 2,591.6 2,643.3 3,025.0 3,127.5
Change vs prior year – at actual exchange rates 21.1% 16.6% 15,8% 3.5% 10.7% 14.4% 3.4%
Core operating margin 20.8% 29.7% 30,4% 32,0% 35.2% 36.9% 32.0%
Employees 5,400 5,700 5,800 5,700 5,700 5,700 5,700

Shareholding

[edit]

Ownership of Ipsen's share capital (% of total capital) as of 31 December 2022:[28]

Name % of total capital
Free float 40.86%
Beech Tree 26.03%
Highrock 26.03%
MR Schwabe 4.34%
Treasury shares 1.3%
Finvestan 0.22%
Other registered shareholders 0.79%
Employee 0.25%
Directors (others) 0.17%

Medicines

[edit]

In Oncology

[edit]

Cabometyx[29] (cabozantinib) is a tyrosine kinase inhibitor (TKI) used in the treatment of advanced kidney cancer (renal cell carcinoma), liver cancer (hepatocellular carcinoma) in adults previously treated with the medicine sorafenib, as well as in radioiodine-refractory differentiated thyroid cancer (RAI-R DTC) after prior systemic therapy

Decapeptyl[29] (triptorelin) is an analogue of the natural gonadotropin-releasing hormone (GnRH), approved for the treatment of locally advanced metastatic prostate cancer, central precocious puberty (CPP), endometriosis, uterine fibroma, and in-vitro fertilization, and used as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor for women at high-risk of breast cancer recurrence.

Somatuline[29] (lanreotide) is a synthetic version of the natural hormone somatostatin, which is found naturally in the human body. Used for the treatment of neuroendocrine tumors (NETs), carcinoid syndrome or acromegaly.

Onivyde[29] (irinotecan liposome injection) is prescribed in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Tazverik is an inhibitor of the enzyme EZH2 (enhancer of zeste homologue 2) used to treat follicular lymphoma, which is a cancer of the immune system, as well as epithelioid sarcoma which is a rare, slow-growing type of soft tissue cancer which often begin in the soft tissue under the skin of a finger, hand, forearm, lower leg or foot, and in the abdomen or pelvic area.

These indications are approved under FDA accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Rare Disease

[edit]

Increlex[29] (mecasermin) injection is a prescription medicine used to treat children who are very short for their age because their bodies do not make enough IGF-1. This condition is called primary IGF-1 deficiency.

Sohonos[30] (palovarotene) is an oral investigational, selective retinoic-acid receptor gamma (RARγ) agonist being developed as a potential treatment for people living with the debilitating ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP).

In Neuroscience

[edit]

Dysport[29] (Botulinum toxin) is a prescription medicine used for pathologies characterized by involuntary and uncomfortable muscle contractions (dystonias: blepharospasm, spasmodic torticollis, hemifacial spasm; spasticity: spasticity of the upper or lower limb, dynamic deformation of the equine foot). This drug is also used in aesthetic medicine to temporarily reduce certain wrinkles.

Fondation Ipsen

[edit]

The Fondation Ipsen pour la recherche thérapeutique, created in 1983 under the aegis of the Fondation de France, supports work in the field of therapeutic research. In particular is focused on helping improve the lives of patients with rare diseases.[8]

It has contributed to numerous major advances in biological and medical research, organized scientific conferences, and produced literature and content to help patients and the wider community understand rare diseases.

Since 2007, Fondation Ipsen has initiated several series of meetings in partnership with the Salk Institute, the Karolinska Institutet, the Massachusetts General Hospital, the DMMGF (Days of Molecular Medicine Global Foundation), as well as with the journals Nature, Cell and Science. The Fondation Ipsen has published more than 100 books and awarded more than 250 prizes and grants.

In 2021, Fondation Ipsen worked directly with 146 organizations to assess the needs of patients with rare diseases. Fondation Ipsen and Science Magazine organized 9 webinars with the world's leading specialists in rare diseases, as well as policymakers from all over the world.The webinars addressed a variety of essential topics for patients living with rare diseases and their families. The webinars received such a strong response that Science Magazine and the Fondation now co-publish an international magazine for the rare disease community: The Rare Disease Gazette.

References

[edit]
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Ipsen

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Ipsen S.A. is a French multinational biopharmaceutical company founded in 1929 as a family-owned enterprise initially known as Laboratoires Beaufour. Headquartered in Paris, the company specializes in the research, development, and commercialization of innovative therapies targeting oncology, rare diseases, and neuroscience, areas characterized by significant unmet patient needs. Key products include Somatuline® (lanreotide), a somatostatin analog for treating neuroendocrine tumors and acromegaly; Dysport® (abobotulinumtoxinA), used for neurological disorders such as cervical dystonia and spasticity; and Cabometyx® (cabozantinib), a tyrosine kinase inhibitor for renal cell carcinoma and hepatocellular carcinoma. Ipsen has grown through strategic acquisitions, such as Epizyme in 2022 for lymphoma treatments and Albireo in 2023 for pediatric rare liver diseases, alongside partnerships that bolster its pipeline of over 30 programs since 2020. While the company maintains a focus on transformative specialty medicines, it has faced regulatory disputes, including a 2024 court loss to the FDA classifying Somatuline Depot as a drug rather than a biologic, and isolated employee insider trading incidents unrelated to corporate policy.

Company Overview

Corporate Profile and Mission

Ipsen is a French biopharmaceutical company founded in 1929 as a and headquartered in . The firm operates as a global mid-sized player specializing in transformative medicines within three core therapeutic areas: , rare diseases, and . This focus positions Ipsen as a niche-oriented entity rather than a broad-spectrum pharmaceutical giant, emphasizing areas of high unmet medical need. As of late 2024, Ipsen employed 5,358 individuals worldwide, supporting its operations across multiple continents. In 2025, the company reported robust sales performance, with total sales for the first nine months growing approximately 9.6% at constant exchange rates compared to the prior year, prompting an upgraded full-year guidance of around 10% total sales growth. contributed significantly, accounting for a substantial portion of revenues, underscoring Ipsen's competitive standing in this domain. Ipsen's mission centers on prolonging and improving patients' lives through science-driven , with a commitment to positive societal impact via its ESG framework. The company's vision is to become a leading global mid-sized firm by delivering best- or first-in-class therapies in targeted, underserved therapeutic niches. This approach prioritizes empirical advancements in to address complex medical challenges.

Strategic Focus Areas

Ipsen prioritizes three core therapeutic areas—oncology, rare diseases, and neuroscience—where unmet medical needs are pronounced and the company holds specialized capabilities in delivering targeted interventions. This deliberate narrowing of scope, formalized in its 2020 group strategy, contrasts with diversified pharmaceutical models by emphasizing niche markets amenable to precision medicine and external innovation, while divesting from consumer healthcare to allocate resources efficiently. Central to this approach is a reliance on partnerships and acquisitions for expansion, with more than 30 programs integrated since 2020 across all development stages in these domains, reducing dependence on costly internal discovery. In , efforts target difficult-to-treat cancers through mechanisms like modulation; rare diseases address genetic and liver conditions with high unmet needs, such as ; and leverages applications for and . This external sourcing model fosters science-driven collaborations, prioritizing patient-centric outcomes over broad-spectrum pursuits. The rationale is underpinned by empirical market dynamics, including robust growth in rare diseases—evidenced by 101% year-to-date sales increase through September 2025—validating the focus on underserved segments where therapies can yield disproportionate impact relative to investment. benefits from established commercial traction, while pipeline advancements support sustained momentum, as seen in recent expansions and upgraded full-year guidance. Overall, this positions Ipsen to navigate competitive pressures by concentrating on areas of scientific feasibility and causal drivers of therapeutic success, such as precision targeting of disease pathways.

Global Presence and Operations

Ipsen operates with direct commercial presence in over 30 countries and registers its medicines in 88 countries, supported by approximately 5,000 employees worldwide. Its manufacturing infrastructure includes sites in , such as the biologics facility in , , and production capabilities in , alongside North American operations including a manufacturing site in . In the United States, a key market, Ipsen conducts activities through its subsidiary Ipsen Biopharmaceuticals, Inc., headquartered in , which oversees commercialization and related functions. The company's emphasizes efficiency in biologics and specialty pharmaceuticals, with facilities recognized for , such as Wrexham's adherence to high standards. Ipsen's distribution relies on partnerships to extend reach, exemplified by its exclusive licensing agreement with for commercializing (branded as Cabometyx) outside the and , enabling targeted asset deployment without full in-house infrastructure in every region. This model supports scalable operations amid global regulatory variances. Empirical performance underscores operational effectiveness: in the first nine months of 2025, total sales grew 12.1% at constant exchange rates, propelled by contributions from (6.6%), rare diseases (101.0%), and (9.5%), reflecting robust geographic and infrastructural alignment.

Historical Development

Founding and Early Expansion (1929–1960s)

Ipsen originated as Laboratoires Beaufour, founded in 1929 by Dr. Henri Beaufour in , , as a family-owned enterprise focused on developing pharmaceuticals from natural plant extracts to address unmet medical needs. The company's inaugural product, Romarene®, was a rosemary-derived remedy marketed for treating digestive disorders, reflecting an initial emphasis on botanical-based therapies for gastrointestinal and related conditions. This approach leveraged accessible natural resources, enabling small-scale production and distribution primarily within the during the . Amid the economic and wartime disruptions of the 1930s and 1940s, Laboratoires Beaufour sustained operations as a modest family business, prioritizing resilience through localized manufacturing and sales of extract-derived medicines. Post-World War II reconstruction facilitated initial expansion, with the firm capitalizing on France's recovering healthcare infrastructure to broaden its domestic footprint and refine production processes for plant-based pharmaceuticals. By the 1950s and early 1960s, the experienced a phase of organizational growth, transitioning from artisanal methods toward more structured pharmaceutical development while remaining rooted in natural sourcing. This period laid essential groundwork for future innovations, as the family enterprise adapted to emerging scientific advancements in extraction and , though it had not yet pivoted significantly to synthetic compounds.

International Growth and Diversification (1970s–1990s)

In the , Laboratoires Beaufour, the predecessor entity, created the Ipsen in 1975 to advance in synthetic peptides, enabling diversification beyond traditional extracts into innovative therapeutic compounds. This move coincided with initial efforts, including the establishment of a center in , in 1976, which supported early U.S. market penetration via technology transfer and clinical development rather than direct sales. Concurrently, a was opened in the that year, extending operations into key European markets and laying groundwork for amid evolving pharmaceutical standards in . The 1980s saw accelerated diversification through peptide-based innovations, exemplified by the 1986 launch of Decapeptyl (), a used in and as a precursor to applications for hormone-dependent cancers like prostate . This product stemmed from partnerships, such as with Debiopharm, leveraging Ipsen's expertise in to address unmet needs in hormone therapies, which drove revenue growth via expanded licensing agreements across . International presence strengthened with additional subsidiaries and R&D investments, capitalizing on post-1970s regulatory harmonization in the EEC that facilitated cross-border approvals and reduced barriers to peptide . During the 1990s, Ipsen pursued opportunistic acquisitions and market entries to scale globally, including the 1994 purchase of Speywood Laboratories in the UK, which added botulinum toxin expertise for neuroscience applications like Dysport for muscle spasticity. Subsidiaries were established in China in 1992 and Russia in 1994, marking entry into Asia and emerging markets to tap demand for endocrinology treatments amid economic liberalization. Further diversification included the 1995 introduction of Somatuline (lanreotide) for acromegaly and neuroendocrine tumors, reinforcing endocrinology and early oncology focus through somatostatin analog technology. These steps, supported by an industrial center in Signes, France, opened in 1990, enabled production scaling and positioned Ipsen to exploit peptide advancements in a consolidating industry landscape.

Therapeutic Specialization and Recent Milestones (2000s–2025)

In the , Ipsen refocused its efforts on specialty therapeutics in and , building on its expertise in peptide-based treatments such as somatostatin analogs like (Somatuline), which target gastroenteropancreatic neuroendocrine tumors and by inhibiting hormone secretion through binding. This pivot emphasized high-unmet-need areas over broader diversification, enabling resource allocation toward innovative modalities amid a competitive pharmaceutical landscape shifting toward biologics and targeted therapies. The 2010s saw Ipsen advance through strategic licensing agreements, including the 2016 European Commission approval of cabozantinib (Cabometyx) for advanced renal cell carcinoma following prior vascular endothelial growth factor inhibitor therapy, in partnership with Exelixis. Expansions followed, such as additional indications in hepatocellular carcinoma, reinforcing Ipsen's oncology footprint via external innovation rather than internal discovery alone. Into the 2020s, Ipsen sustained momentum with regulatory successes and portfolio enhancements from acquisitions and licenses, exemplified by the July 23, 2025, approval of Cabometyx for previously treated advanced neuroendocrine tumors (pancreatic and extrapancreatic), the first for this indication based on benefits from the CABINET phase III trial. This complemented external deals like the 2021 acquisition of Pharma, integrating odevixibat (Bylvay) for rare in conditions such as and progressive familial intrahepatic cholestasis, which drove rare diseases sales growth of 74.6% in Q1 2025 through expanded access and volume uptake. Overall, these factors contributed to year-to-date sales through September 2025 rising 12.1% at constant exchange rates, reflecting empirical demand in niche indications over generalized market expansion.

Research, Development, and Innovation

R&D Strategy and Pipeline

Ipsen's R&D strategy adopts a hybrid approach that integrates internal discovery with a strong reliance on external to construct a high-value targeting , rare diseases, and . This model prioritizes first- and best-in-class therapies, drawing on global scientific hubs and selective external sourcing to address unmet needs while optimizing in an industry characterized by high failure rates exceeding 90% in early clinical phases. Since 2020, the company has added more than 30 programs to its pipeline across development stages, with external innovation fueling the majority to expedite progress and diversify risk exposure. Emphasis is placed on late-stage assets to reduce attrition vulnerabilities, complemented by internal investments in precision medicine modalities, such as biomarker-driven targeted therapies in solid tumors and hematologic malignancies. This pipeline expansion aligns with a focus on causal mechanisms in , aiming to improve outcomes over broad-spectrum alternatives. R&D expenditures totaled €365 million in the first half of 2025, equating to 20.1% of sales and reflecting a 12.8% year-over-year increase driven by commitments to advancement, including early initiatives. This disciplined spending supported a 21.9% growth in core operating income to €656 million, achieving a 36.0% margin amid 11.4% sales expansion at constant exchange rates, underscoring the strategy's efficiency in translating innovation into financial resilience without proportional cost escalation.

Key Partnerships, Acquisitions, and External Collaborations

Ipsen has strategically engaged in partnerships and acquisitions to access external and accelerate development in , rare diseases, and , thereby mitigating the high costs of independent trials estimated at over $1 billion per asset. In 2016, Ipsen entered an exclusive licensing agreement with for (branded as Cabometyx), securing commercialization and development rights outside the and , which has supported expanded indications including advanced and neuroendocrine tumors. This collaboration was further amended in July to advance Cabometyx in advanced neuroendocrine tumors following positive Phase III CABINET trial data. In , Ipsen acquired Syntaxin, a UK-based specialist in recombinant engineering, in July 2013 for an upfront payment of £50 million plus milestone-based payments potentially reaching €158 million ($206 million). The deal enhanced Ipsen's capabilities in toxin-based therapies for , integrating Syntaxin's proprietary platforms with Ipsen's existing research. Recent expansions in rare diseases include the March 2023 acquisition of Albireo Pharma for $952 million, adding Bylvay (odevixibat) for progressive familial intrahepatic cholestasis and other pediatric cholestatic liver diseases to Ipsen's portfolio. In oncology, Ipsen completed the $247 million acquisition of Epizyme in June 2022, incorporating Tazverik (tazemetostat) for relapsed or refractory follicular lymphoma and epithelioid sarcoma. Licensing agreements have further diversified assets, such as the April 2024 global deal with Sutro Biopharma for STRO-003, an antibody-drug conjugate targeting B7-H4 for solid tumors, and the July 2024 ex-U.S. license with Day One Biopharmaceuticals for tovorafenib in pediatric low-grade glioma. In August 2022, Ipsen partnered with Marengo Therapeutics to co-develop two precision immuno-oncology candidates from the STAR platform. As of October 2025, Ipsen announced a definitive agreement to acquire ImCheck Therapeutics, a French biotech focused on next-generation immuno- via butyrophilin targeting, in a transaction valued at up to €1 billion including milestones, aiming to strengthen early-stage assets. These transactions reflect Ipsen's approach to external for pipeline diversification while sharing development risks and costs with partners.
DateTypePartnerValueFocus Area
2013AcquisitionSyntaxinUp to €158M (botulinum toxins)
2016Licensing (Cabometyx)Undisclosed (ex-US/Japan rights)
2022AcquisitionEpizyme$247M
2022PartnershipMarengo TherapeuticsUndisclosedImmuno-oncology
2023AcquisitionAlbireo Pharma$952MRare diseases (liver)
2024LicensingSutro BiopharmaUndisclosed (ADC)
2024LicensingDay One BiopharmaUndisclosed (pediatric)
2025Acquisition (pending)ImCheck TherapeuticsUp to €1BImmuno-oncology

Product Portfolio

Oncology Medicines

Cabometyx (cabozantinib) serves as Ipsen's flagship oncology product, a small-molecule inhibitor targeting multiple receptor tyrosine kinases implicated in tumor angiogenesis, proliferation, and metastasis, including vascular endothelial growth factor receptors (VEGFRs), MET, RET, and the TAM family (TYRO3, AXL, MER). It is approved for advanced renal cell carcinoma (RCC) following prior anti-angiogenic therapy and in combination with nivolumab for first-line treatment of advanced RCC, as well as for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib. In March 2025, the U.S. FDA approved Cabometyx for previously treated neuroendocrine tumors (NETs) regardless of primary tumor site, marking it as the first systemic therapy with such broad indication in that market. The European Commission followed with approval on July 23, 2025, for unresectable or metastatic pancreatic and extrapancreatic NETs in adults previously treated with somatostatin analogs. Efficacy data from the CABINET Phase III trial, which supported the approvals, demonstrated a 77% reduction in the risk of disease progression or death with Cabometyx versus in patients with advanced pancreatic (pNETs) and extra-pancreatic , with median not reached in the Cabometyx arm at final analysis. For RCC and HCC, pivotal trials like and CELESTIAL showed improved and overall survival compared to standard therapies, with from registries indicating consistent outcomes in diverse patient populations, though with higher discontinuation rates due to adverse events like and versus controlled trial settings. Cabometyx has driven significant market impact, contributing to Ipsen's sales growth, with year-to-date 2025 total sales up 12.1% at constant exchange rates through the first nine months, bolstered by expanded indications and uptake in first-line RCC combinations. Somatuline (lanreotide), a somatostatin analog, is approved for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients with unresectable, well- or moderately-differentiated tumors, where it inhibits and tumor growth by binding to somatostatin receptors. The established its efficacy, showing significant prolongation of versus in non-functioning GEP-NETs, with of 0.47 for disease progression or death. Real-world studies have corroborated benefits in delaying progression, particularly in NETs, though with variable response rates influenced by tumor grade and Ki-67 index, and occasional escape phenomena requiring dose escalation. Sales of Somatuline grew in during the first quarter of 2025, aided by shortages of generic lanreotide, contributing to overall therapeutic area momentum despite competitive pressures from generics.

Rare Disease Treatments

Ipsen's portfolio targets genetic-driven conditions in liver and bone disorders, where causal mechanisms such as transport defects or aberrant ossification pathways create profound unmet needs, evidenced by designations from regulatory bodies like the FDA and EMA for indications affecting fewer than 1 in 50,000 individuals. These designations reflect empirical rarity and lack of alternatives, with treatments prioritizing causal intervention over symptomatic relief alone. For instance, progressive familial intrahepatic cholestasis (PFIC) arises from mutations impairing export, leading to intrahepatic accumulation and pruritus, with incidence estimated at 1 in 50,000 to 100,000 births. Similarly, (FOP) involves gene mutations triggering progressive heterotopic ossification, with global prevalence around 1 in 2,000,000. Bylvay (odevixibat), a selective ileal transporter inhibitor, addresses in PFIC and (ALGS) by reducing bile acid reabsorption in the gut, thereby mitigating serum accumulation linked to genetic defects like ABCB11 or JAG1 mutations. Approved by the FDA in 2021 for PFIC and extended to ALGS in 2023, with subsequent approvals in and by 2025, it received orphan designations due to these conditions' rarity—ALGS incidence at approximately 3 in 100,000 live births. Long-term data from extension studies show sustained pruritus reduction and improved in pediatric patients, though access remains constrained by ultra-rare prevalence limiting global patient pools to thousands. Sales reached €135 million in the first nine months of 2025, reflecting 46.4% year-over-year growth at constant exchange rates, fueled by U.S. volume increases from PFIC and ALGS label expansions. In bone disorders, Sohonos (palovarotene), a retinoic acid receptor gamma agonist, represents the first approved therapy for FOP, inhibiting activin A-mediated chondrogenesis to curb flare-up-induced heterotopic ossification. Granted FDA approval in August 2023 following orphan and breakthrough designations, it demonstrated reduced new bone formation volume in clinical trials of adults and children aged 8 and older, addressing the disease's inexorable progression that confines mobility in most patients by adulthood. Patient reach is inherently minimal given FOP's extreme rarity, with fewer than 1,000 confirmed cases worldwide, though real-world registries track outcomes to refine dosing amid risks like premature epiphyseal closure. For (PBC), a cholestatic with autoimmune destruction of affecting roughly 1 in 10,000–20,000 individuals predominantly women, Iqirvo (elafibranor) activates peroxisome proliferator-activated receptors alpha and delta to reduce inflammation and fibrosis. Receiving FDA accelerated approval in June 2024 and EMA conditional approval later that year for use with in non-responders, it showed biochemical improvements in and in phase 3 trials, with exploratory data indicating fatigue and pruritus benefits after up to three years. Orphan status underscores PBC's rarity and progression to without intervention, though post-approval monitoring addresses potential gastrointestinal adverse events. These therapies highlight causal targeting in genetically validated pathways, yet global access challenges persist due to diagnostic delays and specialized administration needs in sparse patient populations.

Neuroscience Therapies

Ipsen's neuroscience therapies primarily feature Dysport (abobotulinumtoxinA), an injectable approved for symptomatic management of through localized muscle relaxation. In adults, Dysport treats cervical dystonia by reducing involuntary neck muscle contractions, with clinical effects typically lasting 12 to 16 weeks based on dosing of 500 units administered intramuscularly into affected muscles. For , it targets upper and lower limb in adults, often post-stroke or due to neurological injury, where doses range from 1,000 to 2,000 units depending on muscle mass and severity, enabling improved and reduced without addressing underlying neurodegeneration. Pediatric approvals extend Dysport's use to children aged two years and older for lower limb , including cases associated with , and upper limb excluding cerebral palsy origins, following FDA endorsements in 2016 and 2019 respectively. Efficacy trials demonstrate statistically significant reductions in Modified Ashworth Scale scores for , with treatment intervals of at least 12 weeks to minimize risks like or injection-site reactions. In post-stroke adult populations, real-world data indicate enhanced rehabilitation outcomes when ultrasound or electrical stimulation guides injections, as shown in the AboLiSh study, which reported improved functional mobility without increased adverse events compared to unguided administration. Neuroscience sales, driven largely by Dysport, grew 9% in the first half of 2025 at constant exchange rates, reflecting sustained demand in and markets amid competitive landscape. Ongoing investigations include Dysport's role in migraine prophylaxis, with phase 3 trials assessing its ability to decrease episodic or chronic headache days via peripheral blockade, though approval remains pending and efficacy data are preliminary relative to established onabotulinumtoxinA precedents. These efforts emphasize incremental symptom relief over curative interventions, aligning with 's mechanism of inhibiting release at neuromuscular junctions.

Business and Financial Performance

Revenue Growth and Key Metrics

In the first nine months of 2025, Ipsen achieved total sales growth of 12.1% at constant exchange rates (CER), or 9.6% as reported, propelled by contributions across its core therapeutic areas including oncology, rare diseases, and neuroscience. This performance prompted an upgrade to full-year 2025 guidance of approximately 10.0% CER sales growth, up from the prior threshold of greater than 7.0%. Year-to-date growth reflected exceptional momentum in rare diseases at 101%, alongside solid advances in oncology (6.6%) and neuroscience (approximately 9%). Historically, Ipsen's revenue trajectory has accelerated through emphasis on high-value specialty medicines, yielding consistent double-digit CER growth in recent periods; for instance, full-year 2024 sales expanded 9.9% at CER to €3,400.6 million, driven by performance in (€1,800+ million), rare diseases, and . This contrasts with earlier dependence on lower-margin generics, as the company's portfolio realignment toward innovative therapies in targeted areas has sustained upward trends, with half-year 2025 sales reaching €1,819.8 million (11.4% CER growth). Key performance indicators underscore : core operating margin guidance for 2025 stands at around 35.0% of total sales, reflecting improved profitability amid investments. expenses in the first half of 2025 totaled €364.9 million, equating to 20.1% of sales, up 12.8% year-over-year to support pipeline advancement. Gross margins improved to 88.6% in the same period, a 2.1 gain, attributable to favorable product mix and cost controls.

Ownership Structure and Shareholding

Ipsen S.A. is primarily controlled by the Beaufour family through affiliated holding companies, which collectively represent the principal shareholders. As of October 14, 2025, these entities hold 52.06% of the and 66.15% of the voting rights, reflecting a structure that amplifies family influence via mechanisms such as double voting rights for long-held shares. This configuration stems from a 2019 reclassification of shares previously held by the family-controlled entity Mayroy S.A., under which Anne Beaufour's Highrock S.à r.l. and Henri Beaufour's Beech Tree S.A. each control approximately 26.03% of the capital and 33.27% of the voting rights. The Beaufour family's stake ensures dominant governance influence, with Anne Beaufour serving as a director representing Highrock S.à r.l. and Beaufour as an representing Beech Tree S.A. on the board. Other notable shareholders include the Schwabe family at 4.577% of shares, often aligned in concert with the Beaufours for strategic decisions. The remaining shares constitute the , with institutional investors holding minority positions such as Investment Management at 0.90% and Fund Advisors at 0.88% as of mid-2025. Ipsen shares trade on under the ticker IPN.PA, with total around 83.8 million and gross voting rights of approximately 131.9 million as of August 2025, accounting for statutory thresholds that exclude certain treasury shares. This concentrated ownership fosters stable, long-term decision-making insulated from short-term activist pressures, though it limits broader shareholder dispersion typical in fully public firms.

Market Position and Competitive Landscape

Ipsen maintains a position as a mid-sized specialty company, with total reaching €3.37 billion in 2024, establishing it as a focused player rather than a broad-market giant in the pharmaceutical sector. Its emphasis on niche therapeutic areas provides competitive advantages in and targeted innovation, though it faces scale limitations compared to larger entities with diversified portfolios and greater R&D resources. In , Ipsen's contributions are concentrated in specific indications like and , where its marketed products generate significant but segment-specific sales, rather than dominating overall revenues led by firms such as and . Key competitors in Ipsen's core domains include , its commercialization partner for (Cabometyx), alongside broader rivals like ( for ) and () in niches, and specialty firms such as Recordati or Chiesi in rare diseases. Larger integrated companies like exert pressure through extensive pipelines and global infrastructure, but Ipsen's partnership model—exemplified by its alliance—mitigates some disadvantages by sharing development costs and expanding market access without sole financial exposure. This approach contrasts with big pharma's internal-heavy strategies, allowing Ipsen to leverage external expertise while avoiding the bureaucratic inertia often critiqued in expansive conglomerates. As of 2025, Ipsen's projected total sales growth of around 10% at constant exchange rates outpaces many peers amid industry-wide challenges, including patent expirations for blockbuster drugs like those affecting Novartis and Pfizer. Oncology sales rose 4.5% in the first nine months of 2025 to €1.91 billion, driven by volume gains in established products, positioning Ipsen to capitalize on underserved niches where larger competitors face resource dilution across broader portfolios. Recent moves, such as the €1 billion acquisition of ImCheck Therapeutics to bolster immuno-oncology capabilities, underscore efforts to deepen competitive edges in emerging modalities against rivals investing in similar next-generation assets. However, dependency on partnerships introduces risks, as shifts in collaborator priorities—evident in past oncology alliance dynamics—could impact market positioning relative to self-sufficient giants.

Corporate Initiatives and Impact

Fondation Ipsen and Philanthropic Efforts

The Fondation Ipsen, operating under the aegis of the Fondation de France since , functions as a non-profit entity dedicated to advancing scientific knowledge in areas aligned with rare diseases, including early detection, , and patient care initiatives. Its mission emphasizes supporting projects in science, , , and , with a strategic focus on rare diseases through awareness-raising, innovation encouragement, and social-educational programs, rather than direct commercial promotion. This structure separates it from Ipsen's core R&D operations, though its priorities overlap with the company's therapeutic areas of , rare diseases, and , fostering indirect alignment via evidence-based collaborations with global experts. Key activities include funding mini- for high-impact projects—51 such have been awarded to support scientific and clinical efforts—and organizing symposia, such as those partnered with institutions like UCSF and LaunchBio, alongside bimonthly webinars in collaboration with Science/AAAS on topics like communities and policy. Outputs manifest in publications from the Fondation Ipsen Press, including free educational books such as Uncovering Rare Disease Volume 4 (2024), Children of Genetics, and Ensemble, as well as periodic issues of The Rare Disease Gazette, which disseminate findings and patient insights without evident ties to product marketing. Awareness efforts extend to events like observances in 25 countries and needs assessments involving 45 organizations, prioritizing practical advancements over self-reported metrics. While these initiatives contribute to biomedical discourse in rare diseases—encompassing subsets relevant to and —the foundation's impact remains challenging to quantify independently, as public data on citation counts, peer-reviewed publications directly attributable to its , or long-term outcomes are limited. No specific awards programs are documented in available records, and evaluations hinge on verifiable activities like grant disbursements rather than intentions, underscoring a philanthropic model that leverages Ipsen's resources for non-commercial scientific exchange. Ties to Ipsen's R&D appear confined to thematic , with funding directed toward independent expert-led efforts grounded in current clinical evidence, avoiding overt promotional integration.

Sustainability, CSR, and Patient Access Programs

Ipsen maintains a sustainability strategy structured around four pillars: environment, patients, people, and governance, emphasizing greenhouse gas reductions and ethical operations. In 2023, the company reported a 36% decrease in Scope 1 and 2 emissions and a 29% reduction in Scope 3 emissions compared to its 2019 baseline, aligning with science-based targets to limit global warming to 1.5°C. Fleet carbon emissions fell by 32% versus 2019, supported by commitments to increase battery electric vehicles in its operations. Ipsen achieved a record-high score in the 2024 S&P Global Corporate Sustainability Assessment, improving by 4 points from prior years, reflecting progress in environmental metrics though self-reported by the company. Under its framework, Ipsen prioritizes integrity across R&D, , and , including initiatives like a Supplier Sustainability Day to address emissions and ethical sourcing. The company aims for a 50% absolute reduction in Scope 1 and 2 emissions by 2030 from 2019 levels, integrating into decisions to minimize environmental impacts and promote responsible practices. These efforts, while advancing operational , occur amid broader scrutiny over R&D prioritization, where high development costs for niche therapies like treatments necessitate pricing strategies that recover investments through limited patient populations. Ipsen's patient access programs, primarily through IPSEN CARES, provide coverage verification, copay assistance, and free medication to eligible patients for products like Somatuline Depot, Dysport, and Bylvay, focusing on insurance navigation and reimbursement support in markets such as the . Early access policies enable compassionate use of investigational drugs prior to regulatory approval where local health authorities permit. An educational initiative launched in October 2025 targets teens and young adults transitioning from pediatric to adult care for rare conditions. However, these programs predominantly serve insured or qualifying patients in high-income settings, while Ipsen's specialty drugs for rare diseases and —such as Somatuline Depot, which has seen per-patient cost increases—face for high that restricts broader global access, particularly in low-resource areas lacking equivalent support, as small market sizes drive premiums to offset R&D expenses.

Controversies and Criticisms

In 2011, the Court of Appeal imposed a €17 million fine on Ipsen for unfair competition practices related to the launch of its drug , determining that the company had engaged in misleading promotional activities against competitor , though this amount was relatively modest compared to multibillion-euro fines levied on other pharmaceutical firms for similar infractions industry-wide. Ipsen has faced ongoing regulatory disputes with the U.S. (FDA) over the classification of Somatuline Depot (), a peptide-based treatment for neuroendocrine tumors approved in 2007. The company argued that the product qualified as a "biological product" under the Biologics Price Competition and Innovation Act due to its complex chain exceeding 40 residues in the final , which would grant 12 years of exclusivity rather than the shorter pathway vulnerable to generics. In , Ipsen sued the FDA after it approved a generic (ANDA) from Invagen Pharmaceuticals and refused to reclassify Somatuline Depot, but federal courts, including the U.S. District Court for the District of Columbia and the D.C. of Appeals in 2024, upheld the FDA's determination that the active ingredient's standalone length—under 40 —dictated status, prioritizing the agency's interpretation of statutory definitions over Ipsen's dosage-form argument. In , Ipsen encountered rejection for palovarotene, an investigational receptor agonist for (FOP), a rare progressive bone disorder. Following a negative opinion from the (CHMP) in May 2023 after re-examination of phase 3 data showing flare-up reduction but concerns over safety in open-label extensions, the declined marketing authorization on July 19, 2023, citing insufficient verification of clinical benefit despite accelerated assessment pathways for orphan drugs. This outcome highlighted regulatory hurdles in approvals, where limited patient pools complicate demonstrating robust efficacy and safety profiles amid high unmet needs. As of October 2025, Ipsen has not faced major new regulatory enforcement actions or fines, with recent filings—such as for Bylvay (odevixibat) in progressive familial intrahepatic cholestasis—progressing to approvals without reported delays, though the sector's stringent evidence requirements continue to pose resolution timelines longer than in non-orphan indications. Ipsen's pricing strategies for treatments targeting rare diseases, such as lanreotide (Somatuline Depot) for neuroendocrine tumors, have drawn criticism from patient advocacy groups for contributing to access barriers, with annual treatment costs often exceeding $100,000 per patient in the U.S. due to orphan drug designations that limit competition and enable premium pricing. These high costs reflect the economic realities of developing therapies for small patient populations, where R&D investments—often in the billions—must be recouped amid high failure rates and regulatory hurdles, as evidenced by the limited success of generic entrants in complex biologics markets. Counterarguments emphasize the empirical value delivered, particularly for oncology products like cabozantinib (Cabometyx), which extends in advanced by approximately 5 months versus best supportive care, yielding an (ICER) of about $206,000 per (QALY) gained in Canadian analyses. In the U.K., initial ICERs exceeded £60,000 per QALY, prompting a voluntary price reduction by Ipsen to align with National Institute for Health and Care Excellence () thresholds, demonstrating responsiveness to health technology assessments while preserving incentives for innovation in areas neglected by generics due to manufacturing complexities and low-volume economics. Historical allegations of aggressive marketing practices include a 2010 U.S. to Ipsen for a on (Increlex) that promoted efficacy claims while omitting critical risks like and neoplasia, potentially misleading physicians on unapproved uses. Similar U.K. Prescription Medicines Authority (PMCPA) rulings in 2018 and 2019 found certain Ipsen materials on and Dysport (abobotulinumtoxinA) to constitute veiled promotion or unsubstantiated comparisons, though no systemic off-label patterns emerged beyond isolated cases. Ipsen maintains a emphasizing ethical promotion and compliance training, with internal reporting mechanisms to mitigate such risks. Patient advocates highlight tensions between affordability demands and the causal necessity of market-driven pricing for sustaining rare disease R&D, where public funding gaps leave private investment as the primary engine; critiques framing high prices as corporate greed overlook evidence that price controls in jurisdictions like correlate with deferred launches and reduced pipeline diversity. Ipsen's patient access programs, including copay assistance and global pricing tiers, address equity concerns, though debates persist on whether these suffice against broader systemic pressures favoring over immediate cost containment. An isolated 2024 insider trading case involving an Ipsen director profiting $262,000 from non-public information on the Epizyme acquisition underscored individual ethical lapses in market conduct, prompting enhanced compliance but not indicative of firm-wide policy failures.

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