Articles from Ipsen Pharma

PARIS, FRANCE, March 12th, 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty care-driven company, announced today the appointment of Olivia Brown as, EVP, Global Head of Neurotoxins, effective April 1st, 2025.  She will serve on Ipsen’s Executive Leadership Team (ELT) and report directly to Chief Executive Officer David Loew. In this newly created role, she will lead Ipsen’s global neurotoxins franchise, overseeing strategy and execution across both therapeutic and aesthetic indications.

PARIS, FRANCE, 13 February 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the full year 2024.

PARIS, FRANCE; 03 December 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Biomunex Pharmaceuticals today announced an exclusive global licensing agreement for BMX-502. BMX-502 is a bispecific antibody that engages and activates a subset of cytotoxic T cells called Mucosal-Associated Invariant T cells (MAIT cells) and targets the GPC3 tumor antigen, to kill cancer cells. GPC3 is a clinically validated target, highly expressed across several cancer types.1 MAIT cells are present throughout the body, highly enriched in many specific tissues of the body, particularly in mucosal and barrier tissues. BMX-502 offers a promising approach to treating tumors in these tissues.2,3

PARIS, FRANCE, 18 November, 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced data at the American Association for the Study of Liver Diseases (AASLD) assessing the long-term efficacy and safety of patients treated with Bylvay® from two Phase III open-label extension studies: late-breaking abstract (#5045) on PEDFIC 2 in Progressive Familial Intrahepatic Cholestasis (PFIC) and oral presentation ASSERT-EXT (#50) in Alagille syndrome (ALGS). Sustained efficacy data and improvements in height, weight and sleep measures were observed for patients treated with Bylvay for at least 72 weeks in both rare cholestatic diseases.

PARIS, FRANCE, 15 November 2024 Ipsen (Euronext: IPN; ADR: IPSEY) announced today late-breaking data for Iqirvo® (elafibranor 80 mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE® study at the American Association for the Study of Liver Disease (AASLD) congress. The late-breaking presentations (Abstract #5041 and Abstract #5042) report on biomarkers of cholestasis, stabilization of surrogate markers of liver fibrosis and moderate-to-severe pruritus data for up to three years in Iqirvo-treated patients. Additionally, exploratory endpoints in fatigue and sleep were evaluated using patient-reported outcomes tools.

PARIS, FRANCE, 23 October 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its performance for the year to date and the third quarter of 2024.

PARIS, FRANCE, 14 October 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that its Dublin, Ireland production site has received the Shingo Prize for operational excellence. This is Ipsen’s second Shingo Prize, with its site in Signes, France, receiving the first award in 2020.

                                                                

PARIS, FRANCE, 20 September 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has conditionally approved Iqirvo® (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist, that exerts an effect on the proteins PPARα and PPARδ, thought to be key regulators of bile acid, inflammation and fibrosis.

PARIS, FRANCE, 16 September 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today final data from the CABINET Phase III trial investigating Cabometyx® (cabozantinib) versus placebo in people living with advanced pancreatic neuroendocrine tumors (pNETs) or advanced extra-pancreatic neuroendocrine tumors (epNETs) whose disease had progressed after prior systemic therapy. These data demonstrated a statistically significant reduction in the risk of disease progression or death for Cabometyx versus placebo of 77% (hazard ratio (HR) 0.23) and 62% (HR 0.38) for people living with advanced pNETs and epNETs, respectively.1,2 Presentation of these data is taking place today at the 2024 European Society for Medical Oncology Congress (ESMO 2024) during the Proffered Paper Session: NETs and Endocrine Tumors at 2:45 p.m. CEST, and is published in the New England Journal of Medicine (NEJM).

PARIS, FRANCE, 15 September 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today detailed final overall survival (OS) data from the Phase III CONTACT-02 trial investigating the combination of Cabometyx® (cabozantinib) and atezolizumab in metastatic castration-resistant prostate cancer (mCRPC). The trial investigated the combination regimen versus a second novel hormonal therapy (NHT) in men previously treated with one NHT and measurable soft-tissue disease. At a median follow-up of 24.0 months, these data demonstrated a numerical but not statistically significant improvement in OS for the combination versus a second NHT (hazard ratio: 0.89; 95% confidence interval: 0.72-1.10; P=0.296). As previously announced, the trial met the other primary endpoint of progression-free survival (PFS), demonstrating a statistically significant benefit in PFS.1 Safety for the combination appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified.

Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases

PARIS, FRANCE, 25 July 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the first half of 2024.

PARIS, FRANCE, 11 July 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Foreseen Biotechnology (Foreseen) today announced an exclusive global licensing agreement for FS001, an antibody-drug conjugate (ADC) with first-in-class potential. FS001 targets a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis. This novel tumor antigen was identified using Foreseen’s high throughput, integrated translational proteomics, and artificial intelligence (AI)-powered screening platforms, to analyze their vast collection of well-characterized clinical tumor samples. FS001 utilized an innovative, stable and cleavable linker coupled to a potent topoisomerase I inhibitor. Preclinical efficacy of FS001 was demonstrated in multi-drug resistant cancer models. The agreement gives Ipsen exclusive worldwide rights to develop, manufacture and commercialize FS001.

PARIS, FRANCE, 2 July 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today confirmation of an expanded collaboration and license agreement with Exelixis, Inc. for the development of Cabometyx® (cabozantinib) in advanced pancreatic neuroendocrine tumors (pNETs) and advanced extra-pancreatic neuroendocrine tumors (epNETs). The agreement is based on positive outcomes from the CABINET Phase III trial, led by the Alliance for Clinical Trials in Oncology and sponsored by the National Cancer Institute (NCI), which investigated Cabometyx versus placebo in people living with advanced pNETs or advanced epNETs whose disease had progressed after prior systemic therapy. An independent Data and Safety Monitoring Board recommended to stop accrual to the study, unblind patients and allow crossover from placebo to Cabometyx. This was due to early efficacy demonstrated at an interim analysis in both of the trial’s cohorts, with clinically meaningful improvements in progression-free survival (PFS).1

                                                                        

PARIS, FRANCE, and CAMBRIDGE, MA, U.S., 07 June 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Marengo Therapeutics Inc, a clinical-stage biotech company, announced today the expansion of their ongoing oncology research partnership, to include TriSTAR, Marengo’s next-generation, precision T cell engager (TCE) technology. Traditional TCEs targeting ‘cold’ tumors have limited efficacy due to poor T cell quality and exhaustion. Marengo’s proprietary first-in-class TriSTAR TCEs have the potential to overcome these limitations, redirecting a new and expanded pool of highly activated memory Vβ T cells to the tumor. The teams will focus on exploring potential in ‘cold’ tumors which typically fail to trigger a strong immune response when treated with TCEs.

PARIS, FRANCE, 06 June 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, announced today the appointment of Josep Catllà as EVP, Chief Corporate Affairs Officer, effective August 19, 2024. He will serve on the Executive Leadership Team (ELT) and report directly to Ipsen’s Chief Executive Officer (CEO), David Loew.

PARIS, FRANCE, DD June 2024 Ipsen (Euronext: IPN; ADR: IPSEY) today announced new late-breaking data at the European Association for the Study of the Liver (EASL) Congress demonstrating the enduring efficacy of elafibranor in managing disease progression after 78 weeks of treatment. In the variable double-blind period of the ELATIVE® Phase III trial in primary biliary cholangitis (PBC), the potential for elafibranor to improve itch-related quality of life (QoL) as measured by the itch domain of the PBC-40 and the 5-D Itch questionnaire was also demonstrated. Elafibranor is a novel, potential first-in-class, PPAR agonist. It is currently under review by the U.S. Food and Drug Administration, the European Medicines Agency and the UK Medicines and Healthcare Products Regulatory Authority.

PARIS, FRANCE, 2 May 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, announced today the appointment of Keira Driansky as EVP, President of North America, effective May 13, 2024. She will serve on the Executive Leadership Team (ELT) and report directly to Ipsen’s Chief Executive Officer (CEO), David Loew.

PARIS, FRANCE, 24 April 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its sales for the first quarter of 2024.

PARIS, FRANCE; BOSTON, U.S., 22 April 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Skyhawk Therapeutics today announced the signing of an exclusive worldwide collaboration to discover and develop novel small molecules that modulate RNA for rare neurological diseases. The agreement includes an option pursuant to which Ipsen would acquire exclusive license for the worldwide rights to develop successful development candidates (DC). Following successful DC nomination, Ipsen will be responsible for all activities. Skyhawk’s unique platform accelerates building RNA-targeting small molecules across several therapeutic areas, including rare neurological diseases.2

PARIS, FRANCE; SAN FRANCISCO, U.S., 02 April 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Sutro Biopharma (NASDAQ: STRO, “Sutro”, “the Company”) today announced an exclusive global licensing agreement for STRO-003. STRO-003, an antibody-drug conjugate (ADC) in the final stages of pre-clinical development, targets the ROR1 tumor antigen which is known to be overexpressed in many different cancer types including solid tumors and hematological malignancies.1 The agreement gives Ipsen exclusive worldwide rights to develop and commercialize STRO-003 and will be the first ADC candidate joining Ipsen’s expanding portfolio.

PARIS, FRANCE, 13 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

PARIS, FRANCE, 8 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the year and final quarter of 2023.

PARIS, FRANCE, 7 December 2023 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, today holds its Capital Markets Day in London, U.K.

PARIS, FRANCE, 13 November, 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced full results from the pivotal Phase III ELATIVE® trial, which are being presented in a late-breaking oral session (Abstract #484, Monday, 13 November at 16.45 EST) at the American Association for the Study of Liver Disease (AASLD) and simultaneously published in the New England Journal of Medicine (NEJM). This trial evaluated the efficacy and safety of investigational elafibranor, an oral, dual PPAR α,δ agonist, as a potential novel class of treatment for patients with the rare, autoimmune cholestatic liver disease, primary biliary cholangitis (PBC).

Paris (France), 26 October 2023

PARIS, FRANCE, 23 October 2023 – Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) confirmed its negative opinion recommending not to maintain the orphan designation for Bylvay® (odevixibat) in Alagille syndrome (ALGS). This is despite a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2023. Orphan designation has a strong influence on the reimbursement mechanisms and access for patients to medicines in some countries in the E.U. In order to maintain Bylvay’s orphan designation in the approved treatment of progressive familial intrahepatic cholestasis (PFIC), Ipsen is planning to resubmit to the EMA under a new brand name for the treatment of ALGS by the end of 2023.

PARIS, FRANCE, 3 October 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that its partner Galderma has confirmed receipt from the FDA of a Complete Response Letter related to its Biologics License Application for liquid botulinum toxin type A (QM-1114), noting certain deficiencies related to chemical, manufacturing and controls (CMC) processes.

PARIS, FRANCE, 4 September 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today the co-optation of Pascal Touchon to its Board as an independent director, effective 4 October 2023, following the decision of Paul Sekhri to step down from his director role on this date due to other professional commitments.

 PARIS, FRANCE, 1 September 2023 – Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, announced today the appointment of Christelle Huguet as Executive Vice President, Head of Research and Development. She will succeed Howard Mayer, EVP and Head of R&D, who will leave Ipsen on September 22, following his decision to retire.

– Cabozantinib in combination with atezolizumab demonstrated a statistically significant reduction in the risk of disease progression or death compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer 

PARIS, FRANCE, 16 August 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today approval by the U.S. Food and Drug Administration (FDA) of Sohonos™ (palovarotene) capsules as a retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP).

Paris, France: 27 July 2023Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, presents today its financial results for the first half of 2023.

PARIS, FRANCE, 24 July 2023 – Ipsen (Euronext: IPN: ADR: IPSEY) announced today that the Board of Directors of Ipsen has been informed of certain changes of the shareholders’ agreements relating to the concert of its principal shareholders.

PARIS, FRANCE, 21 July 2023 – Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Bylvay® (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged six months or older.

PARIS, FRANCE, 21 July 2023 – Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Bylvay® (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged six months or older.

PARIS, FRANCE, 19 July 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has followed guidance provided by the Committee for Medicinal Products for Human Use (CHMP) in May this year, and has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). Palovarotene is the first treatment to be submitted anywhere in the world for regulatory approval for FOP, an ultra-rare disease with approximately 900 known cases worldwide.

PARIS, FRANCE, 30 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced positive topline data from the pivotal ELATIVE Phase III trial. In the trial the efficacy and safety of elafibranor, an investigational dual α,δ PPAR agonist, is being assessed for the treatment of patients with the rare cholestatic liver disease, primary biliary cholangitis (PBC), who have an inadequate response or intolerance to the current standard of care therapy, ursodeoxycholic acid (UDCA).

PARIS, FRANCE, 29 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). The FDA is currently reviewing the New Drug Application (NDA) for palovarotene with a decision anticipated by August 16, 2023. If approved, palovarotene will be the first treatment in the U.S. for FOP.

PARIS, FRANCE, 14 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The review is based on positive results from the pivotal Phase III NAPOLI 3 trial, in which the Onivyde regimen demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS), compared to nab-paclitaxel plus gemcitabine, with a safety profile consistent with the profiles of the treatment components. These results were presented at the January 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).

PARIS, FRANCE, 14 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) Onivyde® (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The review is based on positive results from the pivotal Phase III NAPOLI 3 trial, in which the Onivyde regimen demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS), compared to nab-paclitaxel plus gemcitabine, with a safety profile consistent with the profiles of the treatment components. These results were presented at the January 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).

PARIS, FRANCE, 13 June 2023 – Ipsen (Euronext: IPN: ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has approved Bylvay® (odevixibat) for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome (ALGS). Bylvay is a once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure. Bylvay was approved as the first drug treatment option for patients living with cholestatic pruritus due to progressive familial intrahepatic cholestasis (PFIC) in the U.S., and for the treatment of PFIC in Europe, in 2021. Bylvay is immediately available via prescription for eligible ALGS patients.

PARIS, FRANCE, 12 June 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the company will present data from across its growing rare liver disease portfolio, at the European Association for the Trial of Liver (EASL) Congress 2023, 21-24 June in Vienna, Austria. These include seven abstracts on new clinical data being presented on Bylvay® (odevixibat) when used in patients with progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS). In addition, an abstract on content validation of patient-reported outcomes assessment tools, used with patients with primary biliary cholangitis (PBC), is being presented.

PARIS, FRANCE, 26 May 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the re-examination of palovarotene as a potential treatment for the ultra-rare bone disease, fibrodysplasia ossificans progressiva, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency confirms the negative opinion given in January 2023. Palovarotene is the first medicine to be submitted for regulatory approval for FOP. The only treatments currently available in the E.U. are for managing the symptoms caused by FOP, such as inflammation and chronic pain and not the underlying disease.

PARIS, FRANCE, 17 May 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced that new data from its growing rare disease portfolio will be presented at the 55th Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), taking place in Vienna, Austria 17-20 May 2023. The six data presentations, made up of four oral, one poster, and one e-poster, consistently demonstrate the efficacy and tolerability of investigational Bylvay® (odevixibat) for the potential treatment of cholestatic liver disease patients with Alagille syndrome (ALGS) and the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).

Ipsen delivers robust sales growth in the first quarter of 2023 and confirms its full-year guidance

Ipsen appoints Sandra Silvestri as EVP, Chief Medical Officer and Head of Global Medical Affairs, Patient Safety and Patient Affairs

  

 Ipsen completes acquisition of Albireo, expanding the scope of its Rare Disease portfolio

Ipsen extends expiration date of tender offer for Albireo Pharma, Inc. to 1 March 2023

             Ipsen, Université de Montréal and IRICoR broaden existing oncology partnership, with an exclusive license agreement and two new discovery-stage programs

PARIS, FRANCE Ipsen (Euronext: IPN; ADR: IPSEY) today announced three-year minimum, 44-month median, follow-up results from the Phase III CheckMate -9ER trial showing that Cabometyx® (cabozantinib) in combination with nivolumab provides survival and response rate benefits after three-years in the first-line treatment of advanced renal cell carcinoma (aRCC), compared to sunitinib.1 These findings are being presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) from 16–18 February 2023.

Paris (France), 9 February 2023Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, presents today its financial results for the year and the fourth quarter of 2022.