Welcome to our dedicated page for IPSEN SA news (Ticker: IPSEY), a resource for investors and traders seeking the latest updates and insights on IPSEN SA stock.
Ipsen SA (ADR: IPSEY) generates a steady flow of news centered on its activities as a global, mid-sized biopharmaceutical company focused on Oncology, Rare Disease and Neuroscience. This news page aggregates company announcements, partner releases and regulatory updates that mention Ipsen and its ADR program, giving readers a focused view of developments that can influence perceptions of IPSEY.
Recent news highlights Ipsen’s role in advancing specialty care medicines. In oncology, the company has reported Phase III NAPOLI 3 trial results for an investigational Onivyde-based regimen (NALIRIFOX) in previously untreated metastatic pancreatic ductal adenocarcinoma, with statistically significant improvements in overall and progression-free survival compared to a nab-paclitaxel plus gemcitabine regimen. Ipsen has also nominated a first clinical drug candidate from its multi-year oncology collaboration with Marengo Therapeutics, based on Marengo’s STAR T cell activator platform for solid tumors.
In rare diseases, news items cover Ipsen’s work in pediatric cholestatic liver diseases and ultra-rare conditions. Examples include Health Canada’s approval of Bylvay (odevixibat) for pruritus due to Progressive Familial Intrahepatic Cholestasis, under a partnership with Medison Pharma, and regulatory interactions for palovarotene in fibrodysplasia ossificans progressiva, including a CHMP negative opinion and a U.S. FDA Complete Response Letter. Corporate news also details Ipsen’s agreement to acquire Albireo, adding Bylvay and other bile acid modulators to its rare disease portfolio.
Neuroscience and rare neurological disease updates feature Ipsen’s collaboration with Skyhawk Therapeutics to discover RNA-targeting small molecules for rare neurological diseases. Partner announcements describe Ipsen’s option to obtain exclusive global rights to development candidates and its responsibility for later-stage development and commercialization.
Investors and observers can use this news feed to follow Ipsen’s clinical trial readouts, regulatory decisions, licensing deals, acquisitions and capital markets disclosures that reference IPSEY. Regularly reviewing these updates can help contextualize the company’s therapeutic focus and strategic direction as reflected in public announcements.
The Combined Shareholders’ Meeting of Ipsen (Euronext: IPN; ADR: IPSEY) approved all 20 resolutions, including a dividend payment of €1.20 per share, effective from 2 June 2022, with an ex-date of 31 May 2022. The meeting, chaired by Mr. Marc de Garidel, also appointed PricewaterhouseCoopers Audit as the new Statutory auditor, replacing Deloitte & Associés. Key discussions included the company's strategy and 2021 financial performance.
On May 24, 2022, IPSEN proposed a share repurchase program to its shareholders, requesting authorization to repurchase up to 10% of its total shares (approx. 8.4M shares). The program aims to enhance market liquidity, retain shares for potential mergers or employee stock plans, and possibly cancel acquired shares. The maximum repurchase price is set at €200 per share, with a theoretical total of €1.68 billion dedicated to this initiative over 18 months. This authorization will replace a prior 2021 approval.
Ipsen released an update regarding its share capital on 30 April 2022. The total number of shares is reported at 83,814,526, leading to a gross total of voting rights amounting to 132,068,424. The net total of voting rights, which excludes shares without voting rights, stands at 130,792,368. This information complies with the regulatory requirements set forth by the French Commercial Code and the Autorité des Marchés Financiers.
The Shareholders of Ipsen are invited to the Combined Shareholders’ Meeting on 24 May 2022 at 3:00 p.m. in Paris. Important resolutions include the approval of a €1.20 dividend per share for FY2021, with an ex-date of 31 May 2022 and payment on 2 June 2022. The meeting's preliminary notice was published on 15 April 2022, and final details will be available on Ipsen's website. The company remains focused on transformative medicines across Oncology, Rare Disease, and Neuroscience with €2.6bn in Specialty Care sales for FY2021.
Ipsen has received European Commission approval for Cabometyx (cabozantinib) as a monotherapy for adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC) who are refractory to radioactive iodine. This approval is significant as it represents the first second-line treatment option in Europe for this rare cancer. Cabometyx showed a 78% reduction in risk of disease progression or death compared to placebo in the COSMIC-311 Phase III trial, confirming its efficacy. There are currently limited treatment options for patients in this category.
Ipsen (ADR: IPSEY) reported a strong Q1 2022 total sales performance of €687.9m, up 12.5% from the previous year, with core drivers including Decapeptyl, Dysport, Cabometyx, and Onivyde showing double-digit growth. However, Somatuline sales remained flat due to increased competition and generic market entries. The company confirmed its full-year guidance, anticipating total sales growth above 2% at constant exchange rates. Ipsen is in negotiations to divest its Consumer HealthCare business, expected to finalize by Q3 2022, further focusing on Specialty Care.
Ipsen announced the filing of its 2021 Universal Registration Document with the French Autorité des Marchés Financiers on 12 April 2022, registered under number D.22-0283. The document is available on ipsen.com and includes the Annual Financial Report and the Board of Directors’ Report on Corporate Governance. With total sales of €2.9bn in FY 2021, Ipsen specializes in transformative medicines across Oncology, Rare Disease, and Neuroscience, with operations in over 100 countries.
The recent press release from Ipsen, dated March 31, 2022, provides critical information regarding its share capital and voting rights. As of the stated date, Ipsen's total number of shares is 83,814,526, leading to a gross total of voting rights of 132,085,237. The net total of voting rights stands at 130,826,088, considering shares without voting rights. This data is crucial for investors who monitor shareholder dynamics and voting power within the company.
Ipsen announced a positive recommendation from the European Medicines Agency's CHMP for Cabometyx as a treatment for locally advanced or metastatic differentiated thyroid cancer (DTC) in adults. This recommendation is based on the COSMIC-311 Phase III trial, where Cabometyx showed a 78% reduction in disease progression or death compared to placebo. The objective response rate was 15% for Cabometyx versus 0% for placebo. This follows prior FDA approval in September 2021. Cabometyx is marketed in over 60 countries worldwide, addressing a critical need for new treatment options.
Ipsen has announced the development of a new electronic autoinjector for Somatuline Autogel/Somatuline Depot, aiming to enhance the patient experience for those with gastroenteropancreatic neuroendocrine tumors, carcinoid syndrome, or acromegaly. The device, built in partnership with Phillips-Medisize, is part of a €60 million investment in innovation and manufacturing. Performance and safety studies are ongoing, with the first launches expected in 2024. This fourth-generation device promises improved injection comfort for patients and caregivers.