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.
Ipsen has secured global rights to develop and commercialize GENFIT's innovative treatment, elafibranor, aimed at Primary Biliary Cholangitis (PBC). The agreement provides GENFIT with an upfront payment of €120 million and potential milestone payments totaling €360 million, alongside royalties up to 20%. Ipsen will also acquire an 8% equity stake in GENFIT through a €28 million investment. The Phase III trial, ELATIVE™, is ongoing, with top-line data expected in early 2023, presenting a significant opportunity for both companies in addressing unmet medical needs in liver diseases.
Ipsen released regulatory news on November 30, 2021, detailing its share capital structure. The total number of shares comprising the share capital is 83,814,526. The gross total of voting rights stood at 132,128,427, while the net total, after excluding non-voting shares, was 130,814,971. This information is in compliance with the French Commercial Code and the regulations of the Autorité des Marchés Financiers.
Ipsen announced the total number of shares and voting rights on 31 October 2021. The total number of shares composing the share capital is 83,814,526. The gross total of voting rights stands at 132,139,463, while the net total of voting rights is 130,824,193. This update is in accordance with the French Commercial Code, emphasizing the necessity to declare threshold crossing in compliance with legal requirements.
Ipsen has appointed Stewart Campbell as Executive Vice President and President of North America, effective immediately. He will lead Ipsen's operations in the US and Canada and will report to CEO David Loew. Campbell, who joined Ipsen in 2021, brings over 20 years of pharmaceutical experience, including significant roles at Roche/Genentech. His leadership is expected to enhance Ipsen's growth in North America as the company continues to execute its new group strategy aimed at improving patient outcomes.
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Ipsen (Euronext: IPN; ADR: IPSEY) reported strong sales for Q3 2021, achieving total sales of €727.4 million, up 14.9% year-over-year. Year-to-date sales reached €2,077.7 million, a 9.3% increase. Specialty Care sales grew 12.5% to €1,912.3 million, driven by Somatuline, Cabometyx, and Dysport. Consumer Healthcare also saw a 9.8% rise. Full-year sales growth guidance is upgraded to over 11.0% from 8.0%. Despite a regulatory setback for palovarotene, business development remains strong, evidenced by recent collaborations in Oncology and Neuroscience.
Ipsen has secured an exclusive worldwide license with Accent Therapeutics to develop and commercialize a pre-clinical METTL3-inhibitor program, targeting acute myeloid leukemia (AML). This collaboration enhances Ipsen's oncology pipeline and expands its focus on hematological malignancies. Ipsen will invest up to $446 million, including upfront and milestone payments, plus royalties. This agreement aligns with Ipsen's mission to address high unmet medical needs in oncology, specifically for rare cancers.
Ipsen has appointed Mari Scheiffele as Executive Vice President and President of Specialty Care International, effective November 1, 2021. Scheiffele, with 20 years of healthcare experience, will focus on enhancing Ipsen's commercial presence across 115 countries, excluding North America. Previously at Novartis, she spearheaded business transformations in oncology and specialty care. Her diverse expertise is expected to drive growth in Ipsen's oncology, rare disease, and neuroscience sectors. Scheiffele holds a doctorate in neuroscience from Harvard Medical School.
On September 30, 2021, Ipsen reported a total of 83,814,526 shares in its share capital. The gross total of voting rights stood at 132,142,666, while the net total was 130,824,427. This announcement aligns with regulatory requirements under the French Commercial Code and the Autorité des Marchés Financiers.
Additionally, there exists a statutory clause requiring the declaration of threshold crossing, ensuring compliance with legal thresholds.
Ipsen announced the validation of its submission for an indication extension of Cabometyx (cabozantinib) by the European Medicines Agency in August 2021. The pivotal COSMIC-311 trial demonstrated a significant progression-free survival (mPFS) increase of 78% versus placebo in patients with radioactive iodine-refractory differentiated thyroid cancer. Additional data from related trials presented at the European Society for Medical Oncology Congress reinforced Cabometyx's efficacy across different cancers, including metastatic castration-resistant prostate cancer.