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 announced its collaboration with Exelixis in the COSMIC-311 Phase III trial, evaluating Cabometyx for treating radioiodine-refractory differentiated thyroid cancer (DTC). This trial has shown promising results, meeting its co-primary endpoint by demonstrating significant improvement in progression-free survival. Ipsen aims to utilize these results for future regulatory submissions. FDA has previously granted Breakthrough Therapy Designation for Cabometyx in this indication. The trial, involving around 300 patients, is set for detailed results presentation at the upcoming ASCO Annual Meeting.
Ipsen announced its Q1 2021 sales results with total sales reaching €658.5 million, reflecting a growth of 0.6% as reported and 5.5% at constant exchange rates (CER). A notable increase of 6.4% in Specialty Care sales to €611.5 million was driven by strong performances of key products like Cabometyx and Somatuline. Conversely, Consumer Healthcare faced a decline of 5.4% to €47.0 million due to ongoing pandemic effects. The company confirmed its FY 2021 guidance, anticipating over 4% sales growth at CER.
Fusion Pharmaceuticals has successfully acquired Ipsen's intellectual property related to IPN-1087, a small molecule targeting neurotensin receptor 1 (NTSR1), to develop a new alpha-emitting radiopharmaceutical, FPI-2059.
The acquisition involved issuing 600,000 shares of common stock to Ipsen and potential milestone payments up to €67.5 million, plus royalties on future sales. This move signals Fusion's commitment to advancing targeted therapies for various solid tumors and enhancing its oncology pipeline.
Ipsen announced that the European Commission has approved Cabometyx in combination with Opdivo for the first-line treatment of advanced renal cell carcinoma (aRCC). This marks Cabometyx's first European approval for use with another therapy and its third indication for renal cell carcinoma. The decision is based on results from the Phase III CheckMate -9ER trial, demonstrating significant improvements in median progression-free survival, overall survival, and objective response rate compared to sunitinib. The approval applies across all EU member states.
Fusion Pharmaceuticals has announced an agreement to acquire Ipsen's IPN-1087, a small molecule targeting neurotensin receptor 1 (NTSR1) in solid tumors. This acquisition aims to develop FPI-2059, an alpha-emitting radiopharmaceutical designed to target tumors overexpressing NTSR1. Fusion will issue 400,000 shares to Ipsen upon closing and up to €67.5 million in development milestones. Ipsen will receive royalties on future net sales and further milestone payments totaling €350 million.
The acquisition is set to diversify Fusion's pipeline, potentially advancing treatments for colorectal cancer and pancreatic ductal adenocarcinoma.
Ipsen (Euronext: IPN; ADR: IPSEY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Cabometyx® in combination with Opdivo® for treating advanced renal cell carcinoma (aRCC). The European Commission will review this recommendation, with a final decision expected soon. This follows successful results from the Phase III CheckMate -9ER trial, showing significant improvements in progression-free survival and overall survival compared to sunitinib.
Ipsen announced nine abstracts focused on neuroendocrine tumors (NETs) during the ENETS Conference, including data from the CLARINET FORTE study. This study showed no deterioration in patients' quality of life (QoL) when treated with lanreotide autogel. Pharmacokinetic data confirmed proportional increases with higher dosing without additional safety concerns. Additionally, an economic model indicated potential healthcare savings in the UK by increasing independent home administration of lanreotide, reducing nurse visits and costs by 16.4%.
Ipsen reported its 2020 financial results, achieving €2.592 million in sales, a 3.0% increase at constant currency. Specialty Care sales grew by 5.9%, while Consumer Healthcare declined by 21.3% due to COVID-19. Core Operating margin improved to 32.0%, with a net profit of €610.5 million, reflecting an 8.4% increase. Free Cash Flow rose significantly to €646.4 million, aided by operational efficiencies. The company set a 2021 sales growth guidance of over 4.0% and proposed a dividend of €1.00 per share. Ipsen emphasizes its ongoing focus on oncology and external innovations.
Ipsen (Euronext: IPN; ADR: IPSEY) announced it will present new data at the ASCO GU Symposium from February 11-13, 2021. The focus will be on ten abstracts related to genitourinary cancers, highlighting treatment advancements. Key findings include extended data from the CheckMate -9ER trial demonstrating that cabozantinib combined with nivolumab may improve survival for advanced renal cell carcinoma (RCC) patients. Significant real-world evidence also suggests cabozantinib offers higher response rates compared to other TKIs in metastatic RCC cases.
Ipsen has appointed Gwenan White as Executive Vice President, Communications and Public Affairs, effective March 2021. She will oversee global communications and report to CEO David Loew, contributing to the company's strategy, Focus. Together. For patients & society. White has extensive experience in communications from her previous role at Novartis and will strengthen Ipsen’s global stakeholder relationships. This leadership change aims to enhance the visibility of Ipsen's innovative medicines and align communications with strategic goals.