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 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.
Ipsen has reported as of 31 August 2021, the company has 83,814,526 shares comprising its share capital. The gross total of voting rights is 132,142,743, while the net total stands at 130,832,105. These figures include shares that hold double voting rights and exclude shares without voting rights. Ipsen is listed on Euronext Paris under the ISIN Code FR 0010259150.
On August 23, 2021, Ipsen reported several share transactions under its share buyback program. The daily trading volume included 22,594 shares at an average price of €83.3407 on XPAR, and 5,558 shares at €83.2706 on CEUX. Additional trades included 1,830 shares at €83.5098 and 2,018 shares at €83.2216. Transactions continued on August 24 with a total of 17,901 shares at €83.7122 on XPAR. The report details multiple transactions throughout these dates, providing information on daily volumes and prices.
The press release details Ipsen's stock transactions on August 16-20, 2021, listing daily volumes and average prices. On August 16, 2021, Ipsen reported a total volume of 25,270 shares at an average price of €82.6287. Subsequent transactions showed fluctuations in volume and price, with notable sales on August 17 (15,100 shares at €83.6661) and August 18 (10,141 shares at €84.0074). The total volume for the week reached 116,383 shares, with an average price of €83.0762, reflecting active trading during this period.
Ipsen (Euronext: IPN; ADR: IPSEY) has announced the withdrawal of its New Drug Application (NDA) for palovarotene after discussions with the U.S. FDA. This decision comes as additional data analyses from the Phase III MOVE program are required, preventing completion within the current review cycle. Ipsen plans to resubmit the NDA following these analyses. Palovarotene is being developed as a treatment for fibrodysplasia ossificans progressiva (FOP), a rare genetic disorder characterized by abnormal bone formation.
Ipsen and Exicure Inc. have entered a collaboration to develop novel Spherical Nucleic Acids (SNAs) targeting Huntington’s disease and Angelman syndrome. Ipsen will pay Exicure $20 million upfront, with potential for up to $1 billion in milestone payments and royalties. SNAs are expected to enhance drug delivery to hard-to-reach areas like the brain. Both diseases currently lack approved disease-modifying therapies, presenting a significant market opportunity. The partnership aims to leverage Ipsen's expertise in neuroscience and Exicure's innovative delivery technology to address these unmet medical needs.
Ipsen (ADR: IPSEY) reported a strong financial performance for H1 2021, with total sales of €1,350.3 million, marking an 11.0% growth at constant exchange rates. Core operating income rose to €479.8 million (up 17.0% from H1 2020), with a core operating margin of 35.5%. Specialty Care sales increased by 11.2% to €1,244.5 million, while Consumer Healthcare grew by 8.6%. The company upgraded its FY 2021 guidance, expecting sales growth>8.0%. Net debt reduced significantly to €336.5 million, a decrease of €188.7 million from December 2020.