IPSEN SA S/ADR - IPSEY STOCK NEWS

Exelixis and Ipsen announced that the COSMIC-312 phase 3 trial of cabozantinib combined with atezolizumab for advanced hepatocellular carcinoma met its primary endpoint, showing a 37% reduction in disease progression or death versus sorafenib (HR: 0.63; P=0.0012). However, the interim analysis for overall survival did not reach statistical significance, prompting concerns about the likelihood of positive final results. Safety profiles remained consistent with known data, and Exelixis plans to discuss the findings with the FDA, while results are expected in early 2022.

Ipsen (ADR: IPSEY) presented findings from a U.S. healthcare database analysis at the ISPRM 2021 Congress, focusing on treatment patterns for adults with spasticity. The study highlighted that only 4% of patients in the MarketScan database and 3% in the IQVIA database received botulinum neurotoxin type A (BoNT-A), the recommended first-line treatment. This raises concerns regarding access to treatment, particularly in the context of the COVID-19 pandemic's impact on care. Ipsen's leadership emphasized the need for innovative solutions to bridge the gap between clinical guidelines and patient experiences.

Exelixis and Ipsen announced positive results from the phase 3 COSMIC-311 trial of cabozantinib (CABOMETYX) for radioactive iodine-refractory differentiated thyroid cancer. The trial met its co-primary endpoint, showing a 78% reduction in disease progression risk compared to placebo. Median progression-free survival was not reached for cabozantinib, while it was 1.9 months for placebo. A supplemental New Drug Application has been submitted to the FDA for expanded use of CABOMETYX. The safety profile was consistent with previous findings, with a 5% discontinuation rate due to adverse events.

Ipsen (ADR: IPSEY) has launched its third Employee Shareholding plan aimed at engaging employees in its global operations across 21 countries. The offering involves existing shares capped at 1% of the company’s capital, with a subscription price of €66.10, reflecting a 20% discount from the average price on Euronext Paris. This plan is available to employees with at least three months of seniority and includes an employer matching contribution. Shares will be locked for five years, ensuring employee commitment to the company's long-term growth.

Ipsen (ADR: IPSEY) announced the FDA's acceptance of its New Drug Application (NDA) for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva (FOP). The NDA is based on the MOVE trial, showing a 62% reduction in new HO volume in treated patients. FOP is an ultra-rare genetic disorder affecting 1.36 per million individuals, causing debilitating new bone formation. The FDA's target action date is November 30, 2021. Ipsen aims to address the unmet medical needs of FOP patients and plans further global regulatory submissions.

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.