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Inside information: Orion upgrades full-year outlook for 2025
Globenewswire· 2025-07-09 10:00
ORION CORPORATION STOCK EXCHANGE RELEASE – INSIDE INFORMATION 9 JULY 2025 at 13.00 EEST Inside information: Orion upgrades full-year outlook for 2025 Orion Corporation upgrades the full-year outlook for 2025 both for the part regarding net sales and operating profit. Orion’s product sales and royalty income have increased faster than expected during the first half of 2025, and this good development is anticipated to continue during the remainder of the year. Due to these reasons, Orion upgrades the full-ye ...
U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer
Globenewswire· 2025-06-03 20:30
Core Insights - The U.S. FDA has approved darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic castration-sensitive prostate cancer (mCSPC), marking the third indication for this drug [2][9] - The approval is based on the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT [2][10] - Darolutamide is already approved in over 85 markets globally for various indications related to prostate cancer, including mHSPC and non-metastatic castration-resistant prostate cancer (nmCRPC) [5][6] Company Overview - Darolutamide, marketed as Nubeqa®, achieved blockbuster status with annual sales of EUR 1.52 billion reported by Bayer for the full year of 2024 [6] - The drug is developed jointly by Orion and Bayer, indicating a strong collaboration in the oncology sector [6][11] - Orion Corporation has a robust clinical development program for darolutamide, exploring its efficacy across various stages of prostate cancer [13] Industry Context - Prostate cancer is the second most common cancer in men, with an estimated 1.5 million diagnoses and approximately 397,000 deaths worldwide in 2022 [4] - The incidence of prostate cancer is projected to rise to 2.9 million by 2040, highlighting the growing need for effective treatment options [4] - The ARANOTE trial involved 669 patients and assessed the efficacy and safety of darolutamide plus ADT, reinforcing the drug's established safety profile [7][8]