Financial Performance - Novartis Q3 2025 net sales reached USD 13909 million, a 7% increase in constant currencies compared to Q3 2024[19, 108] - Core operating income also grew by 7% in constant currencies, reaching USD 5460 million in Q3 2025[19, 108] - The core margin was 393% in Q3 2025[19, 108] - Free cash flow for 9M 2025 was USD 15941 million, a 26% increase compared to 9M 2024[108, 112] - The company reaffirms its 2025 full-year guidance, expecting high single-digit sales growth and low-teens core operating income growth in constant currencies[20, 119, 120] Key Products Growth - Kisqali experienced a 68% growth in constant currencies during Q3[25, 27] - Kesimpta sales increased by 44% in constant currencies in Q3[25, 40, 41] - Pluvicto sales grew by 45% in constant currencies in Q3[25, 47, 48] - Scemblix sales increased by 95% in constant currencies in Q3[25, 67, 68] - Leqvio sales grew +54% cc in Q3[60, 61] Pipeline and Innovation - Rhapsido received FDA approval for Chronic Spontaneous Urticaria (CSU)[22, 88] - Ianalumab showed positive Phase III results in Sjögren's Disease (SjD)[22, 93] - Pluvicto's PSMAddition trial demonstrated a 28% reduction in risk of progression or death in PSMA+ mHSPC patients[54, 59]

Core Viewpoint - The U.S. FDA has approved a label expansion for Telix Pharmaceuticals' Illuccix® to include patient selection for radioligand therapy (RLT) in the pre-taxane setting, which is expected to significantly increase its clinical utilization [1][2]. Group 1: FDA Approval and Market Impact - The label expansion for Illuccix® is its third indication, allowing for the selection of patients indicated for PSMA-directed therapy [2]. - Following the FDA's approval of Pluvicto® for use in metastatic castration-resistant prostate cancer (mCRPC) patients, the clinical utilization of Illuccix® is projected to increase by at least 20,000 scans annually [2]. Group 2: Clinical Significance - The expansion of the indication allows clinicians to make more informed and personalized decisions earlier in the disease course, potentially providing access to life-prolonging targeted radionuclide therapy for more prostate cancer patients [3]. - PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer, enhancing the diagnostic accuracy of Illuccix® [3]. Group 3: Product Information - Illuccix® is used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer [4]. - The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, with the most commonly reported adverse reactions being nausea, diarrhea, and dizziness, occurring at a rate of less than 1% [7][8].