Kesimpta® (ofatumumab)

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New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies
Globenewswire· 2025-09-24 06:30
Core Insights - Novartis announced new data on Kesimpta® (ofatumumab) for relapsing multiple sclerosis (RMS) to be presented at ECTRIMS 2025 Annual Meeting [1] - The studies demonstrate significant efficacy and safety of Kesimpta in patients who switched from other therapies [2][3] Study Findings - The ARTIOS Phase IIIb study showed a low annualized relapse rate (ARR) of 0.06 over 96 weeks for patients switching to Kesimpta, with over 90% achieving no evidence of disease activity (NEDA-3) [2][6] - The ALITHIOS study indicated that more than 90% of recently diagnosed treatment-naïve patients achieved NEDA-3 at seven years, highlighting long-term efficacy [3][6] Safety Profile - No new safety concerns were reported in both studies after switching to Kesimpta, reinforcing its favorable safety profile [2][3] Product Overview - Kesimpta is a targeted B-cell therapy administered via subcutaneous injection, approved in over 92 countries, with more than 150,000 patients treated as of August 2025 [5][6] Company Background - Novartis has over 80 years of experience in tackling neurological conditions and continues to develop transformative treatments in multiple sclerosis and other neurological diseases [7]
Genmab(GMAB) - 2025 Q2 - Earnings Call Presentation
2025-08-07 16:00
Financial Performance - Total revenue increased by 19% from USD 1382 million to USD 1640 million[39] - Operating profit increased by 56% from USD 352 million to USD 548 million[39] - Recurring revenue grew by 27%[38] - Combined commercialized medicines sales increased by 60% from USD 181 million to USD 289 million[23] - Cash reserves stand at USD 29 billion[12] Product Performance - EPKINLY net sales increased by 74% to USD 211 million[27] - TIVDAK net sales increased by 30% to USD 78 million[32] - Rina-S® showed a confirmed ORR of 500% in endometrial cancer patients[17] Pipeline Development - EPCORE® FL-1 clinical trial met dual primary endpoints of ORR and PFS, reducing the risk of disease progression or death by 79%[14] - sBLA for EPKINLY® in 2L FL accepted with a PDUFA date of November 30, 2025[13] Guidance - Revenue guidance improved to USD 3500-3700 million, representing a 15% year-over-year growth[41] - Operating profit guidance improved to USD 1055-1405 million, representing a 26% year-over-year growth[41]