Ad hoc announcement pursuant to Art. 53 LR

Basel, July 25, 2022 – Sandoz, a global leader in generic and biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics.

Basel, June 27, 2022 — Novartis today announced new data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension showing continuous treatment with Kesimpta® (ofatumumab) significantly increased the odds of achieving no evidence of disease activity (NEDA-3) versus switching from teriflunomide1. These data were presented at the…

Basel, June 17, 2022 - Novartis today announced that Nature Medicine published final results from both the two- and three-copy cohorts of the completed Phase 3 SPR1NT trial as separate companion manuscripts, reinforcing the transformational benefit of Zolgensma® (onasemnogene abeparvovec) when used early. These data demonstrate that, whether they…

Basel, April 5, 2022 — Novartis today announced new long-term data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension that demonstrated long-term efficacy and safety of Kesimpta® (ofatumumab), with continued reduced risk of disability worsening, for people living with relapsing multiple sclerosis following up to four…

Basel, January 4, 2022 — Today, Novartis announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its decision upholding the validity of US Patent No. 9,187,405 covering a dosing regimen for Gilenya. In August 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision in the Gilenya patent…

Basel, March 2, 2022 — Today, Novartis announced that new data from the ALITHIOS open-label extension study was published in the peer-reviewed Multiple Sclerosis Journal. The data showed that with up to 3.5 years of treatment with Kesimpta® (ofatumumab), no incidences of opportunistic infections were reported, and observed COVID-19 infections…

Basel, March 8, 2022 — Novartis today announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets.

Basel, March 18, 2022 — Novartis today announced that the peer-reviewed journal Neurology and Therapy1 has published new data on COVID-19 infections in people living with relapsing multiple sclerosis (RMS) treated with Kesimpta® (ofatumumab). This data was compiled from the ongoing, open-label, long-term extension phase 3b ALITHIOS study and from…

Basel, February 16, 2021 — Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for Entresto® (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure1. Benefits are most clearly evident in…

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Basel, October 14, 2021 — Today, Novartis announced data demonstrating the safety of Kesimpta® (ofatumumab) over extended exposure (~3.5 years) in patients with relapsing forms of multiple sclerosis (RMS).1 These data—presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place…