Bristol Myers Squibb announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis. These data and five additional abstracts from company-sponsored studies will be presented at the 37thCongress of the European Committee for Treatment and Research in Multiple Sclerosis, taking place virtually October 13-15, 2021. In the DAYBREAK extension study, safety was consistent with prior findings and no new safety signals emerged during the reporting period with long-term use of Zeposia. Treatment with Zeposia demonstrated a low annualized relapse rate of 0.103. At months 36 and 48, 75% and 71% of participants were relapse-free and 3- and 6-month confirmed disability progression was observed in 13.9% and 11.4% of participants in the trial, respectively. In the DAYBREAK trial, of 2,494 participants exposed to Zeposia for an average of 46.8 months, 2,143 participants (85.9%) had any treatment-emergent adverse event, 298 (11.9%) had a serious TEAE and 75 (3.0%) discontinued the study due to a TEAE. The most common TEAEs were nasopharyngitis (19.6%), headache (15.8%), upper respiratory tract infection (11.1%) and lymphopenia (10.3%). Data from this long-term observational study of patients treated for up to 62.7 months are consistent with the established safety profile of Zeposia and with sustained control of disease activity and disability progression. At the ECTRIMS 2021 Congress, Bristol Myers Squibb and collaborators will present multiple abstracts that reinforce the company’s growing body of research in MS and commitment to people living with the disease. Accepted abstracts are available on the ECTRIMS 2021 Congress website. DAYBREAK is a Phase 3, multi-center, long-term open-label extension, randomized, double-blind, double-dummy, active-controlled, parallel group study to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with relapsing forms of multiple sclerosis. Eligible patients from the RADIANCE, SUNBEAM and RPC01-1001 trials diagnosed with relapsing forms of MS are enrolled to receive treatment until the end of the DAYBREAK trial or until the development program is discontinued. Patients in the trial are receiving Zeposia 0.92 mg. In total, 2,639 participants completed the parent clinical trials, and this interim analysis (data cutoff February 2021), includes a total of 2,494 participants with mean (range) Zeposia exposure of 46.8 (0.03–62.7) months in the OLE. The primary objective of the trial is to evaluate safety in the overall population. Bristol Myers Squibb thanks the patients and investigators who are participating in this clinical trial. Multiple sclerosis (MS) is a disabling, unpredictable disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate—a process that's currently irreversible. MS affects 700,000 people in Europe and approximately 2.5 million people worldwide. Relapsing forms of MS, including clinically isolated syndrome, relapsing remitting disease and active secondary progressive disease, is characterized by clearly defined attacks of worsening neurologic function. These attacks—often called relapses, flare-ups or exacerbations—are followed by partial or complete recovery periods. During these recovery periods, also called remissions, symptoms improve partially or completely with no apparent progression of disease. Since MS relapses are unpredictable, patients can feel frustrated, stressed, or scared when they occur.Relapsing forms of MS are the most common disease course at the time of diagnosis. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10-15% with progressive forms of the disease.