Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

Roche reports breakthrough phase III results for investigational multiple sclerosis drug

Fenebrutinib targets cells in the immune system known as B cells and microglia

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024

Multiple sclerosis market to generate sales of $29.8 billion by 2030, forecasts GlobalData

Several late-stage pipeline products have the potential to address some of these unmet needs

Biogen and MedRhythms partner for digital therapeutic targeting the treatment of gait deficits in multiple sclerosis

The investigational prescription digital therapeutic uses a combination of sensors, software, and music based on Rhythmic Auditory Stimulation (RAS)

Roche’s 8-year safety data of Ocrevus shows reduced risk in multiple sclerosis patients

New safety data show a consistent benefit-risk profile across all Ocrevus clinical trials

Brenig Therapeutics launches first-in-human trial of novel neurodegenerative therapy

The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026

Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis

The FDA designation follows visual-function results from the Phase 2 ACUITY trial

Quantum BioPharma completes key toxicity studies for Lucid-MS, paving way for Phase 2 MS trial

Lucid-MS represents a potential breakthrough in the treatment of multiple sclerosis