Quantum inks agreement to prep filing for Lucid-MS Phase 2 trial

Quantum Biopharma has signed an agreement with a global pharmaceutical contract research organization to continue advancing Lucid-21-302, its experimental therapy for promoting myelin repair with multiple sclerosis (MS). The collaboration will help the company put together an investigational new drug (IND) application for the therapy, which is also…

Tolebrutinib for SPMS granted FDA breakthrough therapy designation

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Sanofi’s BTK inhibitor candidate tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (SPMS). According to Sanofi, tolebrutinib is the first investigational BTK inhibitor with the ability to reach the brain…

FDA grants fast track status to KYV-101 for progressive forms of MS

The U.S. Food and Drug Administration (FDA) has granted fast track status to KYV-101, Kyverna Therapeutics’ cell-based therapy candidate for people with progressive forms of multiple sclerosis (MS) that are treatment-resistant. The FDA designation is intended to accelerate the development of therapies that aim to address unmet medical…

FDA names Elecsys NfL blood test for MS a breakthrough device

A test called Elecsys NfL  — developed by Roche to measure blood levels of the nerve damage biomarker neurofilament light chain (NfL) in people with multiple sclerosis (MS) — has received breakthrough device designation in the U.S. That status, granted by the U.S. Food and Drug Administration (FDA),…