Clene said it planned to give the U.S. Food and Drug Administration (FDA) new data on CNM-Au8 for the treatment of amyotrophic lateral sclerosis (ALS) ahead of a meeting on a path to accelerated approval of the therapy. The company said it would submit a briefing book…

An advisory committee of the European Medicines Agency (EMA) has recommended against granting conditional marketing authorization to masitinib as an oral add-on treatment for amyotrophic lateral sclerosis (ALS). The negative opinion by the Committee for Medicinal Products for Human Use (CHMP) confirms the committee’s view, announced last…

BrainStorm Cell Therapeutics has reached an alignment with the U.S. Food and Drug Administration (FDA) on the chemistry, manufacturing, and controls aspects — known as CMC — of the company’s upcoming Phase 3b trial of NurOwn (debamestrocel), to be tested in people with amyotrophic lateral sclerosis (ALS). This…

On my first date with my late husband, Jeff, he rhapsodized about his family. He was the middle child of seven, and it was clear from the start that his brothers and sisters were a central part of his life. They’d grown up together in a home in Wyandotte, Michigan,…

I’m cautious about leaving my husband, Todd, alone because ALS has compromised his lung function. Todd can usually tell when mucus starts building up, so if his lungs are doing well, we’re comfortable with me running errands or attending events, as long as I’m not more than 15 minutes…

Athira Pharma has completed enrollment of the first group of healthy volunteers who’ll receive a single dose of ATH-1105, its experimental oral therapy for amyotrophic lateral sclerosis (ALS), in a Phase 1 clinical trial. The Phase 1 trial (NCT 06432647),…

After up to 3.5 years on the experimental oral treatment CNM-Au8, the chances of survival for people with amyotrophic lateral sclerosis (ALS) in the open-label extension of the HEALEY ALS platform trial was nearly 60% higher than for a group of patients given a placebo in previous studies.

Adding Radicava (edaravone) to riluzole prolongs survival of amyotrophic lateral sclerosis (ALS) patients by more than three months relative to riluzole alone, according to analyses of real-world data from the ALS/MND Natural History Study Consortium database. These and other Radicava-related findings were presented by the therapy’s developer…

COYA 302, Coya Therapeutics’ experimental immune-modulating combination therapy, safely slows disease progression and reduces levels of disease biomarkers in people with amyotrophic lateral sclerosis (ALS). That’s according to the now-published results from a small proof-of-concept Phase 1 clinical trial (NCT06307301) that tested the therapy in four ALS…

Amid the busyness of last month’s ALS awareness activities, I almost missed learning about the debut of a special movie that I was quite involved with during its early stages. My friend’s email opened with, “Were your ears ringing last night?” That made me sit up straight. She told…