Neurosense to seek PrimeC approval in Canada next year

Neurosense Therapeutics is gearing up to submit an application to Health Canada for approval of PrimeC to treat amyotrophic lateral sclerosis (ALS). The company said it had a “productive discussion” with Health Canada, during which the agency confirmed that Neurosense’s proposed next steps align with its expectations. A…

Living with ALS certainly comes with many frustrations. For me, the one that challenges me most is a symptom I can’t hide: slowness. My body simply needs more time to move, eat, and speak than everyone else around me. In a world obsessed with speed — from 10-second commercials…

An ALS Association grant totaling nearly $1 million will support a clinical trial testing Pasithea Therapeutics‘ PAS-004 in people with amyotrophic lateral sclerosis (ALS). Funding for the Phase 1 trial is provided by the ALS Association’s Hoffman ALS Clinical Trial Awards Program, an initiative designed to support early…

Clene is planning to submit an application to the U.S. Food and Drug Administration (FDA) in early 2026 requesting accelerated approval of its oral therapy CNM-Au8 for treating amyotrophic lateral sclerosis (ALS). The company’s announcement follows new, positive data — from FDA-requested analyses — showing that CNM-Au8…

My husband, Todd, was asked about his health over the Thanksgiving weekend as we caught up with some old friends. He and I explained that his breathing has been declining recently, that ALS has taken most of his lung function, and he now has to eat with his…

A Phase 2 clinical trial to investigate Tiziana Life Sciences’ intranasal foralumab for the treatment of amyotrophic lateral sclerosis (ALS) has been accepted into the Healey ALS MyMatch program at Massachusetts General Hospital. The program, located at the Sean M. Healey & AMG Center for ALS, is a…

The inspiration for this week’s column comes from a reader’s simple question: “How many mini-exercise sessions do you do a day?” My quick reaction was to think I’d already written quite a bit on the topic of exercise and ALS, and I’d just send along a few links.

The U.S. Food and Drug Administration (FDA) has authorized Neurosense Therapeutics to begin a pivotal Phase 3 trial of its experimental oral therapy PrimeC for the treatment of amyotrophic lateral sclerosis (ALS). The authorization follows the FDA’s positive feedback on the design of the PARAGON trial and…