An experimental, noninvasive device for slowing the progression of functional symptoms in people with amyotrophic lateral sclerosis (ALS) has been awarded breakthrough device designation by the U.S. Food and Drug Administration (FDA). Called MyoRegulator, the neuromodulation device from Pathmaker Neurosystems aims to reduce excessive nerve cell activation,…
NUZ-001, an investigational oral therapy being developed by Neurizon Therapeutics for the treatment of amyotrophic lateral sclerosis (ALS), is officially the ninth compound to be included in the HEALEY ALS platform trial. The announcement follows clearance by the U.S. Food and Drug Administration (FDA) of an amended trial protocol,…
The U.S. Food and Drug Administration (FDA) has cleared the start of a pivotal Phase 3 clinical trial testing the oral therapy pridopidine in people with amyotrophic lateral sclerosis (ALS). Dubbed PREVAiLS, the trial will assess pridopidine’s efficacy and safety in up to 500 people with early, rapidly progressive ALS,…
Qalsody (tofersen) is one step closer to being covered by public Canadian healthcare systems when used to treat adults with amyotrophic lateral sclerosis (ALS) who carry mutations in the SOD1 gene (SOD1-ALS). Developed by Biogen, the therapy was conditionally approved by Health Canada in March, allowing…
Researchers have developed a novel approach to detect amyotrophic lateral sclerosis (ALS) and predict survival outcomes in patients by measuring genetic activity in blood cells, according to a study. The scientists also built on their genetic activity analysis to define biological pathways that are disrupted in ALS and identify…
AMX0114, being developed as an amyotrophic lateral sclerosis (ALS) medication, has been well tolerated in early clinical testing, and a second group of patients will now test a higher dose of the experimental treatment. The first group of 12 participants enrolled in the Phase 1 LUMINA clinical trial…
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…
Actor Eric Dane is teaming up with Target ALS on a campaign to raise $500,000 by Dec. 31 to advance research on amyotrophic lateral sclerosis (ALS). Dane, who was diagnosed with ALS last year, has become a strong advocate for research. He portrayed a character with…
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…
