China’s Center for Drug Evaluation (CDE) has approved a request by Zhimeng Biopharma to launch a Phase 2/3 study of its experimental therapy CB03-154 in people with amyotrophic lateral sclerosis (ALS). The oral treatment, which is designed to slow disease progression by reducing nerve cell overactivity, is also…
The U.S. Food and Drug Administration (FDA) has granted fast track designation to AMX0114, an experimental therapy being developed by Amylyx Pharmaceuticals, for the treatment of amyotrophic lateral sclerosis (ALS). Fast track status is designed to facilitate the development and review of treatments that have the potential to address…
Brainstorm Cell Therapeutics is partnering with Minaris Advanced Therapies to manufacture NurOwn (debamestrocel), its investigational cell therapy for amyotrophic lateral sclerosis (ALS), for an upcoming Phase 3b clinical trial. The companies signed a letter of intent outlining the collaboration, under which Minaris, a contract development and manufacturing…
ATH-1105, an experimental oral therapy for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, was found to be safe and well tolerated in healthy volunteers, according to the treatment’s developer, Athira Pharma. The data comes from a first-in-human Phase 1 trial (NCT06432647) that tested the safety and pharmacological…
Neurosense Therapeutics said it’s scaled production of PrimeC, its oral therapy for amyotrophic lateral sclerosis (ALS), to commercial levels as it awaits regulatory approval to launch the medication in Canada. “This manufacturing milestone represents a critical leap forward in our commercialization roadmap,” Alon Ben-Noon, CEO of Neurosense, said in…
Alchemab Therapeutics has entered into a licensing agreement with Eli Lilly to develop and market ATLX-1282, a therapy candidate for amyotrophic lateral sclerosis (ALS) and other neurodegenerative conditions. ATLX-1282 was developed using Alchemab’s platform, which uses machine learning and artificial intelligence (AI) to identify potential therapeutic targets for diseases…
Note: This story was updated May 13, 2025, to correct information about the company’s clinical trials. Spinogenix has received clearance from the U.S. Food and Drug Administration (FDA) to launch an expanded access program (EAP) for SPG302, its oral treatment for amyotrophic lateral sclerosis (ALS). EAPs, also known…
Daily treatment with IPL344 for up to three years was safe and appeared to slow amyotrophic lateral sclerosis (ALS) progression, according to recently published data from a small Phase 2a clinical trial. Patients undergoing treatment gained weight and experienced slower declines in functional abilities and lung function. The…
The ALS Association is teaming with the workplace learning company Schoox to provide education resources for patients, caregivers, healthcare providers, and others affected by amyotrophic lateral sclerosis (ALS). With this partnership, Schoox will provide fast and easy access to a range of resources, including educational materials and…
Taking statins to lower cholesterol does not affect survival outcomes for people with amyotrophic lateral sclerosis (ALS), researchers in Norway have found. In a study of ALS patients using national health registry data, the scientists compared the life expectancy of statin users and nonusers. According to the team, “statin use…
