After two meetings with the U.S. Food and Drug Administration (FDA), Coya Therapeutics says it’s received constructive feedback — and has reached an alignment with the agency regarding development plans for COYA 302, its therapy candidate for people with amyotrophic lateral sclerosis (ALS). The company held the two…
Arbor Biotechnologies and 4DMT — two U.S. companies working in next-generation genetic medicines — have established a strategic partnership to develop and commercialize novel gene therapies for neurological diseases, including amyotrophic lateral sclerosis (ALS). The agreement includes the codevelopment of up to six product candidates for diseases…
PharmAust announced that it soon will engage with U.S. Food and Drug Administration (FDA) regulators regarding development plans for monepantel, its investigational therapy for amyotrophic lateral sclerosis (ALS) and motor neuron disease (MND). If the pre-investigational new drug meeting goes well, the company intends to file a…
BrainStorm Cell Therapeutics has received patents in Europe, Australia, and Israel covering the use of investigational NurOwn and NurOwn exosomes in treating amyotrophic lateral sclerosis (ALS) and other neurological disorders. The European patent specifically covers the use of an isolated population of mesenchymal stem cells —…
People with negative responses to a tuberculin skin test a few years after being vaccinated against tuberculosis had a significant, 25% lower risk of developing amyotrophic lateral sclerosis (ALS) in their lifetime, according to a study in Norway. Because a positive reaction is linked to the recruitment of T…
People with amyotrophic lateral sclerosis (ALS) given PrimeC in the PARADIGM Phase 2b trial — and who did not diverge in major ways from the trial’s rules — experienced a significant slowing in disease progression compared with a placebo, the treatment’s developer, NeuroSense Therapeutics, announced. This finding…
Health Canada has cleared ProJenX to open the third part of its ongoing Phase 1 clinical trial and begin testing the experimental therapy prosetin in people with amyotrophic lateral sclerosis (ALS). The first two parts of the PRO-101 trial (NCT05279755) involved healthy participants and showed that the…
A test that assesses the electrical activity associated with blinking may help speed the diagnosis of amyotrophic lateral sclerosis (ALS) and monitor disease progression in people with the condition, a study found. Findings showed that certain electrical waves can significantly distinguish people with ALS from healthy controls or…
A neuroscientist with a specialty in amyotrophic lateral sclerosis (ALS) is joining the faculty at Vanderbilt University Medical Center (VUMC) and will establish an ALS research center at the Nashville school. Véronique Belzil, PhD, whose work is focused on developing tailored treatments for people with ALS, also will serve…
The U.S. Food and Drug Administration (FDA) soon will meet with BrainStorm Cell Therapeutics to discuss the company’s plans for a confirmatory Phase 3b trial of NurOwn in people with amyotrophic lateral sclerosis (ALS). The expedited, face-to-face meeting is scheduled for Dec. 6, less than two months…
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