Andrea Lobo, PhD, science writer —

The U.S. Food and Drug Administration (FDA) has given orphan drug designation to CB03, Zhimeng Biopharma’s small molecule treatment candidate for amyotrophic lateral sclerosis (ALS). CB03 is designed to bolster nerve cell health by regulating potassium channels on these cells, reducing the hyperexcitability that is damaging to…

BrainStorm Cell Therapeutics is withdrawing the application requesting U.S. approval of its cell-based therapy NurOwn for the treatment of amyotrophic lateral sclerosis (ALS). The decision comes on the heels of a recent U.S. Food and Drug Administration (FDA) advisory committee meeting, in which experts ruled nearly unanimously…

NeuroSense Therapeutics has received key patents in Europe, Japan, and Israel covering the use of PrimeC, its investigational, fixed-dose combination therapy, in treating neurological diseases such as amyotrophic lateral sclerosis (ALS). These patents are valid through 2038 and join others covering Prime C’s use in the…

Aruna Bio‘s investigational therapy AB126 significantly eased inflammation in the spinal cord and extended survival in a mouse model of amyotrophic lateral sclerosis (ALS), the company announced. The therapy, which is expected to treat several other neurodegenerative and neuroinflammatory disorders, also significantly reduced the levels of neurofilament…

Akava Therapeutics will soon launch a Phase 1 clinical trial to test AKV9, its investigational therapy for amyotrophic lateral sclerosis (ALS), in healthy people. The trial follows the clearance of Akava’s investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). It will be AKV9’s…

People with amyotrophic lateral sclerosis (ALS) who require noninvasive ventilation in later disease stages use significantly higher opioid doses and for more extended periods than do patients who never need mechanical ventilation, according to a new study in Japan. The opioids were started for these individuals mostly to help…

Elevated blood levels of the Cystatin C protein are significantly associated with faster disease progression and shorter survival in people with amyotrophic lateral sclerosis (ALS), according to a study in China. The protein may serve as a biomarker to predict disease outcomes in people with ALS and identify those…

Coya Therapeutics is planning to file a request with the U.S. Food and Drug Administration (FDA) to continue testing its investigational therapy COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS) in a Phase 2 clinical trial. The company is preparing a meeting with the regulatory agency…

A new home-based neurocognitive platform from Cumulus Neurosciences is feasible to use and patient-friendly, and shows potential to identify cognitive problems and to discriminate between people with amyotrophic lateral sclerosis (ALS), those with frontotemporal dementia (FTD), and healthy individuals. That’s according to preliminary data from a first-in-class study,…

An ongoing Phase 1 clinical trial of QurAlis’ experimental therapy QRL-201 in people with amyotrophic lateral sclerosis (ALS) is expected to open in the U.K. by the end of the year. The announcement follows the trial’s clearance by the country’s Medicines and Healthcare Products Regulatory Agency. “We look…