The U.S. Food and Drug Administration (FDA) has cleared a Phase 3b clinical trial to test Brainstorm Cell Therapeutics’ cell-based therapy NurOwn (debamestrocel) in people with amyotrophic lateral sclerosis (ALS). The trial, ENDURANCE (NCT06973629), is expected to open soon at more than a dozen sites across…
MaaT033, an oral therapy aiming to restore balance to the collection of bacteria and other microbes in the gut, was safe and well tolerated after three months and showed signs of slowing amyotrophic lateral sclerosis (ALS) progression, according to new data from a pilot Phase 1b trial. The…
Three researchers at Massachusetts General Hospital (MGH) have received 2025 MGH ALS Young Investigator Awards for their research on genetic abnormalities, faulty energy systems, and why some nerve cells are more susceptible to damage than others in amyotrophic lateral sclerosis (ALS). The awards announced by the Sean M.
The real-world use of Radicava (edaravone), an infusion treatment approved for amyotrophic lateral sclerosis (ALS), may cause serious side effects — such as liver problems, blood clots, pain, brain bleeding, and infection — not previously listed in its label, according to data from the U.S. drug regulatory agency’s…
ALS groups are asking lawmakers to preserve federal funding for the National ALS Registry and National ALS Biorepository, the first and only comprehensive nationwide resource to collect and analyze data for better understanding amyotrophic lateral sclerosis (ALS). “A recently leaked draft memo from the U.S. Department of Health and…
A neurosurgeon and his team from the University of California (UC) Davis Health have won The Herbert Pardes Clinical Research Excellence Award — given by the nonprofit Clinical Research Forum — for their work on a brain-computer interface that translates brain signals into speech with greater than 95% accuracy.
RNS60 was well tolerated when inhaled twice daily at home as part of an expanded access program (EAP), and it could be a safe option for people with advanced amyotrophic lateral sclerosis (ALS), a study suggested. “This EAP supports the safety and tolerability of RNS60,” researchers wrote in “…
Neurosense Therapeutics’ oral therapy PrimeC significantly reduces blood levels of miRNAs — molecules involved in regulating gene activity — associated with disease progression and survival in people with amyotrophic lateral sclerosis (ALS). That’s according to six-month biomarker data from the Phase 2b PARADIGM clinical trial (NCT05357950), in which…
Nine patients with an ultra-rare form of amyotrophic lateral sclerosis (ALS) caused by mutations in the CHCHD10 gene were treated with an experimental antisense oligonucleotide (ASO) that’s designed to silence the disease-causing mutations. The treatment was developed as part of Silence ALS, an initiative that designs ASOs, that is,…
Health Canada has invited Neurosense Therapeutics to discuss the potential for giving conditional approval to PrimeC in treating amyotrophic lateral sclerosis (ALS), according to a company filing with the U.S. Securities and Exchange Commission. The upcoming meeting provides an opportunity to consider if the drug is eligible…
