Andrea Lobo, PhD,  science writer—

A final decision by the U.S. Food and Drug Administration (FDA) on whether or not to approve NurOwn for amyotrophic lateral sclerosis (ALS) is now expected no later than Dec. 8. But before that, on Sept. 27, an FDA advisory committee will meet to review the potential benefits…

Apellis Pharmaceuticals’ investigational therapy pegcetacoplan (APL-2) has failed to improve a combined assessment of function and survival in people with amyotrophic lateral sclerosis (ALS), according to top-line data from the MERIDIAN Phase 2 clinical trial. While the treatment was well tolerated, consistent with its established safety profile,…

A Phase 2b trial of PrimeC for people with amyotrophic lateral sclerosis (ALS) has completed patient enrollment, according to NeuroSense Therapeutics, the therapy’s developer. Called PARADIGM (NCT05357950), the study enrolled 69 adults diagnosed with ALS, ages 18-75, at sites in Israel, Italy, and Canada. The company…

Cellenkos has dosed the first patient in the Phase 1/1b clinical trial that’s evaluating its regulatory T-cell-based therapy CK0803 for the treatment of amyotrophic lateral sclerosis (ALS). The patient will be one of six participants included in the Phase 1 run-in period of the REGALS clinical trial…

A Phase 2b trial that’s testing PrimeC in people with amyotrophic lateral sclerosis (ALS) has reached 80% enrollment and is on track to complete patient recruitment by June, NeuroSense Therapeutics announced in a quarterly update. Called PARADIGM (NCT05357950), the study began enrolling ALS patients in…

A first patient has been dosed in a Phase 1 clinical trial evaluating QRL-201, an experimental antisense oligonucleotide (ASO) molecule in treating amyotrophic lateral sclerosis (ALS), the therapy’s developer, QurAlis, announced. Dubbed ANQUR (NCT05633459), the study is reported to be the first into a potential therapy…

NeuroSense Therapeutics has joined researchers at Massachusetts General Hospital to study the impact of its investigational therapy PrimeC on key amyotrophic lateral sclerosis (ALS) processes. The collaboration will the headed by Ghazaleh Sadri-Vakili, director of the Neuroepigenetics laboratory at the MassGeneral Institute for Neurodegenerative Disease. Using a new…

Amylyx Pharmaceuticals is facing a new hurdle — a second round of questions from a European Medicines Agency (EMA) committee — in its quest to have AMX0035 approved as a treatment for amyotrophic lateral sclerosis (ALS) in Europe. The questions, from the Committee for Medicinal Products for…

AviadoBio has entered into a worldwide exclusive agreement to develop and commercialize Neurgain Technologies’ new technique to deliver gene therapies for diseases that affect the spinal cord. The approach will be used at first to deliver AviadoBio’s investigational gene therapies for amyotrophic lateral sclerosis (ALS). It involves…

Biological samples from amyotrophic lateral sclerosis (ALS) patients who took part in the Phase 3 clinical trial of NurOwn, a cell-based therapy, are being donated by BrainStorm Cell Therapeutics to a repository for use by the research community. The samples include blood and spinal fluid (cerebrospinal fluid or CSF)…