Clene plans CNM-Au8 filing for accelerated approval in ALS

Following a recent meeting with the U.S. Food and Drug Administration (FDA), Clene is planning to submit an application asking the agency to approve its experimental therapy CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS). The company specifically plans to file a new drug application (NDA)…

People with amyotrophic lateral sclerosis (ALS) who received a high dose of the experimental therapy dazucorilant had a significantly higher chance of survival than patients given a lower dose or no treatment. That’s according to new analyses of data from the DAZALS Phase 2 clinical trial (NCT05407324), which…

May is ALS Awareness Month, and in the U.S. and around the world, organizations are educating, sponsoring events, and encouraging the community to join them in taking action, providing financial support, and pushing for better access to care through advocacy for those living with amyotrophic lateral sclerosis. The…

After my husband, Todd, got ALS and I became his caregiver, I turned to reading and writing as a way to cope. Reading helps me make sense of life, or sometimes just step outside of my life for a while. Writing helps me sort through what I’m thinking and…

Vectory Therapeutics has been given a green light to expand its first-in-human clinical trial of VTx-002, its treatment candidate for amyotrophic lateral sclerosis (ALS), to sites in the U.K. and the European Union. The Phase 1/2 PIONEER-ALS study (NCT07287397) is already underway in the U.S., and is…

In France, the average family impacted by amyotrophic lateral sclerosis (ALS) has to pay thousands in out-of-pocket expenses to cover such things as mobility aids and paid caregivers — and because patients and caregivers often need to stop working to manage the disease, these expenses pile up on top…

RAG-17, an experimental treatment Ractigen Therapeutics is developing for people with amyotrophic lateral sclerosis (ALS) who carry a SOD1 mutation (SOD1-ALS), was well tolerated at multiple doses and led to profound changes in disease biomarkers, preliminary trial data showed. The data cover the first part of an ongoing…

Deaths from amyotrophic lateral sclerosis (ALS) have nearly doubled in Finland over the past three decades, with increases in mortality seen especially among older adults, according to a new study. The reasons for this trend aren’t clear, however, and the researchers noted that similar increases have not been reported…

In the early, scary months after my late husband, Jeff, was diagnosed with ALS in the fall of 2018, I started to realize that I had no idea what we were up against. At almost 50 years old, I’d heard of ALS only through the Ice Bucket Challenge and…

The Muscular Dystrophy Association (MDA) will return to New York City on June 4 for its 26th annual Wings Over Wall Street Gala. Hosted at 48 Wall Street Events, the high-profile fundraiser unites the financial community and medical researchers to accelerate the search for a cure for amyotrophic…