PipelineRSSMay 13
The FDA has given special fast-track status to COYA 302, an injection treatment being developed by Coya Therapeutics for ALS (a disease that weakens muscles over time). Early testing showed it might slow down how quickly the disease gets worse in a small group of patients. Fast-track status means the FDA will review this treatment more quickly than usual to help get it to patients faster.
WHY IT MATTERSALS patients now have a potential new treatment option moving through FDA review faster than standard timelines, which could mean access to COYA 302 years sooner if clinical trials continue to show benefit.
PipelineRSSMay 7
The FDA has given fast-track status to tazbentetol, a new oral medication being developed by Spinogenix for ALS (a disease that affects nerve cells that control muscles). Fast-track status means the FDA will review this drug more quickly and the company can talk with FDA regulators more often during development. This designation is given to treatments for serious diseases where there aren't many good options available.
WHY IT MATTERSFast-track designation could bring tazbentetol to ALS patients 1-2 years sooner than standard FDA review timelines, which is critical since ALS progresses rapidly and patients have limited treatment options.
PipelineRSSMay 5
A company called Clene is planning to ask the FDA to approve a new drug called CNM-Au8 for treating ALS, a disease that affects nerve cells and causes muscle weakness. The company met with the FDA and decided to use a faster approval process called accelerated approval, which can get promising treatments to patients more quickly than the standard process.
WHY IT MATTERSIf CNM-Au8 receives accelerated approval, ALS patients could gain access to a new treatment option sooner than through the standard FDA review timeline, potentially slowing disease progression.
Clinical trialRSSMay 4
A new experimental drug called dazucorilant helped people with ALS live longer when given at a higher dose, according to a Phase 2 clinical trial. While the trial didn't fully meet all its main goals, the survival benefit was significant enough to be noteworthy. This suggests the drug may have promise for treating ALS, a disease that affects nerve cells controlling muscles.
WHY IT MATTERSIf dazucorilant advances to Phase 3 testing, ALS patients may have access to a new treatment option that could extend survival, which is critical since current ALS therapies have limited effectiveness.
Clinical trialRSSApr 28
Scientists are testing a new drug called RAG-17 for people with a specific type of ALS (a disease that weakens muscles over time) caused by a SOD1 gene mutation. Early results show the drug was safe at different doses and made important disease markers improve. This is early-stage testing, but it's a promising first step.
WHY IT MATTERSIf you have SOD1-ALS, this is one of the first treatments specifically designed for your genetic form of the disease, and early signs suggest it may slow the damage happening in your body.
Clinical trialRSSApr 22
A new drug called masitinib helped ALS patients live longer than expected. In a clinical trial, over 40% of patients treated with masitinib survived for at least 5 years from when their disease started. This is much better than the typical outcome, where fewer than 25% of ALS patients usually live that long.
WHY IT MATTERSIf masitinib gains approval, ALS patients may have access to a treatment that could significantly extend their survival time compared to current standard care.
NewsUNITERAREApr 3
The PAN Foundation's financial assistance fund for ALS (a disease that affects nerve cells controlling muscles) is currently closed and not accepting new applications. This fund previously provided up to $12,000 per year to help patients pay for treatment costs. The fund status changed on April 2, 2026.
WHY IT MATTERSIf you have ALS and were counting on this $12,000 annual assistance from PAN Foundation, you'll need to explore other financial resources immediately, as this fund is no longer available.