News

Clene working with FDA on accelerated approval for CNM-Au8

Clene has incorporated suggestions from the U.S. Food and Drug Administration (FDA) on its analysis plans for certain biomarker data that’s expected to support an accelerated approval application for CNM-Au8 to treat amyotrophic lateral sclerosis (ALS), the company has announced. Specifically, the FDA had suggested revisions to…

An author discusses ALS and how she became an activist

Mindy Uhrlaub, an author and activist for amyotrophic lateral sclerosis (ALS), has spent a good part of her life caring for loved ones. Soon after she became a mom in 2003, her husband learned he had cancer. “Right as my older son was taking his first wobbly steps, my…

Usnoflast well tolerated, shows signs of efficacy in ALS patients

An experimental oral treatment from Zydus Lifesciences was well tolerated at all tested doses and showed signs of slowing disease progression in people with amyotrophic lateral sclerosis (ALS). That’s according to findings from a proof-of-concept Phase 2a trial (NCT05981040) in India that tested Zydus’ usnoflast in 24…

9 of 10 NurOwn-treated ALS patients surpass five-year survival

Nine out of 10 people with amyotrophic lateral sclerosis (ALS) who received the experimental cell therapy NurOwn (debamestrocel) in an expanded access program (EAP) following a placebo-controlled Phase 3 trial survived for at least five years after the onset of their symptoms. That’s according to data announced by…

Dazucorilant significantly extends survival in Phase 2 ALS trial

Dazucorilant, an oral cortisol modulator being developed by Corcept Therapeutics, significantly improved survival among people with amyotrophic lateral sclerosis (ALS) in a Phase 2 clinical trial. Despite it failing to slow disease progression, the trial’s main goal, Corcept is now seeking guidance from U.S. and European regulators to determine…