News

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…

AMX0114 receives FDA fast track status for the treatment of ALS

The U.S. Food and Drug Administration (FDA) has granted fast track designation to AMX0114, an experimental therapy being developed by Amylyx Pharmaceuticals, for the treatment of amyotrophic lateral sclerosis (ALS). Fast track status is designed to facilitate the development and review of treatments that have the potential to address…

Zydus’ usnoflast wins FDA’s fast track drug status for treating ALS

The U.S. Food and Drug Administration (FDA) has granted fast track status to usnoflast, Zydus Lifesciences’ experimental oral inhibitor, for treating amyotrophic lateral sclerosis (ALS). The designation is meant to accelerate the development and review of new therapies that address unmet medical needs in serious or life-threatening conditions, and…

Brainstorm taps Minaris to produce NurOwn for Phase 3b trial

Brainstorm Cell Therapeutics is partnering with Minaris Advanced Therapies to manufacture NurOwn (debamestrocel), its investigational cell therapy for amyotrophic lateral sclerosis (ALS), for an upcoming Phase 3b clinical trial. The companies signed a letter of intent outlining the collaboration, under which Minaris, a contract development and manufacturing…