Tag Archive for: Lou Gehrig’s disease

The companies announced they will terminate the development of their experimental treatment for amyotrophic lateral sclerosis (ALS) after failing to show improvement in patients in an early-to-mid stage study.

Topline data from the Phase III PHOENIX trial of Relyvrio, which won approval in 2022, showed no significant difference on either the primary or secondary endpoints, according to Amylyx.

The past two years have seen a pair of new treatments approved for a particularly intractable neurodegenerative disease —amyotrophic lateral sclerosis. But while Amylyx’s Relyvrio and Biogen’s Qalsody have crossed the FDA finish line, others have stumbled in a regulatory space that experts say is still evolving.

The Japanese multinational pharma is pledging up to $580 million in a development and commercialization deal with AcuraStem for the latter’s PIKFYVE program for amyotrophic lateral sclerosis.

In its briefing documents, the agency said it does not believe there is sufficient evidence to support NurOwn’s clinical benefit, adding there were large amounts of missing data.

The biopharma world – and markets – spent Thursday evening reacting as the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s AMX0035. 

Longer-term use and early initiation of Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) was effective in slowing disease progression, according to a new analysis by the company published on Wednesday.

Canada has approved Amylyx Pharmaceuticals’ treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, the first such approval for the oral drug. The decision came with certain conditions, including the release of data from its global late-stage study of about 600 patients, which is expected in 2024, as well as additional studies.