At this week’s American Academy of Neurology annual meeting, Amylyx provided additional data from its Phase III amyotrophic lateral sclerosis study showing the full extent of Relyvrio’s failure.
Tag Archive for: Relyvrio
Amylyx Pharmaceuticals on Thursday released interim results from its ongoing Phase II HELIOS trial, showing that its lead asset AMX0035 (sodium phenylbutyrate and taurursodiol) improved pancreatic function and glycemic control in adult patients with the rare, inherited neurodegenerative disease Wolfram syndrome.
The company will withdraw its amyotrophic lateral sclerosis (ALS) drug – its only product in the market – from the U.S. and Canada after the treatment failed in a key late-stage trial.
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.
Amylyx Pharmaceuticals Inc. said on Tuesday that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment, stalling the company’s plans on introducing its first commercial drug in the region.
The past year has seen incremental victories in the neurodegenerative disease space with the approval of Amylyx’s Relyvrio, in ALS and Biogen and Eisai’s Leqembi (lecanemab) in Alzheimer’s disease. Despite these regulatory milestones, there are still hurdles to overcome, with delivery across the blood-brain barrier topping the list.
As we move into 2023, BioSpace takes a pause to reflect on the year gone by and some of the most remarkable news bits, looking at the top five noteworthy FDA drug and biologic therapy approvals in 2022.
The agency’s top five represent an eclectic mix of cancer, cardiovascular and rare disease drugs.
Amylyx is dipping back into the well to raise funds to launch its recently approved ALS drug Relyvrio. The company plans to offer 6 million shares in a public offering to bring in between $167 to $192.2 million.
Say what you will about the $158,000 price tag on Amylyx’s newly minted Relyvrio or the worthiness of the CENTAUR trial, the FDA’s approval of its third-ever ALS drug has ignited the growing momentum in the space.
