comprehensive -WSS

comprehensive

author：focus 2025-09-30 17:28:32 - browse：71454

Amylyx founders — Justin Klee (left) and Joshua Cohen are the co-founders and co-CEOs of Amylyx Pharmaceuticals. Kayana Szymczak for STAT

Amylyx Pharmaceuticals said Friday that its treatment for ALS, called Relyvrio, failed to provide any benefit for patients in a large clinical trial — a stunning outcome that now has the company considering a voluntary withdrawal of the approved medicine from the market.

“This is really hard for us, and it’s really hard for our team who care so much, but it’s so much harder for people with ALS and their families, and we have to keep that perspective,” said a somber Justin Klee, Amylyx’s co-founder and co-CEO, in an interview with STAT on Thursday evening.

In the Phase 3 study involving 664 people with ALS, Relyvrio failed to outperform a placebo on an ALS functional rating scale that measures the ability to perform daily living tasks, walk, breathe, speak, and swallow. The company did not provide detailed results for the study’s primary goal, but said the calculation for statistical significance was 0.67 — well above the 0.05 threshold for success and an indication that Relyvrio provided no benefit at all.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Supreme Court strikes down use of affirmative action
Next article： VC firm RA Capital starts a new synthetic biology incubator

explore

WSS

Interest rates are at a 22

STAT Summit: Biotech founders on deal

Hospitals, health systems can help patients avoid medical debt

STAT Summit: GSK CEO on pharma giant's new direction

STAT Readout Newsletter: Today's biggest biotech updates

Public health communication lessons from Covid

knowledge

comprehensive

focus

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

STAT Summit: Michael J. Fox on progress in Parkinson's research

Drug repurposing or repositioning? The language matters

FDA warns J&J's Abiomed: We will regulate your software

After affirmative action ruling, medical educators look to 'holistic review'

McConnell had minor fall 2 weeks ago, uses wheelchair periodically to get around: Sources

Hepatitis C has a cure — but many Americans still lack access to it

NIH confirmation hearing shows politicization of research

Walensky prepares to leave CDC — and Congress — behind

Studies point to risks of excluding people with obesity from drug trials

hotspot

Biden announces an advanced cancer research initiative

STAT Summit: How a Chicago ER doctor tackles gun violence

Behind warning on Apellis’s eye drug lies a conflict of interest

Beam Therapeutics to lay off 20% of its staff, re

Trump lawyers meet with special counsel in Jan. 6 case as potential indictment looms

Hospitals, health systems can help patients avoid medical debt

knowledge

hotspot

explore

focus