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Amylyx Pharmaceuticals, Inc.

Latest From Amylyx Pharmaceuticals, Inc.

Relyvrio’s Failure Sparks NeuroSense ALS Development Changes

NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.

Neurology Clinical Trials

Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA

Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.

Post Market Regulation & Studies Advisory Committees

Amylyx’s Relyvrio Withdrawal May Trigger More Public Pledges Based On Confirmatory Trial Data

Company makes good on vow at a September 2022 advisory committee meeting to withdraw the ALS drug if the PHOENIX trial failed. That pledge served as a backstop to FDA’s approval decision based on a single study and created a level of sponsor accountability that often is missing when postmarketing studies fail.

Post Market Regulation & Studies Drug Approval Standards

Amylyx Resets As A Clinical-Stage Company, Withdrawing Relyvrio

The ALS treatment Relyvrio was removed from the market as expected following a Phase III trial failure.

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