Amylyx Pharmaceuticals, Inc.
http://amylyx.com
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Latest From Amylyx Pharmaceuticals, Inc.
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.
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.
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.
Stock Watch: Acadia And Amylyx Trial Failures Were No Shock
The overused phrase ‘pipeline in a product’ translates to ‘disappointment in a product’ when the number of indications in the pipeline contracts towards zero.
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