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Amylyx Pharmaceuticals, Inc.

http://amylyx.com

Latest From Amylyx Pharmaceuticals, Inc.

Keeping Track: Parsaclisib, Kymriah Applications Target Non-Hodgkin Lymphomas; AbbVie Gets New Use For Old Ophthalmic

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Amylyx Will Submit ALS Drug For Approval In The Coming Months

After discussions with the US FDA, the company determined it can file AMX0035 based on Phase II/III results and interim Phase III data. Amylyx is sticking with its go-it-alone strategy for global commercialization.

Drug Approval Standards Neurology

AstraZeneca's Ultomiris Disappoints In ALS, Setting Back Rare Disease Ambitions

AstraZeneca is discontinuing a Phase III trial of the long-acting complement inhibitor it gained via its Alexion acquisition in amyotrophic lateral sclerosis because of lack of efficacy in an interim analysis. Interest is now turning to antisense and cell therapy candidates from other companies that are in late-stage development for the condition.

Clinical Trials Rare Diseases

US FDA Doesn’t Need Conditional Approval Pathway, Cavazzoni Tells House Committee

CDER director says agency has many tools to expedite development and does not endorse adding a pathway similar to EU’s conditional approval. Neurodegenerative diseases hearing in Energy & Commerce Committee focuses more on ALS than Aduhelm.

Neurology Politics
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