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Amylyx Pharmaceuticals, Inc.

http://amylyx.com

Latest From Amylyx Pharmaceuticals, Inc.

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

Finance Watch: $135m In Venture Capital Will Fund Amylyx’s Late-Stage ALS Drug

Private Company Edition: Amylyx will use its new cash to run a Phase III trial and submit applications seeking EU and Canadian approvals of AMX0035, but US filing plans based on prior Phase II/III data are less clear. Also, three VC firms raised new funds targeting biopharma and other investments.

Financing Innovation

BrainStorm's Cell Therapy Disappoints In Phase III ALS Study

Top-line results from BrainStorm’s NurOwn Phase III ALS study show the cell therapy missed the primary efficacy endpoint, but clinically meaningful responses were seen in a pre-specified subgroup which investigators considered potentially a significant step forward in therapy.

Neurology Clinical Trials

Amylyx Drug Slows ALS Progression, Filings Imminent

Amylyx has raised just $75m to date, but that was enough to develop AMX0035 through a Phase II/III trial in which the drug slowed the progression of amyotrophic lateral sclerosis versus placebo.

Business Strategies Neurology
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