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Amylyx Pharmaceuticals, Inc.

Latest From Amylyx Pharmaceuticals, Inc.

Real-World Data Or Studies Of Competitor Drugs Can Serve As Confirmatory Evidence For US FDA

Draft guidance describes seven types of confirmatory evidence that can be used with one adequate and well-controlled clinical study to demonstrate substantial evidence of effectiveness, including evidence from expanded access, real-world data, and studies of other drugs in the same class.

Guidance Documents Drug Approval Standards

Impasse At US FDA Could Mean Stealth Abandons Barth Syndrome Treatment

In an interview with the Pink Sheet, Stealth’s CEO says she is not confident the company could design a clinical trial in the rare disease that would meet the FDA’s expectations.

Rare Diseases Drug Review

Amylyx’s Relyvrio/Albrioza Launch Chugs Along As Firm Gives EU Another Go

The company reported 3,800 ALS patients on drug, a figure that came in slightly below some analyst estimates but which suggested discontinuation rates consistent with the pivotal trial.

Sales & Earnings Neurology

Regulators Still To Get To Grips With Neurodegenerative Outcome Measures

Outcomes measures in the neurodegenerative disease space are not yet well understood by regulators, according to Amylyx, which recently received a negative opinion from the EMA for its amyotrophic lateral sclerosis drug, Albrioza.

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