Amylyx Pharma: CHMP Adopts Negative Opinion On Conditional Marketing Authorisation Of AMX0035

(RTTNews) - Amylyx Pharmaceuticals, Inc. (AMLX) announced the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a negative opinion on the application for conditional marketing authorisation of AMX0035, under the trade name ALBRIOZA, for the treatment of adults with amyotrophic lateral sclerosis in the European Union.

Tammy Sarnelli, Global Head, Regulatory Affairs and Clinical Compliance at Amylyx, said: "We disagree with the CHMP's opinion and will request a formal re-examination procedure of the current Marketing Authorisation Application."

The re-examination procedure is an approximately four-month process.

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