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Amylyx Will Submit ALS Drug For Approval In The Coming Months

Continues ‘As Fast As Possible’ Approach With AMX0035

Executive Summary

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.

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Amylyx’s ALS Drug Brings Questions On Efficacy Data Robustness To US FDA Panel

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Public Company Edition: Mergers with special purpose acquisition corporations also continue to take companies public, with three new SPAC offerings in late 2021. Also, Xeris raised $30m in a private placement of stock to support its recently approved drug and Sirnaomics went public in Hong Kong.

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