Amylyx Will Submit ALS Drug For Approval In The Coming Months
Continues ‘As Fast As Possible’ Approach With AMX0035
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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Citing numerous concerns about design of the Phase II CENTAUR trial and statistical robustness of the results, agency reviewers question whether a single study provides substantial evidence of efficacy for approval of AMX0035.
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.
Public Company Edition: Genenta, Cingulate, ImmixBio, Bionomics and NeuroSense launched initial public offerings, grossing just $118m between them. But Amylyx, with a recently filed ALS drug, has filed to raise up to $100m. In follow-on offerings, Legend took advantage of ASH goodwill to raise $300m.