Finance Watch: $135m In Venture Capital Will Fund Amylyx’s Late-Stage ALS Drug
Kriya, Adlai Nortye Also Closed VC Mega-Rounds
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.
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Vedanta thinks its live biotherapeutic sourced from clonal cell banking could offer strong prevention against C. difficile infections after antibiotics have cleared an initial infection.
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.
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.