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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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.
Lilly said it will seek accelerated approval in the US based on Phase II data for its amyloid-clearing antibody, potentially narrowing Biogen/Eisai’s newly approved therapy Aduhelm’s time on the market as the only disease-modifying Alzheimer’s drug.
Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.