Amylyx Pharmaceuticals Stock Trading Halted Today
FDA Advisory Committee Meeting to Discuss NDA for AMX0035 for the Treatment of ALS
The
The Advisory Committee meeting is scheduled for
The Prescription Drug User Fee Act (PDUFA) target action date for the AMX0035 NDA is
About
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential approval of AMX0035 for the treatment of ALS; the potential of AMX0035 as a treatment for ALS; and expectations regarding our longer-term strategy. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: regulatory developments and expectations regarding the timing of FDA review of AMX0035 for the treatment of ALS, and the impact that the ongoing COVID-19 pandemic will have on FDA review timelines, as well as those risks and uncertainties set forth in Amylyx’
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