Today, an overall survival analysis from the CENTAUR trial, which evaluated AMX0035 in people with ALS, was published in Muscle & Nerve. We're thankful to all study participants, their families and the clinicians who contributed to these meaningful results bwnews.pr/3nYGqVa
Amylyx
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- We are thrilled to announce our intention to submit an NDA for AMX0035 for the treatment of #ALS to the U.S. FDA in the coming months. We will share any additional updates with the community as soon as we can.
- Today, we are excited to share news of our plans to submit a New Drug Submission for AMX0035 for the treatment of #ALS with Health Canada in the first half of 2021. This decision is based on the positive clinical data from the CENTAUR trial, and feedback from Health Canada.
- We are excited to share that Health Canada approved our new therapy for the treatment of amyotrophic lateral sclerosis, or #ALS. Read more at the link below. bit.ly/3zBeBue
- We are excited to share that the FDA has accepted for priority review the New Drug Application (NDA) for AMX0035 for the treatment of #ALS.
- We are excited to share that we filed a New Drug Application (NDA) to the FDA for AMX0035 (PB/TURSO) for the treatment of #ALS. This submission represents a major milestone in our efforts to develop a potential new treatment option for the ALS community. bwnews.pr/3GJRBKv
- Today, we are pleased to share that we filed a New Drug Submission (NDS) to Health Canada for AMX0035 (PB-TURSO) for the treatment of #ALS. We look forward to continuing in our efforts to develop a potential new treatment option for ALS. bwnews.pr/3xe5paG
- We are excited to share the full results from our Phase 2/3 CENTAUR trial with the #ALS community in @NEJM. The data are a landmark for those living with the disease and we are looking forward to pursuing next steps for AMX0035. bwnews.pr/32OuM5j
- Today, we announced the launch of an Expanded Access Program (EAP) in the U.S. for our investigational #ALS therapy. Read more here: amylyx.com/media/amylyx-p…
- We at Amylyx, like so many people, are devastated by the loss of @SandyMorris333. Sandy's force of will was unstoppable - she was a lion - and her dedication to the highest principles and ethics while advocating for herself and others was unwavering.
- Today we shared an update on our next steps, including a process we’ve initiated to remove our ALS treatment from the market and provide free access to therapy for those who wish to stay on. These decisions were informed by people who will be impacted and engagement with
- When @pjgreen was diagnosed with #ALS in 2018, he chose to dedicate his life to advocate for those affected by the disease. Along the way, Phil has impacted so many, including his friend Dan White who got tatted in honor of his close friend. #INKEDforALS bit.ly/3ySM6p5
- People with #ALS have no time to wait, which is why we’re investing every possible minute to move ahead and share the detailed results of the CENTAUR clinical trial as soon as we can. It’s our mission to do so efficiently and we will keep you informed on all developments.












