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Category: Amylyx

  • Patients dismayed as FDA advisors narrowly reject Amylyx’ ALS drug

    By a narrow margin, an FDA advisory committee has voted against approval of Amylyx’ experimental medicine for amyotrophic lateral sclerosis until the company can provide more evidence that it is effective. The prospects of a positive vote on AMX0035 (sodium phenylbutyrate and taurursodiol) were looking dim after the FDA expressed its doubts about the efficacy […]

  • Amylyx slumps on non-committal FDA reviewer assessment of ALS drug

    Shares in Amylyx Pharma slid today after the FDA published a less-than-enthusiastic assessment of its amyotrophic lateral sclerosis (ALS) therapy ahead of an advisory committee meeting on Wednesday. The document indicates that while data from Amylyx’ CENTAUR trial of AMX0035 is “encouraging”, the FDA reviewer believes a another randomised, placebo-controlled study “would likely be necessary […]

  • PharmaShots Weekly Snapshots (November 01 – 03, 2021)

    Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing Facility, Lexington, Massachusetts, US Amylyx Submits NDA to the US FDA for AMX0035 to Treat Amyotrophic Lateral Sclerosis Published: Nov 3, 2021 | Tags: Amylyx, NDA, US, FDA, AMX0035, ALS […]

  • Amylyx Submits NDA to the US FDA for AMX0035 to Treat Amyotrophic Lateral Sclerosis

    Shots: The NDA is based on CENTAUR trial evaluates AMX0035 vs PBO in 137 patients with ALS The results showed that patients receiving AMX0035 had a significant functional decline at the end of the 6mos. as measured by the ALSFRS-R. In an interim survival analysis @3yrs., 44% lower risk of death, median survival duration (25.0mos. […]

  • Amylyx preps filing for its ALS drug after FDA feedback

    Just a few months ago, Amylyx was talking about having to complete another clinical trial before it could file for FDA approval of its drug for neurodegenerative disease amyotrophic lateral sclerosis (ALS). It’s now accelerating those plans, citing favourable discussions with the US regulator. The company revealed today that it will submit its marketing application […]