Amylyx Pharmaceuticals, a Phase 3 biotech developing therapies to treat ALS, filed on Thursday with the SEC to raise up to $100 million in an initial public offering.
Amylyx is developing therapies for amyotrophic lateral sclerosis (ALS) and a broad range of neurodegenerative diseases. The company believes its lead candidate, AMX0035, is the first drug candidate to show both a functional and survival benefit in a large-scale clinical trial of patients with ALS. Amylyx recently initiated a 48-week Phase 3 trial of AMX0035 for the treatment of ALS in the US and Europe. It submitted an NDS in Canada in the 2Q21, an NDA to the FDA in the 4Q21, and plans to submit an MAA in Europe in the 1Q22.
The Cambridge, MA-based company was founded in 2014 and booked $1 million in revenue for the 12 months ended September 30, 2021. It plans to list on the Nasdaq under the symbol AMLX. Amylyx Pharmaceuticals filed confidentially on April 26, 2021. Goldman Sachs, SVB Leerink, Evercore ISI, and H.C. Wainwright are the joint bookrunners on the deal. No pricing terms were disclosed.
