Amylyx stock slips 6% after phase 2 rare disease data drop
Based on topline results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started a process with the FDA and Health Canada of voluntarily discontinuing the marketing authorizations for RELYVRIO/ALBRIOZA
Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS
RELYVRIO® and AMX0114 Data to be Presented at 34th International Symposium on ALS/MND
Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas.
The European Medicines Agency recommended that Amylyx Pharmaceuticals’ ALS drug be rejected within the EU.
Amylyx’s ALS drug Relyvrio brought in $71.4 million in revenue in the first quarter of the year, far surpassing expectations for a CNS therapy approved less than a year ago.
Masako Nakamura will lead Relyvrio’s march to key regions as Amylyx’s general manager and head of the Asia Pacific and Latin America international markets. Nakamura, the SVP, head of Asia at Alnylam from 2018-21, tackled a similar gig as GM, Asia with Aegerion Pharmaceuticals and had a 10-year career at Genzyme. Canada approved Amylyx’s ALS drug, known in that country as Albrioza, in June 2022, while the FDA gave it the go-ahead in September following an unconventional second adcomm
New drug approvals were fewer in number in 2022. Is this a trend that will continue into 2023 or is the drop off just a cyclical anomaly?
After a long road filled with scrutiny and uncertainty, Amylyx’s amyotrophic lateral sclerosis (ALS) drug, known as AMX0035, has finally scored FDA approval.