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 Formal Intention to Remove RELYVRIO®/ALBRIOZA™ from the Market; Provides Updates on Access to Therapy, Pipeline, Corporate Restructuring, and Strategy
Launch of OLPRUVA® underway Topline results from KP1077 phase 2 study demonstrate clinically meaningful benefits for key IH symptoms Q4 2023 net revenue of $13.2M, and FY 2023 net revenue of $27.5M ...
Amylyx Pharmaceuticals Announces Topline Results From Global Phase 3 PHOENIX Trial of AMX0035 in ALS
PRINCETON, NJ, Jan. 23, 2024 /PRNewswire/ - Medunik USA, member of Duchesnay Pharmaceutical Group (DPG) one of the few anchor companies selected by the Government of Canada for its Global Hypergrowth Project, is pleased to announce that Pheburane® coverage has reached another important milestone to the benefit of Americans with certain urea cycle disorders (UCDs) and is now on the Medicaid Preferred Drug List in 10 states with the recent addition of Georgia, Indiana, Tennessee, and Missouri along with those already in effect in New Hampshire, New Mexico*, North Dakota, Oklahoma, Texas, and Utah*. Pheburane® is also included on the California Contract Drugs List with no prior authorization required and is covered by commercial insurance plans, which now reaches ~80% of the commercially insured US population.
RELYVRIO® and AMX0114 Data to be Presented at 34th International Symposium on ALS/MND
PRINCETON, N.J., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Medunik USA (member of Duchesnay Pharmaceutical Group, an international company selected in the Government of Canada's first Global Hypergrowth...
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.
RELYVRIO® and AMX0114 Data to be Presented at 22nd Annual Northeast ALS Consortium (NEALS) Meeting