Keyword: Akcea Therapeutics
Akcea CEO Paula Soteropoulos, Chief Business Officer Sarah Boyce and Chief Operating Officer Jeff Goldberg are bidding the company adieu.
The decision sets Novartis up to test the RNA-targeting drug in a phase 3 cardiovascular outcomes trial.
Akcea and Ionis' self-administered Tegsedi is more convenient than Alnylam's Onpattro, but it comes with a boxed warning.
Intellia Therapeutics is developing a CRISPR-based treatment to edit the mutation that causes transthyretin amyloidosis.
Akcea has its first FDA approval for hATTR therapy Tegsedi but will be burdened with a black box warning as it chases rival Alnylam.
Akcea reported topline data showing its hyperlipoproteinemia drug lowered lipoprotein(a) levels in a phase 2 study in patients with cardiovascular disease.
Ex-Gilead CMO Andrew Cheng to lead Akero; Sanofi trades executives with Bayer in restructuring; and Crescendo names ex-Roche leader as CMO.
The cuts come 10 days after the FDA rejected a filing for approval of ultrarare lipid disorder drug volanesorsen.
The FDA rejected Akcea’s volanesorsen three months after the drug squeaked past an FDA advisory committee that voted 12-8 to recommend its approval.
Pfizer’s ATTR drug tafamidis has hit the mark in a phase 3 trial, setting up regulatory filings and a challenge to rivals Alnylam and Ionis/Akcea.