May 7 Company Quick Takes: Akcea, Bicycle/DDF, Arbutus, Celgene/Sutro, MDGH, Pfizer, Sanofi/Regeneron
Akcea's Waylivra approved in EU
The European Commission granted conditional approval to Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) as an adjunct to diet in adult patients with familial chylomicronemia syndrome who are at high risk for pancreatitis. Akcea plans to launch Waylivra in Germany this year followed by additional European launches in 2020. Last year, FDA issued a complete response letter to the antisense inhibitor of APOCIII, despite an FDA panel vote in its favor (see "Delay for Akcea's Volanesorsen").
Bicycle, Dementia Discovery Fund partner to develop dementia therapies
Bicyclic peptide company Bicycle Therapeutics Ltd. (Cambridge, U.K.) is making its first venture into neuroscience through a deal with the Dementia Discovery Fund to develop therapies for neurodegenerative diseases. Bicycle will identify Bicycles -- fully synthetic short peptides constrained to form two loops that stabilize their structural geometry -- that modulate the activity of proteins implicated in the progression of dementia. Bicycle and DDF will have the option to jointly launch a new company to develop any compounds identified from the collaboration...