22:06 , May 7, 2019 |  BC Extra  |  Company News

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...
17:36 , Mar 8, 2019 |  BC Week In Review  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions on March 1, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first...
22:10 , Mar 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions Friday, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first approved antidote...
19:28 , Dec 21, 2018 |  BC Week In Review  |  Company News

Novo gets option to cardiovascular company Staten

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) gained an option to acquire Staten Biotechnology B.V. (Nijmegen, the Netherlands), including its lead candidate, STT-5058, in development to reduce cardiovascular risk in patients with hypertriglyceridemia. STT-5058 is an...
23:26 , Dec 17, 2018 |  BC Extra  |  Company News

Novo gets option to cardiovascular company Staten

Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) received an option to acquire Staten Biotechnology B.V. (Nijmegen, the Netherlands) along with its lead candidate, STT-5058, which is in development to reduce cardiovascular risk in patients with hypertriglyceridemia....
21:40 , Sep 25, 2018 |  BC Extra  |  Company News

Management tracks: Curis, Gemphire

Cancer company Curis Inc. (NASDAQ:CRIS) named COO James Dentzer president and CEO and appointed him as a board member. He replaces Ali Fattaey, who is departing. Curis had promoted Dentzer to COO this year. Cardiometabolic...
22:42 , Sep 21, 2018 |  BioCentury  |  Product Development

Arrowhead refills its quiver

Arrowhead Pharmaceuticals Inc.’s tox blowup in 2016 set back its clinical timelines, but it also prompted the company to bring a more versatile platform online faster than originally planned. Early data from replacement candidates suggest...
19:58 , Sep 7, 2018 |  BC Week In Review  |  Company News

Akcea cutting workforce by 10% after Waylivra CRL

Akcea Therapeutics Inc. (NASDAQ:AKCA) will reduce its workforce by about 10% following receipt of a complete response letter from FDA for Waylivra volanesorsen to treat familial chylomicronemia syndrome (FCS). Akcea announced the CRL on Aug....
18:40 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Delay for Akcea's volanesorsen

Akcea Therapeutics Inc. (NASDAQ:AKCA) said it received a complete response letter for Waylivra volanesorsen to treat familial chylomicronemia syndrome (FCS), going against an FDA panel vote in May that backed approval of the compound. The...
18:01 , Aug 28, 2018 |  BC Extra  |  Financial News

Akcea, Ionis tumble on volanesorsen setback

Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) each fell double-digits on Tuesday following a complete response letter from FDA for Waylivra volanesorsen. Akcea slid $8.39 (25%) to $24.73, while Ionis was down $8.53...