Ionis And Akcea Obtain Positive Recommendation From Panel, Can They Go All The Way? [Seeking Alpha]
AKCEA THERAPEUTICS (AKCA)
Last akcea therapeutics earnings: 2/25 04:05 pm
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Source: Seeking Alpha
Ionis And Akcea Obtain Positive Recommendation From Panel, Can They Go All The Way?SummaryIonis and Akcea obtain a favorable outcome from an advisory panel with a vote of 12 "for" and 8 "against" approval of volanesorsen.The FDA will likely approve volanesorsen on the premise that a REMS is implemented in order to cover itself on the thrombocytopenia issue.Lately a host of biotechs have had their applications rejected only to be accepted several weeks later due to the FDA being more lenient on the drug approval process.Ionis stands to gain big on FDA approval for volanesorsen because it stands to obtain milestone payments from Akcea, and it owns 68% of Akcea Therapeutics as well.Ionis also has its licensing deal set with Akcea for inotersen which is going up for U.S. regulatory review either late this year or early next year to treat patients with hereditary transthyretin amyloidosis ((hATTR)).
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