Can Akcea Therapeutics, Inc. and Ionis Pharmaceuticals, Inc. Recover? [The Motley Fool]
AKCEA THERAPEUTICS (AKCA)
Last akcea therapeutics earnings: 2/25 04:05 pm
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Source: The Motley Fool
A surprise rejection is a major setback for both partners, but not the end of the line. Akcea Therapeutics, Inc. ( NASDAQ:AKCA ) and Ionis Pharmaceuticals, Inc. ( NASDAQ:IONS ) recently announced a rejection that caught the market off guard. The companies didn't have much to say, but we can run down some clues that help explain the FDA's surprising decision. What happened? The FDA issued the partners a complete response letter (CRL) regarding an application for a rare-disease drug called Waylivra, and they're being awfully tight-lipped about it. Even though these letters aren't subject to full disclosure, companies are usually quick to point out minor details that need to be addressed before submitting again. Image source: Getty Images. Since Akcea and Ionis haven't offered any details, minor or otherwise, the problem probably won't be an easy fix. If I had to guess, I'd say the partners failed to satisfy safety concerns. During a study underpinnin
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