Ionis, Akcea just got handed a one-way ticket to the end of the regulatory line as the FDA rejects volanesorsen
Ionis $IONS and its sister organization at Akcea have just been slammed with an unexpected rejection of volanesorsen, their drug for regulating plasma triglyceride for patients with rare cases of familial chylomicronemia syndrome.
What happened?
Simply put, we don’t know. All Ionis and Akcea $AKCA did was put out a statement repeating some of their earlier talking points in favor of the drug, which managed to pass muster at the expert panel meeting that was called to review it. They didn’t say why the drug was rejected or what they have to do to win regulators over.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.