Busy June at FDA with 11 upcoming PDUFA dates

One of June’s highest-profile decisions is scheduled for the last day of the month, when FDA is expected to rule on expanding the label of an antisense oligonucleotide therapy, currently approved for an ultrarare disease, into a condition affecting millions of U.S. patients.

The decision is on Tryngolza olezarsen from Ionis Pharmaceuticals Inc. (NASDAQ:IONS). The antisense oligo targets APOC3 and is approved for familial chylomicronemia syndrome. Expansion into severe hypertriglyceridemia would take Ionis’ first wholly owned product into a much larger market...