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Ionis Pharmaceuticals (NASDAQ:IONS) traded higher Tuesday after the U.S. FDA accepted to review a marketing application for its anti-lipid therapy olezarsen, targeted at a rare genetic condition known as familial chylomicronemia syndrome (FCA).
Granting priority review for Ionis’ (IONS) New Drug Application (NDA) for olezarsen, the FDA has set December 19, 2024, as the PDUFA date for the NDA aimed at adults with FCA.
The regulator has noted that it does not plan to conduct an advisory committee meeting regarding the NDA.
The FDA’s priority review speeds up the commercialization of drugs by cutting the review period to six months from the ten months for standard review.
In addition to FCS, olezarsen, an RNA-targeted therapy, is also undergoing studies across three Phase 3 trials for severe hypertriglyceridemia. All three have completed enrollments in H1 2024, and their results are expected in H2 2025.