CHMP Recommends Ioni's TRYNGOLZA Approval For Several Hypertriglyceridemia In EU

The FDA approved 13 drugs in September 2026, including Zanvastro (IONS) for Alexander disease, Omcazio (6620.TWO) for various cancers, Etcamah (AZN) for breast cancer, Pixclara (TLX) for glioma diagnosis, and ISEMBLYD (SRRK) for SMA. Key pricing and clinical data were reported.

The EU drug regulator's expert panel endorsed six new medicines and five label expansions in October 2026, benefiting Eli Lilly, Pfizer, and Johnson & Johnson. Lilly's weight loss pill Foundayo and Pfizer's breast cancer therapy Tukysa received positive opinions. Johnson & Johnson's cancer therapy Talvey was recommended for an indication extension. Other companies like Ionis, Regeneron, and Revolution Medicines also received positive opinions for their respective drugs.

Ionis Pharmaceuticals (IONS) reported that the EMA's CHMP recommended approval of TRYNGOLZA for severe hypertriglyceridemia in Europe. If approved, it would be the first RNA-targeted therapy for this condition. The recommendation is based on Phase 3 studies showing significant reductions in triglycerides and acute pancreatitis events. IONS stock was up 3.33% on Thursday and is up 0.61% in pre-market trading.

Ionis Pharmaceuticals (IONS) received a positive opinion from the CHMP for expanding Tryngolza's use to treat severe hypertriglyceridemia in adults, pending EU Commission approval. The company's P/S ratio is 8.25, below its historical median, and it has a GF Score™ of 63/100, indicating mixed fundamentals. Insiders have been net sellers, and guru investors show cautious sentiment.

Ionis Pharmaceuticals received a recommendation for approval to expand the indication of its drug Tryngolza in the EU. The company's stock has seen a 5-day change of +3.33% and a 1st Jan change of +1.89%. BofA recently adjusted its price target to $91 from $93. The company was also featured in the Wells Fargo 21st Annual Healthcare Conference.

Ionis Pharmaceuticals (IONS) announced that the CHMP recommended TRYNGOLZA (olezarsen) for approval in the EU for severe hypertriglyceridemia (sHTG). The decision, based on Phase 3 studies showing significant triglyceride reductions, is expected from the EC in Q4 2026. TRYNGOLZA is already approved in the U.S. for sHTG and other conditions. Ionis and Sobi collaborate on its commercialization outside the U.S.