European Drug Panel Backs Ionis Triglyceride Drug and Lilly Weight-Loss Pill While Rejecting Omeros Transplant Therapy

The European Medicines Agency's Committee for Medicinal Products for Human Use issued a series of regulatory decisions on Friday, approving several treatments and definitively closing the door on one. Among the positive outcomes, the CHMP recommended approval of Ionis Pharmaceuticals' TRYNGOLZA (olezarsen) as an adjunct to diet, in combination with other lipid-lowering therapies, for adult patients with severe hypertriglyceridemia defined by fasting triglyceride levels of at least 880 mg/dL (10 mmol/L). The drug will be marketed in Europe by Sobi.

Eli Lilly's once-daily oral weight-loss and diabetes pill Foundayo also received a positive CHMP opinion, extending the company's obesity franchise into the European market with a pill formulation. Ascendis Pharma's once-weekly TransCon CNP (navepegritide) won a positive CHMP opinion for the treatment of achondroplasia in children, and Regeneron's Libtayo (cemiplimab) was recommended for an updated dosing regimen across all of its already-approved cancer indications.

Omeros Corporation suffered the sharpest setback of the day. The CHMP upheld its original June 2026 negative opinion on narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy following a re-examination that included an eight-member ad hoc expert group. The rejection was final, and Omeros said its compassionate-use program for the drug would end. Shares of Omeros fell approximately 4.2% in premarket trading, dropping below a key support level not breached in nearly three months.