Sweden
Sobi: EU committee backs Tryngolza in severe hypertriglyceridaemia
The EU medicines agency’s committee (CHMP) recommended extending Tryngolza (olezarsen), a once-monthly injection already approved in the EU for the rare inherited disorder familial chylomicronaemia syndrome (FCS), to adults with severe hypertriglyceridaemia, defined as fasting triglycerides of at least 10 mmol/L, on top of diet and other lipid-lowering drugs. In the Phase 3 CORE and CORE2 trials (1,063 patients), it cut triglycerides by up to 72% versus placebo at six months and acute pancreatitis events, the main danger of very high triglycerides, by 85% over 12 months in a pooled analysis. A European Commission decision is expected in Q4 2026.
In plain words
What happened. An expert committee of the EU drug regulator recommended that Sobi’s injection Tryngolza be allowed for adults with very high levels of triglycerides, a type of blood fat. The final EU decision is expected by the end of 2026.
Why it matters. Very high triglycerides can cause inflammation of the pancreas, which can be life-threatening. In trials, the drug cut these fats by up to 72% and pancreas attacks by 85%. Until now it was approved in the EU only for a rare inherited form of the disease.
What it means for others. Arrowhead, a US company, has a rival drug given every three months that is still waiting for this wider use.
Context Earlier than the company planned: Sobi says the opinion came ahead of its previously anticipated timeline; the CORE data had been presented at AHA 2025 and published in the NEJM. Tryngolza is an antisense drug, an RNA-targeted medicine, that lowers the liver protein APOC3; Ionis discovered it and sells it in the US, where it is already approved for this wider use, while Sobi holds the rights in the rest of the world except Canada and China. If confirmed, it would be the first RNA-targeted therapy authorised in the EU for these patients. Sobi reports Q3 26 results on 27 October.
Read-across Adds competition for Arrowhead’s (ARWR) plozasiran (Redemplo), an RNAi drug with the same APOC3 target dosed every three months, which met its Phase 3 SHASTA-3 and SHASTA-4 trials in this setting and is approved in the US for FCS; Arrowhead planned a US filing for the wider use by end-2026.
Denmark
Ascendis Pharma: EU committee backs once-weekly Yuviwel for children with achondroplasia
The CHMP recommended EU approval of TransCon CNP (navepegritide, brand Yuviwel) for children with achondroplasia, the most common form of dwarfism, from two years of age while their growth plates are still open. Given once a week, it would compete with the only drug for the condition approved in the EU so far, which needs a daily injection. The filing rests on three randomised placebo-controlled trials, including the pivotal ApproaCH trial in 84 children aged 2–11, where growth was faster than on placebo with a safety profile similar to placebo, plus up to three years of open-label data. Ascendis expects the European Commission decision in Q4 2026 and a first launch, in Germany, in Q1 2027.
In plain words
What happened. An expert committee of the EU drug regulator recommended approving Yuviwel, a weekly injection from the Danish company Ascendis that helps children with achondroplasia grow taller. Achondroplasia is a genetic condition that causes short stature.
Why it matters. The only drug approved in the EU so far must be injected every day. Ascendis plans to start selling Yuviwel in Germany early in 2027 if the EU gives the final go-ahead. It has been sold in the US since spring 2026.
What it means for others. BioMarin, the US maker of the daily drug Voxzogo, would face a weekly rival in Europe.
Context In line with the company’s plan: Ascendis had guided to an EU decision in Q4 2026. The FDA approved Yuviwel in February 2026, and its first US quarter brought €7.6M of sales in Q2 26, against €252.1M for Yorvipath, its hypoparathyroidism drug and main product. Yuviwel is one of three TransCon medicines that Ascendis aims to turn into products with more than $1B of sales each. The EMA will also review whether the drug keeps its orphan status, which normally gives ten years of EU market exclusivity.
Read-across Adds competition in Europe for BioMarin’s (BMRN) Voxzogo (vosoritide), a daily injection approved in the EU since 2021, though its label starts at four months of age, earlier than Yuviwel’s two years.
Zealand Pharma: Kv1.3 blocker ZP9830 well tolerated in multiple-dose Phase 1
Four weeks of under-the-skin dosing with ZP9830 in 32 healthy volunteers caused only mild, non-serious side effects and no dose-limiting safety findings, and its blood levels support longer trials, Zealand said. ZP9830 blocks Kv1.3, a potassium channel that is increased on the memory T cells that drive many autoimmune diseases, so it aims to calm these cells without suppressing the whole immune system. A Phase 1b trial in plaque psoriasis, the first to measure effect on disease, is under way, and a Phase 2 trial in another autoimmune disease is planned for H1 2027.
In plain words
What happened. Zealand, a Danish drug developer, gave its experimental drug ZP9830 to healthy people for four weeks. Side effects were only mild.
Why it matters. This early test was about safety, not about whether the drug works. The first test in patients, people with the skin disease psoriasis, has started. ZP9830 is Zealand’s first step outside obesity and metabolic diseases, its main field, into diseases where the immune system attacks the body.
Context In line with guidance: Zealand had said in August that it expected these results in H2 2026, after positive single-dose data. The release gives no dose levels or blood-level figures. Zealand’s main programme remains petrelintide, an obesity drug partnered with Roche, and Zealand held DKK 14.5B in cash and securities at the end of June 2026.
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