Argenx: Sjögren’s Phase 3 stopped for futility, celiac Phase 2 positive
argenx is discontinuing the Phase 3 UNITY study of subcutaneous efgartigimod in Sjögren’s disease after an independent data monitoring committee concluded at an interim analysis that the study could not meet its primary endpoint (clinESSDAI at week 48). No new safety signals were seen. The same morning, FB102, an anti-CD122 antibody, met the primary endpoint of a 126-patient Phase 2 in celiac disease: under an eight-week gluten challenge, it preserved the gut-lining ratio of villus height to crypt depth better than placebo (p=0.0176). argenx plans to take FB102 into Phase 3.
Context Efgartigimod (Vyvgart) is argenx’s only marketed drug, with $1.5bn of product sales in Q2 2026, and UNITY was one of several registrational studies meant to extend it beyond myasthenia gravis and CIDP. Topline data had been expected in H2 2027. FB102 came with the acquisition of Forte Biosciences in August 2026, and this is its first readout under argenx. There is no approved drug for celiac disease; patients rely on a strict gluten-free diet. argenx held $5.2bn in cash and financial assets at 30 June.
Read-across A headwind for Johnson & Johnson’s nipocalimab, which also blocks FcRn and is in a 655-patient Phase 3 in Sjögren’s disease.
Source: argenx release (UNITY) · argenx release (FB102) · argenx H1 2026 results · ClinicalTrials.gov NCT06741969
Switzerland
Newron: FDA keeps US hold on evenamide Phase 3
The FDA’s written feedback leaves the clinical hold in place at US sites of ENIGMA-TRS 2, a Phase 3 of evenamide as add-on therapy in treatment-resistant schizophrenia. The FDA’s concern is driven by evenamide’s drug class: some sodium-channel blockers are known to cause arrhythmias. Through that lens, the FDA calls the deaths seen on evenamide a potential safety signal for a fatal arrhythmic mechanism. However across all studies, mortality rate come close to placebo, with a 0.56% mortality rate (4 patients) versus one on placebo (0.27%). Moreover, three of the four deaths were judged unrelated to the drug, and one was judged possibly related only because two autopsies found no definitive cause. Adjusted for time on treatment, mortality was lower on evenamide: 1.31 deaths per 100 patient-years versus 1.81 on placebo. Newron says it has seen no pattern of cardiac abnormalities in more than 10,000 ECGs.
Context The FDA cleared the US part of the study in December 2025. It imposed the hold in April, after Newron reported a sudden unexplained death of a participant at a non-US site. The investigator judged that death unrelated, and the safety monitoring board recommended continuing. Today’s letter is the first time the FDA’s reasoning has been set out, and Newron plans to respond after reviewing it. Surprisingly, this is the second time the FDA has asked for more safety work on evenamide. One of them was Study 008, a four-week placebo-controlled study in 138 patients. In 2021 it showed no seizures or cardiac events on evenamide, ECG results in line with placebo, and no discontinuations due to side effects. ENIGMA-TRS 1, a pivotal study of 600+ patients run outside the US, is unaffected, with 12-week topline data due in Q1 2027. Newron had €32.9m in cash at 30 June plus about €11m received in September, which it says funds operations through most of 2027.
Source: Newron release · Newron (hold, April 2026) · Newron (Study 008, 2021) · Newron H1 2026 results
Rest of Europe
Zealand Pharma: petrelintide succeeds in obesity with type 2 diabetes
In the 220-patient Phase 2 ZUPREME-2 trial, once-weekly petrelintide cut body weight by up to 9.2% at 28 weeks, against 2.0% on placebo, and lowered HbA1c by up to 0.65%. Discontinuations due to gastrointestinal side effects were 1.9%, against 1.7% on placebo.
Context Petrelintide, an amylin analog, is Zealand’s lead obesity asset, partnered with Roche for $1.65bn upfront. The first Phase 2, ZUPREME-1 in people without diabetes, showed up to 10.7% weight loss at 42 weeks. Zealand and Roche have started dosing in a Phase 3 programme of about 7,000 participants and plan a Phase 2 combining petrelintide with Roche’s GLP-1/GIP agonist enicepatide in H2 2026.
Read-across Supportive for Gubra (GUBRA), whose AbbVie-partnered amylin analog ABBV-295 entered Phase 2 in August.
Source: Zealand Pharma release · Fierce Biotech (ZUPREME-1, Roche deal) · Gubra release
Bavarian Nordic: 2026 guidance raised on rabies vaccine demand
Bavarian Nordic raised its 2026 revenue guidance to about DKK 6.1bn, from about DKK 5.7bn, and its EBITDA margin to about 32%, from about 30%. All of the increase comes from Travel Health, now expected at about DKK 3.4bn, driven mainly by higher US rabies vaccine sales.
Context This is the third upgrade this year, from an initial DKK 5.0–5.2bn. The August upgrade came from Public Preparedness (government orders), where about DKK 2.4bn of the expected DKK 2.5bn is already secured. Travel Health is now the larger of the two businesses. The company links demand to more animal rabies activity in the US, which has increased vaccination before and after exposure.
Valneva: UK revokes IXCHIQ licence
The UK regulator, the MHRA, has revoked the marketing authorisation of Valneva’s chikungunya vaccine IXCHIQ after a further benefit-risk review for travellers. The decision rests on earlier safety data, not a new signal. Valneva disagrees but will not appeal.
Context The commercial effect is small: IXCHIQ launched in the UK in mid-2025, but sales were low and Valneva had already stopped distributing it there, so no product is on the market. It is the second major market loss after the FDA suspended the US licence in August 2025. The EMA and Health Canada recently completed their own safety reviews and kept the vaccine authorised. About 187,000 doses have been given worldwide, and Valneva is focusing on endemic regions such as Brazil.
Read-across Supportive for Bavarian Nordic (BAVA), whose virus-like-particle chikungunya vaccine Vimkunya has been approved in the UK since 2025.
Source: Valneva release · Valneva (FDA suspension, 2025) · The Pharma Letter (Vimkunya UK approval)