NLS Biotech News

Sobi’s pozdeutinurad significantly lowered serum uric acid levels in patients with uncontrolled gout, with the effect sustained for a full year, according to new Phase III data from the pivotal REDUCE-2 study. The results will be presented in a late-breaking session at ACR Convergence 2026.

Copenhagen-based Genmab says its bispecific antibody petosemtamab, given with pembrolizumab, met both primary endpoints in the global Phase III LiGeR-HN1 trial in first-line recurrent or metastatic PD-L1-positive head and neck squamous cell carcinoma.

Swedish biotech Vicore Pharma’s Phase 2b ASPIRE trial of buloxibutid in idiopathic pulmonary fibrosis (IPF) has passed a pre-planned futility analysis. The independent Data Monitoring Committee recommended that the trial continue without modification, and topline results remain on track for mid-2027.

The final clinical study report from DexTech Medical’s study of OsteoDex in treatment-resistant multiple myeloma confirms the earlier preliminary results. No serious adverse events were reported, and the disease stabilized in all patients during treatment.

Finnish TILT Biotherapeutics has presented Phase Ib results at ESMO 2026 showing that four of nine evaluable patients with platinum-resistant ovarian cancer responded to its candidate TILT-123 combined with immunotherapy and chemotherapy. Two of the patients achieved complete responses.

Adding Amgen’s Imdelltra (tarlatamab) to AstraZeneca’s Imfinzi (durvalumab) as first-line maintenance treatment reduced the risk of death by 58% compared with Imfinzi alone in extensive-stage small cell lung cancer, according to results from the Phase III DeLLphi-305 trial presented at ESMO 2026.

Danish biotech Saniona has submitted an Investigational New Drug (IND) application to the US FDA for SAN2465 in major depressive disorder. If the FDA clears the application, the company expects to start a Phase 1 trial before the end of 2026.

Hansa Biopharma’s imlifidase (Idefirix) achieved 90% graft failure-free survival one year after transplantation in highly sensitized kidney patients in the European post-authorization PAES study. The results were presented as a late-breaking abstract at ASN Kidney Week 2026 in Denver.

Genmab’s antibody-drug conjugate rinatabart sesutecan (Rina-S) significantly improved both progression-free and overall survival compared with chemotherapy in the Phase 3 RAINFOL-02 trial in women with platinum-resistant ovarian cancer.

Gesynta Pharma has completed enrollment in NOVA, its Phase II trial of the non-hormonal, non-opioid drug candidate vipoglanstat in endometriosis. The trial is fully enrolled more than three months ahead of schedule, and topline data are expected in the second quarter of 2027.