On January 16, 2026, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational therapy ianalumab (VAY736) for the treatment of Sjögren’s disease, the second most prevalent rheumatic autoimmune disease affecting approximately 0.25% of the population. Sjögren’s is a chronic, progressive, systemic condition characterized by mucosal dryness, fatigue, joint pain, and increased risk of lymphoma, often leading to significant quality-of-life impairment and frequently remaining undiagnosed or misdiagnosed. Currently, no approved targeted therapies exist, leaving patients with limited symptomatic management options.
On January 8, 2026, AskBio Inc., a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009. This investigational adeno-associated virus (AAV) gene therapy is designed for the treatment of late-onset Pompe disease (LOPD), a rare, progressive genetic metabolic disorder caused by deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or absent GAA levels lead to glycogen accumulation in muscles and tissues, resulting in progressive skeletal muscle weakness, respiratory insufficiency, and significant morbidity; without early intervention, the disease can lead to premature death.
The TOGETHER-PsA trial (NCT06588296) is a 52-week, randomized, multicenter, assessor-blinded, open-label Phase 3b study evaluating the efficacy and safety of concomitant subcutaneous ixekizumab (Taltz, an IL-17A inhibitor) and tirzepatide (Zepbound, a dual GIP/GLP-1 receptor agonist) compared to ixekizumab monotherapy in 271 adults with active psoriatic arthritis (PsA) and obesity (BMI ≥30 kg/m²) or overweight (BMI 27-29.9 kg/m² with ≥1 weight-related comorbidity). Participants had high baseline disease burden (mean DAPSA score 58.65, HAQ-DI 1.3) and mean BMI 37.6 kg/m²; over 60% had prior advanced therapy exposure. Both arms included lifestyle counseling for reduced-calorie diet and physical activity.
In a randomized crossover clinical trial (NCT05263232), Harmsen et al. investigated the metabolic effects of natural daylight exposure during office hours in individuals with type 2 diabetes (T2D). Thirteen participants with T2D, virologically suppressed on treatment, were exposed to either natural daylight (facilitated through windows) or constant artificial office lighting for 4.5 consecutive days in a controlled setting, with interventions separated by a washout period.
GSK announced on January 7, 2026, positive topline results from the two pivotal Phase III trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820), evaluating bepirovirsen, an investigational triple-action antisense oligonucleotide (ASO), as a potential first-in-class finite treatment for chronic hepatitis B (CHB).
