Cue Biopharma announced on Sunday, September 20, 2026 topline results from a Phase 2 trial in China of CUE-221, a humanized anti-IgE IgG1 monoclonal antibody that the company says also reduces IgE synthesis, in 145 patients with moderate-to-severe chronic spontaneous urticaria. Patients were randomized to one of three CUE-221 doses, placebo, or omalizumab 300 mg every four weeks. At week 12, complete hive resolution (HSS7 of 0) was reached by 54%, 53%, and 43% of patients on the 4, 2, and 1 mg/kg doses, versus 11% on placebo and 41% on omalizumab. There were no treatment-related serious adverse events and no hypersensitivity reactions. Cue, which licensed CUE-221 from Ascendant Health, plans a Phase 2b/3 study in chronic spontaneous urticaria and a Phase 2 study in food allergy.
Pulmovant, a Roivant Sciences (NASDAQ: ROIV) company, announced Tuesday September 8, 2026 that the Phase 2 PHocus study of inhaled mosliciguat (a once-daily first-in-class inhaled soluble guanylate cyclase activator) met its primary endpoint in patients with pulmonary hypertension associated with interstitial lung disease. Placebo-adjusted pulmonary vascular resistance reduction was 56.3% at Week 16 (-51.3% mosliciguat vs +6.6% placebo, p<0.0001) — the largest PVR reduction reported in any randomized controlled pulmonary hypertension trial per Pulmovant. Secondary endpoints: placebo-adjusted six-minute walk distance +35.2 meters (p=0.0027) and NT-proBNP -357.7 pg/mL, a 53.2% reduction from baseline (p=0.0002). At Week 24 (exploratory), 6MWD was +52.7 meters placebo-adjusted and NT-proBNP was -487.1 pg/mL (-75.9%). Mosliciguat was well-tolerated with lower cough incidence (12.1%) than placebo (18.2%). The trial enrolled 135 patients across 87 sites in 20 countries. The Phase 3 PHrontier study is enrolling approximately 375 patients globally in a 1:1 randomized double-blind placebo-controlled design. Marc Humbert (Université Paris-Saclay) presented the data at the ERS Congress in Barcelona; Roivant shares closed up approximately 17% on the day. Mosliciguat activates sGC independently of heme and nitric oxide, differentiating it from sGC stimulators like riociguat.