Chronic spontaneous urticaria (CSU) is a mast cell-mediated skin disorder with recurrent hives and/or angioedema lasting at least 6 weeks without a specific external trigger. It can significantly affect sleep, function, and quality of life.
Novartis beat second-quarter profit expectations as Kisqali, Kesimpta and Leqvio offset a 50% plunge in Entresto sales. The Swiss drugmaker maintained its full-year guidance and awaits late-stage data on three experimental drugs.
Cue Biopharma appointed Dominic Borie as chief medical officer and R&D head as it advances CUE-221 (Phase 2 data expected Q3 2026) and CUE-401 (Phase 1 start Q4 2026). He brings over 20 years of immunology and clinical development experience. The company recently raised $50M to support clinical development.
Two studies examined blood biomarkers for omalizumab response in chronic spontaneous urticaria. Basophil histamine content did not predict response, while higher baseline monocyte counts were linked to complete remission in a 52-patient retrospective analysis.
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
Novartis announced positive topline results from its Phase III RemIND trial of remibrutinib in chronic inducible urticaria, meeting the primary endpoint for the three most prevalent types of the condition with significantly higher complete response rates versus placebo.
Novartis announced positive topline results from its Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint across three prevalent subtypes with significantly higher complete response rates versus placebo at Week 121.
Novartis announced positive Phase III RemIND trial results for oral remibrutinib in chronic inducible urticaria, marking the first therapy to meet a Phase III primary endpoint in the condition. The company has submitted a supplemental New Drug Application to the FDA.
Novartis reported positive Phase III RemIND trial results showing remibrutinib achieved complete response in three types of chronic inducible urticaria. The company has submitted a supplemental New Drug Application to the FDA for symptomatic dermographism.
Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint for three prevalent CIndU types with significantly higher complete response rates versus placebo at Week 12.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07717905 |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU) |
RECRUITING | PHASE1/PHASE2 |
| NCT07686484 |
A Trial of HRS-3095 in Healthy Volunteers |
RECRUITING | EARLY_PHASE1 |
| NCT07642557 |
Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT) |
RECRUITING | |
| NCT07613866 |
A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria |
NOT_YET_RECRUITING | PHASE2 |
| NCT07540910 |
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults |
RECRUITING | PHASE1 |
| NCT07408219 |
A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients |
RECRUITING | |
| NCT07402213 |
Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria. |
RECRUITING | PHASE3 |
| NCT07358780 |
Remibrutinib in Real-world Clinical Practice - a US Sub-study |
RECRUITING | |
| NCT07358364 |
Remibrutinib in Real-world Clinical Practice |
RECRUITING | |
| NCT07316114 |
A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria |
TERMINATED |
