Tag: data security

DENVER, June 24, 2026 (GLOBE NEWSWIRE) -- Recently, SKHTU Exchange formally submitted its license application materials to the Monetary Authority of Singapore (MAS), marking the entry of the platforms compliance deployment in the Asian market into a substantive review phase. It is understood that the relevant application materials have completed preliminary acceptance, and the subsequent process will proceed to the document review and operational assessment stage in accordance with the regulatory procedures.

Regulators, associations and startups gathered in Amsterdam to deliver a unified message to the global Fintech community: the time to join the Italian Fintech ecosystem is now

Basel, June 12, 2026 – Novartis today presented data from the RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress showing that Rhapsido^®  (remibrutinib) met its primary endpoints across the three most common chronic inducible urticaria (CIndU) subtypes, becoming the first-ever treatment to demonstrate efficacy in a global Phase III CIndU clinical trial⁷. In the RemIND trial, higher rates of complete responses were observed at week 12, with responses seen as early as week 2 in two subtypes. These results demonstrate that Rhapsido may provide sustained relief for patients whose disease remains inadequately controlled after treatment with second-generation H1-antihistamines⁷.

“Chronic inducible urticaria (CIndU) is a form of chronic hives in which everyday triggers—such as pressure, heat, cold, or sunlight—can lead to itchy wheals, and there are currently no approved targeted treatment options,” said Prof. Dr. med. Martin Metz, Deputy Director, Institute of Allergology, Charité–Universitätsmedizin Berlin, Germany. “The RemIND results across the three most common CIndU subtypes highlight the potential of Rhapsido as an important new treatment option for patients with significant unmet need.”

The three most prevalent CIndU subtypes are symptomatic dermographism (SD), cold urticaria, and cholinergic urticaria, with SD being the most common⁸. Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Rhapsido for the treatment of SD subtype and will continue additional filings to health authorities globally throughout 2026. Rhapsido is approved for use in the U.S., European Union, China and several other countries for the treatment of chronic spontaneous urticaria (CSU), in adult patients with inadequate response to H1-antihistamines.

“Rhapsido significantly improves symptom control for patients living with the three most common subtypes of chronic inducible urticaria, and it has the potential to become the first approved targeted therapy. This is a major step forward for CIndU patients who have limited options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “The CIndU data presented today are consistent with Rhapsido’s proven efficacy and favorable safety profile in chronic spontaneous urticaria and demonstrate Novartis’ commitment to developing truly meaningful innovation for patients with complex immune-mediated diseases.”

Primary endpoint results at Week 12 in the RemIND trial¹

Outcome reflects strong shareholder support for full Board, Company’s Path to Potential strategy and continued momentum under CEO Hillary Super

Basel, June 8th, 2026 – Novartis will present data from 10 abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, spanning Rhapsido^®  (remibrutinib) clinical trial results and real-world evidence on patient burden and treatment experience. Highlights include two late-breaking oral presentations; the Phase III RemIND trial for Rhapsido in chronic inducible urticaria (CIndU) and extension data from the Phase IIIb REMIXED trial in chronic spontaneous urticaria (CSU).

“The Rhapsido presentations at EAACI 2026 expand our understanding of BTK inhibition across multiple immune-mediated diseases and provide evidence of its potential to make a meaningful impact for patients who continue to face significant burden and limited treatment options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “Novartis will present Rhapsido data from a long-term extension trial in chronic spontaneous urticaria, Phase III data in three types of chronic inducible urticaria, and early Phase II dose-response analysis for food allergy – together providing scientific evidence for its impact across numerous diseases.”

Abstracts accepted by EAACI include: