Tag: approval

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New York City, June 12, 2026 (GLOBE NEWSWIRE) --

In 2026 Morvulikent has officially announced the launch of its new AI-powered trading platform, introducing a next-generation automated trading environment designed to simplify financial market participation through artificial intelligence, real-time data analysis, and intelligent automation.

Shell announces pause in share buyback programme

Concept examines how compact, expandable structures could support scalable lunar and planetary settlement while reducing launch volume requirements

Responder rate of 57% at one year in open-label extension (OLE) comparable to 63% at 12 weeks in Phase 2 Avail™ trial

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

CALGARY, Alberta, June 11, 2026 (GLOBE NEWSWIRE) -- Veteran Capital Corp. ("Veteran") (TSXV: VCC.P), a Capital Pool Company listed on the TSX Venture Exchange (the "Exchange"), announces that it has terminated its letter of intent with Powerhive, Inc. ("Powerhive") for its proposed Qualifying Transaction as a result of Powerhive’s failure to complete its required financing and/or enter into a binding definitive agreement within the timeframes set out in the letter of intent, despite repeated extensions.