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Tag: trial

Novartis RemIND data at EAACI show Rhapsido® potential as first targeted therapy for chronic inducible urticaria (CIndU)

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

HUTCHMED Highlights Sovleplenib ESLIM-02 Phase III Data in Warm Antibody Autoimmune Hemolytic Anemia Presented at EHA 2026 Congress

— Sovleplenib demonstrated rapid and durable hemoglobin response with favorable safety profile —

ChronicleBio Is Coming for Chronic Disease: Pioneering Immunologist Joins Elite Scientific Team to Translate Biological Signal into Targeted Therapeutics

The Emerging Techbio Company Appoints Dr. John Mumm as CSO Alongside Head of Platform Dr. Yambazi Banda to Decode the Molecular Underpinnings of Neuroimmune...

Cognision Publishes Landmark Study Showing Ketamine Produces Opposite Brain Effects in Different Patients — and That Outcome Can Be Predicted Using EEG

LOUISVILLE, Ky., June 11, 2026 /PRNewswire/ -- Cognision, a leader in neurophysiological biomarker research, today announced the publication of a landmark study in Biological...

Let an AI Robot Take a Part-Time Job for You: CamdClaw Opens a New Way to Explore Automated Side Income

CamdClaw, an AI-assisted quantitative trading platform, is introducing a different idea: instead of spending more hours working yourself, users can explore market opportunities with the help of an automated AI trading assistant.
CamdClaw, an AI-assisted quantitative trading platform, is introducing a different idea: instead of spending more hours working yourself, users can explore market opportunities with the help of an automated AI trading assistant.

Novo Nordisk: Wegovy® pill (semaglutide tablets) becomes first daily GLP-1 weight-loss pill approved in the UK

Novo Nordisk's Wegovy® pill has been approved in the UK as an adjunct to a reduced-calorie diet and increased physical activity for adults

Wave Neuroscience Announces FDA Clearance of MeRT® for PTSD

FIRST-EVER FDA-CLEARED PERSONALIZED CLINICAL TREATMENT SYSTEM FOR POST-TRAUMATIC STRESS DISORDER (PTSD) ESTABLISHES A NEW CATEGORY IN PRECISION MENTAL HEALTHCARENEWPORT BEACH, Calif., June 11, 2026...

Oculis to Present Privosegtor at Upcoming Clinical Trials at the Summit 2026

ZUG, Switzerland, June 11, 2026 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced an upcoming presentation at Clinical Trials at the Summit 2026, taking place on June 12-13, 2026, in Las Vegas, Nevada.

Oculis to Present Privosegtor at Upcoming Clinical Trials at the Summit 2026

ZUG, Switzerland, June 11, 2026 – Oculis Holding AG (Nasdaq: OCS; XICE: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology, today announced an upcoming presentation at Clinical Trials at the Summit 2026, taking place on June 12-13, 2026, in Las Vegas, Nevada.

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven...

Patients in the IMAAVY 30 mg/kg treatment groupa achieved statistically significant durable hemoglobin responseb, with mean hemoglobin improvement of at least 1 g/dL as...

Joybuy launches first ‘Summer Black Friday’ for UK shoppers – no need to wait for winter for unbeatable deals

Almost half of UK consumers want a Summer Black Friday Promotion, new Independent research shows*Black Friday offers, but hotter: Joybuy's Summer Black Friday offers...

DC-Side Safety Protection Upgrade: Sungrow SG510HX Completes Extreme Test at 4,200 m

HEFEI, China, June 10, 2026 /PRNewswire/ -- Sungrow recently announced that its SG510HX utility string inverter (SG465HX for the Middle East region, offering equivalent...

GlycoNex Announces Positive Topline Results for Phase III Clinical Trial of Denosumab Biosimilar SPD8

NEW TAIPEI CITY, June 10, 2026 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the Phase III clinical trial...

/C O R R E C T I O N — The Galien Foundation/

In the news release, The Galien Foundation Announces 2026 Prix Galien UK Award Candidates for "Best Biotechnology Product," "Best Digital Health Solution," "Best Medical...

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