New Phase III success lifts expectations for Novartis Rhapsido in chronic hives

Edited by ad hoc news Flagship & Bestseller Desk. Reviewed before publication on 06/15/2026 at 3:45 PM ET. Details in the imprint.

With fresh Phase III data in hand, Novartis is positioning its oral Bruton’s tyrosine kinase (BTK) inhibitor Rhapsido (remibrutinib) as a flagship immunology therapy that could extend well beyond its current use in chronic spontaneous urticaria. The company reported that the RemIND trial in chronic inducible urticaria met its primary endpoint, showing that twice as many patients achieved meaningful symptom control on Rhapsido compared with placebo while maintaining a favorable safety profile, including no liver safety signal so far according to Zacks' summary of the Phase III results. That efficacy boost, if confirmed by regulators, could strengthen Rhapsido’s role in a niche where many patients remain symptomatic despite modern antihistamines.

What the new Rhapsido data show – and why it matters for patients

The RemIND study focused on chronic inducible urticaria (CIndU), a cluster of rare but debilitating skin conditions in which physical triggers such as pressure, cold, or heat provoke hives and intense itching. Novartis has disclosed that in the symptomatic dermographism subtype, complete response rates at week 12 reached about 29.3% for Rhapsido versus 14.0% for placebo, with similarly pronounced gaps in cold urticaria (56.3% versus 14.6%) and cholinergic urticaria (29.3% versus 15.8%) in the trial population, suggesting a consistent treatment effect across subtypes for patients who had already failed second-generation H1-antihistamines as outlined in Novartis’ clinical trial communications. Clinically, those percentages translate into more patients becoming entirely free of hives and itch, a key outcome given the day-to-day impact of CIndU on sleep, work productivity, and mental health.

Rhapsido is already approved in the United States, European Union, China and several other markets for adults with chronic spontaneous urticaria whose symptoms remain inadequately controlled by antihistamines, and Novartis has now submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration to add symptomatic dermographism, the most common CIndU subtype, as a labeled indication according to coverage by FiercePharma on the company’s expansion plans. If regulators agree with the trial data, Rhapsido would become one of the few targeted oral options specifically approved for chronic inducible urticaria, complementing existing injectable biologics and potentially appealing to both allergists and dermatologists who favor pill-based regimens for long-term disease control.

Beyond efficacy, Novartis highlights that Rhapsido’s safety profile in RemIND remained in line with previous studies, with no emerging liver toxicity, an area of particular scrutiny for BTK inhibitors as a class. The company is positioning the drug as a once-daily oral therapy designed to fit into routine care without the infusion-center logistics required for some biologic treatments, which could support adherence in younger, working-age patients who often struggle with the unpredictability of inducible hives. Strategically, the new data reinforce Novartis’ broader bet on specialty immunology: urticaria therapies are a relatively small slice of global pharmaceutical sales today, but high unmet need and chronic treatment durations make it an attractive flagship niche for the Swiss group’s post-divestment portfolio.

Within Novartis, Rhapsido sits in a growing stable of targeted therapies and biologics intended to offset patent expiries in cardiovascular and oncology franchises, and management has repeatedly pointed to immunology as a pillar of mid-term revenue growth on recent earnings calls. Shares of Novartis (ISIN CH0012005267) last traded on SIX Swiss Exchange in Zurich at CHF 99.20 on 06/14/2026, underscoring how much investors already price in the company’s late-stage pipeline as data like the latest Rhapsido readout come through.

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