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Biotech Daily Dose

Novartis' Rhapsido Shows Promise In Chronic Inducible Urticaria

By TajSabreen Ahamed   ✉  | Published:  | Google News Follow Us  | Join Us

Novartis (NVS) unveiled late-breaking Phase 3 RemIND trial data at the EAACI Congress, highlighting the potential of Rhapsido (remibrutinib) as the first targeted therapy for chronic inducible urticaria (CIndU).

The study met its primary endpoints across the three most common CIndU subtypes—symptomatic dermographism, cold urticaria, and cholinergic urticaria—with responses seen as early as week 2 and sustained improvements by week 12.

Chronic inducible urticaria (CIndU) affects an estimated 29 million people worldwide, with everyday triggers such as pressure, heat, or cold leading to itchy wheals. Current antihistamine treatments often provide incomplete relief, and no targeted therapies are approved today.

Rhapsido, a selective oral BTK inhibitor, works by blocking histamine release, a key driver of hives and swelling. In the RemIND trial, complete response rates at week 12 were 29.3% for symptomatic dermographism, 56.3% for cold urticaria, and 29.3% for cholinergic urticaria compared with 14-16% for placebo.

Novartis has submitted a supplemental NDA to the FDA for the symptomatic dermographism subtype and plans additional filings globally in 2026. Rhapsido is already approved for chronic spontaneous urticaria (CSU) in multiple regions, and the new data reinforce its potential to expand into CIndU, addressing a significant unmet need.

NVO has traded between $35.12 and $81.44 over the past year. The stock closed Thursday's trading at $43.96, up 2.69%. In pre-market the stock is at $43.58, down 0.89%.

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