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Novartis' Rhapsido Meets Primary Goal in Phase III Skin Disorder Study
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Key Takeaways
Novartis said phase III RemIND met primary endpoints across three major CIndU subtypes.
Rhapsido delivered higher week 12 complete response rates than placebo, with favorable safety.
NVS has filed for SD approval and plans additional global regulatory submissions in 2026.
Novartis (NVS - Free Report) announced positive results from the RemIND study on Rhapsido (remibrutinib) for chronic inducible urticaria (CIndU), a chronic skin condition, at the European Academy of Allergy and Clinical Immunology (“EAACI”) Congress.
Results showed Rhapsido demonstrated statistically significant and clinically meaningful symptom control in twice as many patients versus placebo, with favorable safety profile and without any observed liver safety concerns.
We note that Rhapsido is under FDA review for CIndU symptomatic dermographism (SD) subtype and additional submissions to global health authorities are expected later in 2026.
Year to date, shares of Novartis have gained 11% compared to the industry’s decline of 4.5%.
Image Source: Zacks Investment Research
Detailed Data From NVS’ RemIND Study
Rhapsido is an oral, highly selective BTK inhibitor designed to block histamine release, a key driver of hives and swelling.
The phase III RemIND study (NCT05976243) is a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety and tolerability of Rhapsido in adults with CIndU that remains inadequately controlled despite treatment with H1-antihistamines.
The study’s primary endpoint is the proportion of patients achieving a complete response at week 12, measured using provocation tests specific to the three major CIndU subtypes. Secondary endpoints include changes from baseline in these measures at weeks 2 and 12, as well as the proportion of patients achieving complete responses at weeks 2 and 24.
The three most prevalent CIndU subtypes are SD, cold urticaria, and cholinergic urticaria.
Rhapsido met its primary endpoints across the three subtypes. The study also marked the first global phase III trial in CIndU to demonstrate efficacy across these subtypes. Higher rates of complete responses were observed at week 12, with symptom improvements seen as early as week 2 in two subtypes.
In the trial, complete response rates at week 12 were 29.3% versus 14.0% with placebo in SD, 56.3% versus 14.6% in cold urticaria, and 29.3% versus 15.8% in cholinergic urticaria. The results suggest that Rhapsido may offer sustained symptom relief for patients whose disease remains inadequately controlled with second-generation H1-antihistamines.
Novartis has submitted a supplemental new drug application (sNDA) to the FDA seeking approval of Rhapsido for the treatment of SD, the most common subtype of CIndU. The company also plans to pursue additional regulatory submissions worldwide throughout 2026.
Please note that Rhapsido is currently approved in the United States, European Union, China and several other markets for adults with chronic spontaneous urticaria whose symptoms remain inadequately controlled with H1-antihistamines.
Novartis is also evaluating the drug in other immune-mediated conditions, including hidradenitis suppurativa and food allergy.
Rhapsido continued to show strong early uptake in the United States and generated sales of $37 million in the first quarter of 2026, supported by a free drug program to facilitate patient access and increasing coverage.
Approval in other indications will bolster NVS’ immunology, which includes Cosentyx, Ilaris and Xolair. Novartis co-promotes Xolair with Roche in the United States and shares a portion of revenues as operating income but does not record any sales in the country.
NVS Looks to Strengthen Pipeline/Portfolio
2026 is a pivotal year for Novartis as it navigates the largest patent expiry in its history.
Novartis is now banking on key growth drivers — Kisqali, Kesimpta, Pluvicto, Scemblix and Leqvio — to support top-line growth.
NVS is also focusing on strategic acquisitions to strengthen its pipeline.
The company is all set to acquire SNV4818 from Synnovation Therapeutics, a pan-mutant selective PI3Kα inhibitor currently in phase I/II for HR+/HER2- breast cancer and other advanced solid tumors. The program aligns with Novartis’ breast cancer strategy and could be combined with CDK inhibitors and endocrine therapies. The deal is expected to be closed in the first half of 2026, subject to customary conditions.
Novartis agreed to acquire Excellergy, including Exl-111, a phase I anti-IgE antibody with extended half-life and high affinity. Its differentiated mechanism may enable faster and deeper receptor downregulation, potentially improving symptom control and dosing convenience in allergic diseases. The transaction is expected to be closed in the second half of 2026, subject to customary conditions.
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Image: Bigstock
Novartis' Rhapsido Meets Primary Goal in Phase III Skin Disorder Study
Key Takeaways
Novartis (NVS - Free Report) announced positive results from the RemIND study on Rhapsido (remibrutinib) for chronic inducible urticaria (CIndU), a chronic skin condition, at the European Academy of Allergy and Clinical Immunology (“EAACI”) Congress.
Results showed Rhapsido demonstrated statistically significant and clinically meaningful symptom control in twice as many patients versus placebo, with favorable safety profile and without any observed liver safety concerns.
We note that Rhapsido is under FDA review for CIndU symptomatic dermographism (SD) subtype and additional submissions to global health authorities are expected later in 2026.
Year to date, shares of Novartis have gained 11% compared to the industry’s decline of 4.5%.
Image Source: Zacks Investment Research
Detailed Data From NVS’ RemIND Study
Rhapsido is an oral, highly selective BTK inhibitor designed to block histamine release, a key driver of hives and swelling.
The phase III RemIND study (NCT05976243) is a global, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety and tolerability of Rhapsido in adults with CIndU that remains inadequately controlled despite treatment with H1-antihistamines.
The study’s primary endpoint is the proportion of patients achieving a complete response at week 12, measured using provocation tests specific to the three major CIndU subtypes. Secondary endpoints include changes from baseline in these measures at weeks 2 and 12, as well as the proportion of patients achieving complete responses at weeks 2 and 24.
The three most prevalent CIndU subtypes are SD, cold urticaria, and cholinergic urticaria.
Rhapsido met its primary endpoints across the three subtypes. The study also marked the first global phase III trial in CIndU to demonstrate efficacy across these subtypes. Higher rates of complete responses were observed at week 12, with symptom improvements seen as early as week 2 in two subtypes.
In the trial, complete response rates at week 12 were 29.3% versus 14.0% with placebo in SD, 56.3% versus 14.6% in cold urticaria, and 29.3% versus 15.8% in cholinergic urticaria. The results suggest that Rhapsido may offer sustained symptom relief for patients whose disease remains inadequately controlled with second-generation H1-antihistamines.
Novartis has submitted a supplemental new drug application (sNDA) to the FDA seeking approval of Rhapsido for the treatment of SD, the most common subtype of CIndU. The company also plans to pursue additional regulatory submissions worldwide throughout 2026.
Please note that Rhapsido is currently approved in the United States, European Union, China and several other markets for adults with chronic spontaneous urticaria whose symptoms remain inadequately controlled with H1-antihistamines.
Novartis is also evaluating the drug in other immune-mediated conditions, including hidradenitis suppurativa and food allergy.
Rhapsido continued to show strong early uptake in the United States and generated sales of $37 million in the first quarter of 2026, supported by a free drug program to facilitate patient access and increasing coverage.
Approval in other indications will bolster NVS’ immunology, which includes Cosentyx, Ilaris and Xolair. Novartis co-promotes Xolair with Roche in the United States and shares a portion of revenues as operating income but does not record any sales in the country.
NVS Looks to Strengthen Pipeline/Portfolio
2026 is a pivotal year for Novartis as it navigates the largest patent expiry in its history.
Novartis is now banking on key growth drivers — Kisqali, Kesimpta, Pluvicto, Scemblix and Leqvio — to support top-line growth.
Novartis AG Price, Consensus and EPS Surprise
Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote
NVS is also focusing on strategic acquisitions to strengthen its pipeline.
The company is all set to acquire SNV4818 from Synnovation Therapeutics, a pan-mutant selective PI3Kα inhibitor currently in phase I/II for HR+/HER2- breast cancer and other advanced solid tumors. The program aligns with Novartis’ breast cancer strategy and could be combined with CDK inhibitors and endocrine therapies. The deal is expected to be closed in the first half of 2026, subject to customary conditions.
Novartis agreed to acquire Excellergy, including Exl-111, a phase I anti-IgE antibody with extended half-life and high affinity. Its differentiated mechanism may enable faster and deeper receptor downregulation, potentially improving symptom control and dosing convenience in allergic diseases. The transaction is expected to be closed in the second half of 2026, subject to customary conditions.
NVS’ Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked biotech and large-cap pharma stocks are Immunocore (IMCR - Free Report) and Bayer AG (BAYRY - Free Report) . While IMCR sports a Zacks Rank #1 (Strong Buy), Bayer carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings per share (EPS) estimates for Immunocore have remained unchanged at 6 cents for 2026 and 87 cents for 2027.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 46.66%.
Shares of Bayer have gained 31.9% over the past year. Estimates for BAYRY’s 2026 EPS have increased from $1.20 to $1.25 over the past 60 days.