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NVS Wins FDA Nod for Label Expansion of Immunology Drug Rhapsido
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Key Takeaways
Novartis' Rhapsido is now approved for both CSU and SD, the two most common forms of chronic hives.
Rhapsido delivered complete hive resolution in 29.3% of SD patients versus 14.0% for placebo at week 12.
NVS is testing Rhapsido in multiple sclerosis, hidradenitis suppurativa and food allergy for further growth.
Novartis (NVS - Free Report) received a key regulatory win for Rhapsido (remibrutinib) in the United States, with the FDA approving the oral Bruton’s tyrosine kinase (BTK) inhibitor for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines.
The approval expands Rhapsido’s commercial opportunity beyond chronic spontaneous urticaria (CSU) and strengthens Novartis’ position in the chronic hives market.
SD is the most prevalent form of chronic inducible urticaria, and more than half of patients continue to experience symptoms despite treatment with H1 antihistamines.
Rhapsido is now the only prescription treatment approved in the United States for both CSU and SD, the two most common forms of chronic hives.
The latest FDA approval was supported by results from the phase III RemIND trial. Rhapsido demonstrated a significantly higher rate of complete hive resolution than placebo in adults with SD who remained symptomatic despite second-generation H1 antihistamines.
At week 12, 29.3% of patients receiving Rhapsido achieved a complete response compared with 14% for placebo. Importantly, responses were observed as early as week 2, highlighting the potential for relatively rapid symptom relief.
Rhapsido’s safety profile in SD was consistent with that observed in CSU through week 24. Common adverse events included nasopharyngitis, bleeding, headache, nausea and abdominal pain.
Beyond SD, Novartis also evaluated remibrutinib in other forms of chronic inducible urticaria, including cold urticaria and cholinergic urticaria. The company plans to submit the complete RemIND study data to regulatory authorities worldwide, where appropriate.
Novartis is evaluating the drug in additional immune-mediated diseases, including hidradenitis suppurativa and food allergy. Novartis has also reported positive topline results from the phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis. Remibrutinib demonstrated a meaningful reduction in annualized relapse rates and delayed disability progression compared with teriflunomide, while maintaining a favorable safety profile.
Success in these additional indications could significantly expand the addressable market for remibrutinib and increase its strategic importance within Novartis’ immunology pipeline.
NVS Focuses on Strengthening Portfolio Amid Pipeline Setbacks
Novartis is working to strengthen its key portfolio as generic competition weighs on sales of blockbuster cardiovascular drug Entresto, while oncology drug Promacta is also facing generic pressure. Although strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is supporting the top line, the company’s pipeline will need to deliver meaningful new growth.
Recent clinical setbacks have raised concerns about the company’s ability to replenish growth and have weighed on investor sentiment.
Year to date, Novartis shares have gained 3.9% compared with the industry’s growth of 9.8%.
Image Source: Zacks Investment Research
The company suffered a notable setback after the late-stage HARBOR study of pelacarsen, which Novartis licensed from Ionis Pharmaceuticals (IONS), failed to meet its primary endpoint.
The study did not show a statistically significant reduction in major cardiovascular events compared with placebo.
Ionis Pharmaceuticals discovered pelacarsen and led its early development. In February 2019, Novartis exercised its option to license the rights to develop and commercialize pelacarsen as a targeted cardiovascular therapy.
Novartis also recently reported disappointing results from the phase III HARBOR study evaluating del-desiran in patients with myotonic dystrophy type 1. The candidate failed to demonstrate a statistically significant improvement over placebo on the primary endpoint of video hand opening time, adding another setback to the pipeline.
These failures highlight the risks associated with Novartis’ reliance on its pipeline to offset upcoming patent and generic pressures.
The recent FDA approval of Rhapsido for SD expands the drug’s addressable market and strengthens its potential as an immunology growth driver. Rhapsido’s favorable efficacy and safety profile, along with ongoing studies in multiple sclerosis, hidradenitis suppurativa and food allergy, could provide additional catalysts.
Over the past 60 days, estimates for Pfizer’s 2026 earnings per share have risen from $2.98 to $2.97, while estimates for 2027 have increased from $2.95 to $2.94 during the same time. PFE’s shares have surged 12.5% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.62%.
Shares of Bayer have gained 13.3% year to date. Estimates for BAYRY’s 2026 EPS have increased from $1.29 to $1.28 over the past 60 days.
View the Zacks #1 Rank List
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NVS Wins FDA Nod for Label Expansion of Immunology Drug Rhapsido
Key Takeaways
Novartis (NVS - Free Report) received a key regulatory win for Rhapsido (remibrutinib) in the United States, with the FDA approving the oral Bruton’s tyrosine kinase (BTK) inhibitor for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines.
The approval expands Rhapsido’s commercial opportunity beyond chronic spontaneous urticaria (CSU) and strengthens Novartis’ position in the chronic hives market.
SD is the most prevalent form of chronic inducible urticaria, and more than half of patients continue to experience symptoms despite treatment with H1 antihistamines.
Rhapsido is now the only prescription treatment approved in the United States for both CSU and SD, the two most common forms of chronic hives.
Strong Efficacy Supports NVS’ Rhapsido’s Label Expansion
The latest FDA approval was supported by results from the phase III RemIND trial. Rhapsido demonstrated a significantly higher rate of complete hive resolution than placebo in adults with SD who remained symptomatic despite second-generation H1 antihistamines.
At week 12, 29.3% of patients receiving Rhapsido achieved a complete response compared with 14% for placebo. Importantly, responses were observed as early as week 2, highlighting the potential for relatively rapid symptom relief.
Rhapsido’s safety profile in SD was consistent with that observed in CSU through week 24. Common adverse events included nasopharyngitis, bleeding, headache, nausea and abdominal pain.
Novartis AG Price, Consensus and EPS Surprise
Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote
NVS’ Efforts to Expand Rhapsido’s Label
Beyond SD, Novartis also evaluated remibrutinib in other forms of chronic inducible urticaria, including cold urticaria and cholinergic urticaria. The company plans to submit the complete RemIND study data to regulatory authorities worldwide, where appropriate.
Novartis is evaluating the drug in additional immune-mediated diseases, including hidradenitis suppurativa and food allergy. Novartis has also reported positive topline results from the phase III REMODEL-1 and REMODEL-2 trials in relapsing multiple sclerosis. Remibrutinib demonstrated a meaningful reduction in annualized relapse rates and delayed disability progression compared with teriflunomide, while maintaining a favorable safety profile.
Success in these additional indications could significantly expand the addressable market for remibrutinib and increase its strategic importance within Novartis’ immunology pipeline.
NVS Focuses on Strengthening Portfolio Amid Pipeline Setbacks
Novartis is working to strengthen its key portfolio as generic competition weighs on sales of blockbuster cardiovascular drug Entresto, while oncology drug Promacta is also facing generic pressure. Although strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is supporting the top line, the company’s pipeline will need to deliver meaningful new growth.
Recent clinical setbacks have raised concerns about the company’s ability to replenish growth and have weighed on investor sentiment.
Year to date, Novartis shares have gained 3.9% compared with the industry’s growth of 9.8%.
Image Source: Zacks Investment Research
The company suffered a notable setback after the late-stage HARBOR study of pelacarsen, which Novartis licensed from Ionis Pharmaceuticals (IONS), failed to meet its primary endpoint.
The study did not show a statistically significant reduction in major cardiovascular events compared with placebo.
Ionis Pharmaceuticals discovered pelacarsen and led its early development. In February 2019, Novartis exercised its option to license the rights to develop and commercialize pelacarsen as a targeted cardiovascular therapy.
Novartis also recently reported disappointing results from the phase III HARBOR study evaluating del-desiran in patients with myotonic dystrophy type 1. The candidate failed to demonstrate a statistically significant improvement over placebo on the primary endpoint of video hand opening time, adding another setback to the pipeline.
These failures highlight the risks associated with Novartis’ reliance on its pipeline to offset upcoming patent and generic pressures.
The recent FDA approval of Rhapsido for SD expands the drug’s addressable market and strengthens its potential as an immunology growth driver. Rhapsido’s favorable efficacy and safety profile, along with ongoing studies in multiple sclerosis, hidradenitis suppurativa and food allergy, could provide additional catalysts.
NVS’ Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the large-cap pharma sector are Pfizer (PFE - Free Report) and Bayer (BAYRY - Free Report) , currently carrying a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Pfizer’s 2026 earnings per share have risen from $2.98 to $2.97, while estimates for 2027 have increased from $2.95 to $2.94 during the same time. PFE’s shares have surged 12.5% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.62%.
Shares of Bayer have gained 13.3% year to date. Estimates for BAYRY’s 2026 EPS have increased from $1.29 to $1.28 over the past 60 days.