Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion Recommendation for adults and adolescents based on phase 3 studies showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the EU Paris and Tarrytown, September 22, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a p ...

Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion Recommendation for adults and adolescents based on phase 3 studies showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the EU Paris and Tarrytown, September 22, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a p ...

Core Insights - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and above, marking it as the first targeted medicine for CSU in over a decade in the EU [1][2][4] Group 1: Clinical Trials and Efficacy - Dupixent's positive CHMP opinion is based on data from two Phase 3 trials (Study A and Study C) that demonstrated significant reductions in itch and hives at 24 weeks compared to placebo [2] - A third trial (Study B) provided additional safety data for a different CSU patient population [2] Group 2: Safety Profile - The safety results from the trials were consistent with Dupixent's known safety profile, with adverse events more commonly observed including injection site reactions, COVID-19, hypertension, CSU, and accidental overdose [3] Group 3: Current Approvals and Market Presence - Dupixent is already approved for CSU in several countries, including Japan and the United States, with over 1,000,000 patients treated globally across various indications [4][7] - The Dupixent development program has involved over 60 clinical trials with more than 10,000 patients, focusing on diseases driven by type 2 inflammation [10] Group 4: Mechanism of Action - Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, which are key drivers of type 2 inflammation [6] Group 5: Future Developments - Regeneron and Sanofi are exploring Dupixent for additional indications related to type 2 inflammation, including chronic pruritus of unknown origin and lichen simplex chronicus, currently under clinical investigation [11]

Core Viewpoint - Analysts forecast Regeneron (REGN) will report quarterly earnings of $8.03 per share, reflecting a year-over-year decline of 30.5%, with anticipated revenues of $3.34 billion, a decrease of 5.7% compared to the previous year [1]. Earnings Estimates - The consensus EPS estimate has been revised downward by 6.5% over the past 30 days, indicating a collective reassessment by analysts [2]. - Revisions to earnings estimates are crucial indicators for predicting investor actions regarding the stock, with empirical research showing a strong correlation between earnings estimate trends and short-term stock price performance [3]. Revenue Forecasts - Analysts predict 'Revenues- Other Revenue' at $125.38 million, a year-over-year increase of 20% [5]. - 'Revenues- Net product sales' are expected to reach $1.46 billion, reflecting a decline of 23.9% year-over-year [5]. - 'Total Bayer collaboration revenue' is projected at $388.54 million, indicating a year-over-year increase of 3.6% [5]. - The consensus estimate for 'Revenues- Collaboration' stands at $1.73 billion, a year-over-year increase of 13.7% [6]. - 'Revenues- Eylea (Aflibercept)- US' are expected to be $1.03 billion, down 33% from the prior year [6]. - 'Revenues- Praluent (alirocumab)- US' are forecasted at $54.57 million, a decrease of 2.7% year-over-year [6]. Product-Specific Revenue Insights - 'Revenues- Libtayo- US' are estimated to reach $234.04 million, reflecting a year-over-year increase of 28.3% [7]. - 'Revenues- Evkeeza- US' are expected at $36.84 million, indicating an 18.8% year-over-year increase [7]. - 'Revenues- Dupixent (dupilumab)- ROW' are projected at $1.16 billion, a year-over-year increase of 22.7% [8]. - 'Revenues- Dupixent (dupilumab)- US' are expected to reach $3.05 billion, reflecting a year-over-year increase of 16.7% [8]. - 'Revenues- Kevzara (sarilumab)- ROW' are estimated at $47.83 million, indicating a year-over-year increase of 7.2% [9]. Market Performance - Over the past month, shares of Regeneron have returned +6.4%, outperforming the Zacks S&P 500 composite's +3.6% change [9].

Core Insights - The FDA has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP), a rare skin disease affecting approximately 27,000 adults in the U.S. [1][6] - Dupixent is now approved for eight distinct diseases related to type 2 inflammation, demonstrating its broad therapeutic potential [1][12]. Group 1: Approval and Clinical Data - The approval is based on pivotal results from the ADEPT Phase 2/3 trial, which showed significant improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo [1][5][7]. - In the trial, 18.3% of patients experienced sustained disease remission compared to 6.1% in the placebo group, indicating a 12.2% difference [5]. - Additionally, 38.3% of patients achieved clinically meaningful itch reduction compared to 10.5% in the placebo group [5]. Group 2: Patient Impact and Treatment Paradigm - Dupixent offers a novel treatment approach for elderly patients suffering from BP, who previously had limited therapeutic options [3][4]. - The drug targets two central drivers of type 2 inflammation, potentially allowing patients to achieve sustained remission and reduce itch [4][10]. - The approval reinforces Dupixent's safety profile across a broad age range, from infants to the elderly, and across various diseases [3][10]. Group 3: Regulatory and Market Context - The FDA evaluated Dupixent under Priority Review, indicating its potential for significant improvements in treating serious conditions [6]. - Dupixent has received regulatory approvals in over 60 countries for various indications, with more than 1,000,000 patients treated globally [12][29]. - The drug was previously granted Orphan Drug Designation by the FDA for BP, highlighting its importance in treating rare diseases [6].

Core Insights - Dupixent (dupilumab) has demonstrated superiority over Xolair (omalizumab) in treating chronic rhinosinusitis with nasal polyps (CRSwNP) in patients with coexisting asthma, as evidenced by the EVEREST phase 4 study results presented at the EAACI Annual Congress [1][4][6] Study Overview - The EVEREST study involved 360 adults with severe, uncontrolled CRSwNP and coexisting asthma, randomized to receive either Dupixent 300 mg every two weeks or omalizumab based on weight and IgE levels [2][6] - Both treatments were administered alongside mometasone furoate nasal spray [2] Efficacy Results - Dupixent showed a 1.60-point superior reduction in nasal polyp size (p<0.00011) and an 8.0-point superior improvement in the ability to identify different smells (p<0.00011) compared to omalizumab [5] - Other significant improvements included a 0.58-point reduction in nasal congestion (p<0.00011), a 1.74-point reduction in symptom severity (p<0.00011), and a 12.7-point difference in health-related quality of life (p<0.00012) [5] - Asthma-related endpoints also favored Dupixent, with a 150 mL difference in lung function (pre-bronchodilator FEV1; p=0.0032) and a 0.48-point difference in asthma control (p<0.00012) [5] Safety Profile - The safety results were consistent with the known profiles of both medications, with adverse events reported in 64% of Dupixent patients and 67% of omalizumab patients [3][4] - Serious adverse events occurred in 2% of Dupixent patients and 4% of omalizumab patients, while discontinuation due to adverse events was reported in 3% and 1% respectively [3][4] Mechanism of Action - Dupixent targets interleukin-4 (IL-4) and interleukin-13 (IL-13), which are key drivers of type 2 inflammation, reinforcing its efficacy in treating both upper and lower respiratory diseases [4][8] Regulatory Status - Dupixent has received regulatory approvals in over 60 countries for various indications, including CRSwNP, asthma, and other allergic conditions, with more than one million patients currently treated globally [9][10]

Core Insights - Dupixent has shown a significant efficacy in treating atopic dermatitis in patients with skin of color, achieving a 75% or greater improvement in overall disease severity in over 76% of treated patients [1][5] - The DISCOVER trial results highlight the importance of understanding chronic diseases in underserved populations, particularly in communities of color [1][2] Group 1: Clinical Trial Results - The DISCOVER Phase 4 trial involved 120 patients with atopic dermatitis and skin of color, with 82% being Black [2][5] - At 24 weeks, 76% of patients achieved a ≥75% improvement in overall disease severity (EASI-75), and 53% reported clinically meaningful improvement in itch [5][7] - Patients experienced a 53% reduction in post-inflammatory hyperpigmentation, with scores decreasing from 5.1 (moderate/marked) to 2.4 (mild) [5][6] Group 2: Safety Profile - The safety results from the DISCOVER trial were consistent with Dupixent's known safety profile, with an overall adverse event rate of 42% [3] - Common adverse events included headache (3%), upper respiratory tract infection (2%), and conjunctivitis (3%) [3] Group 3: Disease Characteristics - Atopic dermatitis presents differently in patients with skin of color, often leading to misdiagnosis or underestimation of disease severity [4] - Patients with darker skin tones are more likely to experience severe skin dryness, dyspigmentation, and hardened skin lesions compared to those with lighter skin [4] Group 4: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, addressing type 2 inflammation [8] - It has received regulatory approvals in over 60 countries for various indications, including atopic dermatitis and asthma, with over 1 million patients treated globally [9][11]

Core Insights - Regeneron Pharmaceuticals is set to present 24 abstracts on Dupixent at the American Thoracic Society International Conference 2025, focusing on its clinical data and real-world analyses in chronic obstructive pulmonary disease (COPD) and asthma [1][2][3] COPD Insights - The data from pivotal Phase 3 trials (BOREAS and NOTUS) will demonstrate Dupixent's effectiveness in reducing exacerbations and improving lung function in COPD patients, including those with and without emphysema [3][4] - The majority of patients in these trials had chronic bronchitis (≥95%) and over 30% had emphysema, with Dupixent showing sustained improvements in multiple spirometry measures over 52 weeks compared to placebo [3] - A late-breaking poster will present a win-ratio analysis assessing the likelihood of avoiding severe events such as death and hospitalization in COPD patients treated with Dupixent versus placebo [4] Asthma Insights - Late-breaking data will highlight Dupixent's impact on mucus burden and its efficacy in reducing exacerbations in children aged 6 to 11 years, regardless of disease duration [6][7] - The safety profile of Dupixent in asthma trials aligns with its known profile, with common adverse events including injection site reactions and viral infections [7] Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, addressing type 2 inflammation in various chronic diseases [13][14] - It has received regulatory approvals in over 60 countries for multiple indications, including COPD, asthma, and other allergic conditions, with more than 1 million patients currently treated globally [14][16] Development and Research - Dupixent is being jointly developed by Regeneron and Sanofi, with ongoing studies exploring its efficacy in a range of diseases driven by type 2 inflammation [16][17] - The Dupixent development program has involved over 60 clinical trials with more than 10,000 patients, demonstrating significant clinical benefits [16]

Core Viewpoint - Analysts expect Regeneron to report quarterly earnings of $8.76 per share, reflecting a year-over-year decline of 8.3%, with revenues projected at $3.25 billion, an increase of 3.3% from the previous year [1]. Earnings Estimates - The consensus EPS estimate has been revised 6.1% lower in the last 30 days, indicating a collective reevaluation by analysts [1][2]. - Changes in earnings estimates are crucial for predicting investor reactions, as empirical studies show a strong correlation between earnings estimate revisions and short-term stock performance [2]. Revenue Projections - Analysts predict 'Revenues- Other Revenue' to reach $132.13 million, a 13% increase year-over-year [4]. - 'Revenues- Net product sales' are expected to be $1.62 billion, indicating a decline of 8.2% from the previous year [4]. - 'Total Bayer collaboration revenue' is projected at $374.73 million, reflecting a 5.3% year-over-year increase [4]. - The consensus estimate for 'Revenues- Collaboration' stands at $1.49 billion, a 17.9% increase from the year-ago quarter [5]. Product-Specific Revenue Estimates - 'Revenues- Praluent (alirocumab)- US' are expected to be $57.71 million, down 17.6% year-over-year [5]. - 'Revenues- Eylea (Aflibercept)- US' are projected at $1.19 billion, indicating a decline of 15.2% [5]. - 'Revenues- Evkeeza- US' are estimated at $32.40 million, a 35% increase year-over-year [6]. - 'Revenues- Libtayo- ROW' are expected to reach $127.95 million, reflecting a 22.2% increase [6]. - 'Revenues- Libtayo- US' are projected at $214.99 million, indicating a 35% year-over-year increase [6]. - 'Revenues- Dupixent (dupilumab)- ROW' are expected to be $1.08 billion, a 25.7% increase [7]. - 'Revenues- Kevzara (sarilumab)- ROW' are projected at $41.91 million, down 5% year-over-year [7]. - 'Revenues- Kevzara (sarilumab)- US' are expected to reach $52.50 million, indicating a 5% increase [7]. Stock Performance - Over the past month, Regeneron shares have declined by 8.2%, compared to a 5.1% decline in the Zacks S&P 500 composite [8]. - Based on its Zacks Rank 4 (Sell), Regeneron is expected to underperform the overall market in the upcoming period [8].

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placeboIn the US, there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatmentCSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved Paris and Tarrytown, NY, April 18, 2 ...