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Evommune Stock Cools Off After Big Rally On Successful Eczema Trial
Benzinga· 2026-02-12 14:46
Core Viewpoint - Evommune, Inc. shares experienced a decline due to profit-taking after a significant increase of approximately 70% following positive Phase 2a trial results for EVO301 in treating moderate-to-severe atopic dermatitis [1] Group 1: Trial Results - The Phase 2a trial of EVO301 demonstrated a 33% placebo-adjusted improvement in the Eczema Area and Severity Index (EASI) at week 12, with 23% of patients achieving a score of 0 or 1 on the Investigator's Global Assessment for Atopic Dermatitis [2] - The company plans to proceed to a Phase 2b dose-ranging trial with a subcutaneous formulation of EVO301 and is also exploring additional indications, including ulcerative colitis [2] Group 2: Analyst Insights - William Blair analysts noted that the trial results provide clear proof of concept for EVO301 in atopic dermatitis, which had previously been undervalued in Evommune's share price [3] - Analyst Matt Phipps raised the probability of success for EVO301 to 51% from 29% and increased the 2035 sales estimate to $1 billion from $760 million, suggesting that this estimate could be conservative if efficacy is shown in other diseases [4] Group 3: Stock Performance - Evommune shares were trading 5.1% below their 20-day simple moving average (SMA) and 2.7% below their 50-day SMA, indicating short-term weakness [5] - Despite recent volatility, the stock is trading 38.7% above its 20-day SMA and 45.3% above its 50-day SMA, reflecting a strong long-term trend [6] - Over the past 12 months, shares have decreased by 16.02% and are closer to their 52-week lows than highs, indicating potential challenges ahead [6] Group 4: Analyst Consensus - The stock is rated as a Strong Buy with an average price forecast of $44.17, and recent analyst actions include a Buy rating from HC Wainwright & Co. with a target raised to $65.00 [8][9] - At the time of publication, Evommune shares were down 3.62% at $27.43 [8]
Why Is Nektar Therapeutics Stock Gaining Wednesday?
Benzinga· 2026-02-11 12:35
Core Insights - Nektar Therapeutics' stock experienced a significant surge following the release of long-term data indicating that its experimental eczema therapy provides sustained and deepening disease control over one year, enhancing its competitive position in the atopic dermatitis market [1] Group 1: Clinical Data and Efficacy - The 36-week blinded maintenance period of the 52-week REZOLVE-AD study showed that the dosing regimens resulted in sustained disease control, with notable improvements in Eczema Area Severity Index (EASI) scores and Itch Numerical Rating Scale (NRS) responses [2][3] - A significant proportion of patients achieved new EASI-75, EASI-90, Itch NRS, and validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) responses at Week 52, indicating enhanced disease control with prolonged therapy and less frequent dosing [4] - Monthly maintenance dosing increased EASI-100 response from 4% to 22%, while quarterly dosing increased it from 9% to 18% among re-randomized patients [5] Group 2: Analyst Upgrades and Market Position - William Blair upgraded Nektar Therapeutics to Outperform, citing the deepening of response and durability of the therapy as key factors [6] - The analyst noted that approximately 20% of patients achieved complete disease clearance (EASI-100) after re-randomization, with about 30% achieving this among those who had a prior response [6] - EASI-75 and EASI-90 scores showed remarkable similarity, with quarterly dosing maintaining a higher response rate compared to competitor datasets [7] Group 3: Financial Developments - Nektar Therapeutics initiated a public offering to raise $300 million through equity [8] - The stock closed at $56.00, reflecting a 51.07% increase in regular trading, and continued to rise to $59.10 in early trading [8]
Press Release: Sanofi's amlitelimab confirms its potential in atopic dermatitis
Globenewswire· 2026-01-23 06:00
Core Insights - Amlitelimab shows promising results in treating moderate-to-severe atopic dermatitis (AD) in patients aged 12 years and older, supported by positive outcomes from two phase 3 studies, SHORE and COAST 2 [1][2] Study Results - In the SHORE study, amlitelimab met all primary and key secondary endpoints at Week 24, demonstrating significant efficacy compared to placebo [3][5] - The primary endpoint for SHORE was the proportion of patients achieving a validated investigator global assessment scale for AD (vIGA-AD) of 0 or 1, with a reduction from baseline score of ≥2 points [2][4] - In the COAST 2 study, amlitelimab met the primary endpoint for the US and US reference countries but did not achieve statistical significance for co-primary endpoints in the EU and EU reference countries [5][8] Efficacy Data - In the SHORE study, the proportion of patients achieving vIGA-AD 0/1 was 28.7% for Q4W dosing and 32.3% for Q12W dosing, both statistically significant [4] - The EASI-75 response rates were 48.1% for Q4W and 46.8% for Q12W, also showing statistical significance [4] - In the COAST 2 study, the vIGA-AD 0/1 rates were 25.3% for Q4W and 25.7% for Q12W, with EASI-75 rates of 41.8% and 40.5% respectively [9] Safety Profile - Amlitelimab was well-tolerated in both studies, with treatment-emergent adverse events (TEAEs) similar to placebo [12][13] - Common TEAEs in the SHORE study included nasopharyngitis (9.5% vs 12.5% in placebo) and upper respiratory tract infection (7.9% vs 4.4%) [12] - In the COAST 2 study, the most common TEAEs were nasopharyngitis (5.9% vs 7.4% in placebo) and upper respiratory tract infection (4.8% vs 4.0%) [13] Future Directions - Sanofi plans to move forward with global regulatory submissions for amlitelimab based on the totality of data from the studies [5] - Preliminary analysis from the ATLANTIS phase 2 study indicates continued improvements in skin clearance and disease severity beyond Week 24 [14][16] - Additional phase 3 studies, AQUA and ESTUARY, are expected to report results in H2 2026 [18]
New Published Data Confirms Nemluvio® (Nemolizumab) Can Rapidly Relieve Itch and Improve Sleep in as Early as Two Days in Both Atopic Dermatitis and Prurigo Nodularis
Financialpost· 2025-12-17 06:00
Core Insights - The studies ARCADIA 1 and 2 for atopic dermatitis and OLYMPIA 1 and 2 for prurigo nodularis show significant PP-NRS response at Day 2, highlighting nemolizumab's efficacy and its potential for rapid itch relief [1][1][1] Company Overview - Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. and is now exclusively developed and marketed by Galderma worldwide, except in Japan [1] - In Japan, nemolizumab is marketed as Mitchga® and is approved for treating prurigo nodularis and pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients [1][1] Regulatory Approvals - The U.S. FDA has approved Nemluvio for adults with prurigo nodularis and patients aged 12 years and older with moderate-to-severe atopic dermatitis, in conjunction with topical corticosteroids and/or calcineurin inhibitors when topical therapies are insufficient [1] - Nemluvio has received approval for moderate-to-severe atopic dermatitis and prurigo nodularis from multiple regulatory authorities globally, including the European Union, Australia, Singapore, Switzerland, and the United Kingdom [1][1]
Kymera Therapeutics Stock Soars 50% On Strong Atopic Dermatitis Trial Results
RTTNews· 2025-12-08 20:16
Core Viewpoint - Kymera Therapeutics (KYMR) experienced a significant stock price increase of 38.46 percent, rising $25.62 to $92.24 following the announcement of positive clinical results from its Phase 1b BroADen trial of KT-621, an oral STAT6 degrader for atopic dermatitis [1] Stock Performance - The current trading price of Kymera is $99.84, compared to a previous close of $66.62 on the Nasdaq [1] - The stock opened at $89.47 and has fluctuated between $86.84 and $103.00 during the trading session, with a trading volume of 5,319,985 shares [1] - The 52-week stock price range for Kymera is between $19.44 and $103.00 [1]
Apogee Therapeutics (NasdaqGM:APGE) FY Conference Transcript
2025-11-11 19:30
Summary of Apogee Therapeutics FY Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Industry**: Biopharmaceuticals, specifically focusing on antibody development for various indications including atopic dermatitis, asthma, and other conditions Core Strategy and Differentiation - Apogee is focused on developing best-in-class antibodies targeting large markets, with a lead program being a fully optimized IL-13 antibody for atopic dermatitis [4][5] - The company aims to improve dosing and efficacy through both monotherapies and combination approaches, with a goal of three to six-month dosing and optimized efficacy [5][6] - Apogee plans to initiate phase three trials next year, positioning itself ahead of competitors in the market [7][8] Market Dynamics and Competitive Landscape - The atopic dermatitis biologic market is growing at over 25% annually, with new-to-brand prescriptions increasing by 49% year-over-year [10][11] - Current biologic penetration in atopic dermatitis is only about 10%, indicating significant growth potential compared to other conditions like plaque psoriasis (25-30% penetration) and inflammatory bowel disease (60% penetration) [11] - Recent launches of competitors like Nemluvio and Ebglyss have shown promising sales, with Nemluvio annualizing at $500 million and Ebglyss at $650 million in their first year [10] Payer Environment and Access - Payers are providing first-line access to new biologics, with Nemluvio and Ebglyss achieving 80% and 90% coverage, respectively [13][14] - Apogee anticipates that its product will be preferred by both physicians and patients, driving prescription volume and payer access [14] Clinical Data and Product Development - Apogee's lead asset, APG 777, has shown promising phase 2a data, with a higher response rate (EASI 75) compared to competitors [16][17] - The company is exploring both three-month and six-month dosing regimens, with plans to gather data to inform phase three trials starting in the second half of 2026 [22][23] - The company is also investigating the efficacy of APG 777 in asthma, with a focus on FeNO as a biomarker for response [27][28] Combination Therapies and Future Directions - Apogee is developing combination therapies with TSLP and OX40L, aiming for co-formulation to enhance dosing frequency and efficacy [31][32] - The company is cautious about the crowded landscape for TSLP therapies and is focusing on combination approaches rather than monotherapy [30][31] - Apogee's strategy includes running active comparator studies to establish its products as frontline therapies [36][37] Conclusion - Apogee Therapeutics is positioned for a busy 2026 with multiple catalysts on the horizon, including phase three trials and potential product launches [40]
Turn Therapeutics’ GX-03 Technology Named as One of “Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment” by Patient Care Online Magazine
Globenewswire· 2025-11-11 13:00
Core Insights - Turn Therapeutics Inc. has been recognized as one of the "Five Novel Mechanisms Reshaping Atopic Dermatitis Treatment" by Patient Care Online Magazine, highlighting its innovative approach in the dermatology sector [1][2] Company Overview - Turn Therapeutics is a biotechnology company focused on developing and commercializing products for dermatology, wound care, and infectious diseases [3] - The company has received three FDA clearances for its proprietary formulations in wound and dermatology care and is advancing late-stage clinical programs in eczema and onychomycosis [3] - Turn is also engaged in global health initiatives, particularly in thermostable vaccine delivery aimed at underserved areas, reflecting its commitment to public health innovation [3] Product Development - The company's GX-03 technology targets IL-36, which is involved in the inflammatory processes of atopic dermatitis, eczema, and psoriasis, representing a novel topical agent that offers an alternative to systemic and injectable treatments [2] - Studies have shown that GX-03 can inhibit several key targets, including IL-36 alpha, IL-31, IL-4, and IL-36 gamma, all associated with eczema and psoriasis [2] - Turn Therapeutics is expected to announce topline data from its lead program in severe eczema in early 2026 [2]
Arcutis to Present New Quality of Life and Long-Term Data with ZORYVE® (roflumilast) Cream 0.15% and 0.05% for the Treatment of Atopic Dermatitis at the Fall Clinical Dermatology Conference
Globenewswire· 2025-10-24 12:00
Core Insights - Arcutis Biotherapeutics announced new data on ZORYVE® (roflumilast) cream, showing improvements in quality of life for atopic dermatitis patients, particularly in reducing sleep disruptions and providing long-term disease control for individuals aged 2 years and older [1][2][5] Clinical Data - ZORYVE cream demonstrated significant improvements in sleep and itch reduction in patients aged 2 to 5 years and 6 years and older, based on patient-reported outcomes from three Phase 3 trials [3][6] - The treatment was well-tolerated, with adverse events reported in ≤6% of patients, and serious adverse events in <1% [6][12] Long-term Efficacy - Long-term data from the INTEGUMENT-OLE trial indicated that ZORYVE cream maintained or improved disease control over 56 weeks, with a notable percentage of patients achieving 'Clear' or 'Almost Clear' status [8][12] - The median duration of disease control for patients switching to twice-weekly treatment was 238 days for children aged 2-5 and 281 days for older patients [12] Product Recognition - ZORYVE has received multiple awards, including the "2025 Best of Beauty Breakthrough Award" from Allure and the National Psoriasis Foundation's Seal of Recognition, highlighting its clinical impact and industry recognition [10] Indications and Usage - ZORYVE cream is indicated for the topical treatment of mild to moderate atopic dermatitis in pediatric patients aged 2 to 5 years and in patients aged 6 years and older [11][13]
Marking Eczema Awareness Month – Clinical Research Validates Strata Skin Sciences' XTRAC® Excimer Laser as a Breakthrough Therapy for Localized Atopic Dermatitis
Globenewswire· 2025-10-03 14:50
Core Insights - STRATA Skin Sciences emphasizes the effectiveness of the XTRAC Excimer Laser for treating localized atopic dermatitis, supported by extensive clinical evidence [1][4] - The American Medical Association has expanded the excimer laser's indications, facilitating reimbursement for atopic dermatitis treatment through Medicare, Medicaid, and private payers [1] Company Overview - STRATA Skin Sciences is a medical technology company focused on innovative products for dermatologic conditions, including psoriasis, vitiligo, and acne [7] - The company offers a unique Partnership Program that includes a fee per treatment cost structure, on-site training, and marketing support [8] Market Context - Atopic dermatitis affects over 9.6 million children and 16.5 million adults in the U.S., significantly impacting their daily lives and emotional well-being [3] - Despite its prevalence, many patients face challenges with limited treatment options [3] Clinical Evidence - A study showed that excimer laser therapy resulted in an 81% reduction in itching intensity after one month, with significant quality-of-life improvements [5] - Another trial indicated that excimer laser treatment provided longer-lasting results compared to traditional steroid therapy, positioning it as a viable steroid-sparing option [5] - A pivotal study reported a 69% reduction in disease severity and 87% of patients achieving clear or almost clear skin after treatment [5] Treatment Advantages - The XTRAC Excimer Laser directly targets diseased skin while sparing healthy tissue, making it particularly effective for difficult areas like hands and feet [10] - The treatment offers lower UV exposure compared to whole-body phototherapy and provides shorter treatment regimens with long-lasting remission [10]
Nektar Therapeutics (NASDAQ:NKTR) Sees Promising Clinical Results
Financial Modeling Prep· 2025-09-19 04:00
Core Viewpoint - Nektar Therapeutics (NKTR) is experiencing significant stock price growth due to positive clinical trial results for its drug rezpegaldesleukin, aimed at treating atopic dermatitis, with a price target set at $99 by Jefferies analyst Roger Song, indicating a potential increase of 68.54% from its current price of $58.74 [1][2][6] Group 1: Stock Performance - NKTR's stock price surged over 15% following the announcement of positive phase 2b study results for rezpegaldesleukin [2][6] - The current stock price is $58.76, with a market capitalization of approximately $1.12 billion, marking its highest price over the past year [5][6] - The stock has fluctuated between a low of $52.13 and a high of $58.81 today, with the lowest price in the past year being $6.45, indicating significant growth potential [5] Group 2: Clinical Research Findings - The phase 2b study of rezpegaldesleukin demonstrated that it met its primary and key secondary endpoints at week 16, showing statistical significance in improving the eczema area and severity index compared to a placebo [3][6] - Interim data for patients who switched from a placebo to a 24-week high dose treatment showed an EASI-75 response deepening to 62% and a vIGA-AD 0/1 response increasing to 38% [4][6] - These findings were presented at the 2025 European Academy of Dermatology and Venereology Congress, highlighting the drug's potential in treating atopic dermatitis [3][4]