Latest news with #EczemaAreaandSeverityIndex
Yahoo
14-07-2025
- Business
- Yahoo
Canaccord Genuity Reiterated a Buy Rating on Apogee Therapeutics (APGE)
Apogee Therapeutics, Inc. (NASDAQ:APGE) is one of the . On July 7, analyst Edward Nash of Canaccord Genuity reiterated a Buy rating on Apogee Therapeutics, Inc. (NASDAQ:APGE) with a price target of $89. The reiterated bullish sentiment comes after the company released promising results from its APEX study for its drug APG777. The drug is an IL-13 monoclonal antibody aimed at treating atopic dermatitis. The Phase II study met its primary and secondary goals, showing a significant reduction in the Eczema Area and Severity Index score, which is a key measure of disease severity. Notably, improvement was seen as early as Week 2, indicating a strong drug effect. A scientist in a white lab coat working at a bench with biopharmaceutical equipment. Analyst Nash also highlights the ongoing Part B of the APEX study and expects 52-week maintenance data in early 2026. These data are important for confirming the drug's long-term benefits and dosing schedule, which could be quarterly to semi-annual. Apogee Therapeutics, Inc. (NASDAQ:APGE) is a clinical-stage biotech company developing novel biologic drugs for inflammatory and immunology diseases. While we acknowledge the potential of APGE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Time Business News
09-07-2025
- Health
- Time Business News
Breakthrough Innovations Transforming Eczema Therapeutics
Eczema therapeutics refer to the range of medical remedies and interventions designed to manage and relieve symptoms of eczema, which is a chronic inflammatory skin condition characterized by itching, redness, dryness and irritation. Eczema therapeutics are rapidly expanding in the market, which is powered by factors such as pollution, lifestyle changes and increased chemical risk due to the increasing proliferation of eczema. Development of advanced treatments, especially dupilumab such as biologics that target specific immune routes, are more effective and improve patient results with personal care. Additionally, more awareness, better healthcare access, and strong infrastructure are further enhancing market development. Key Growth Drivers and Opportunities Rise of Telemedicine and Mobile Health Apps: Eczema therapeutics are promoting the market by improving access to care, especially for patients in remote or underserved areas by improving access to care. These digital tools enable virtual consultation, real-time skin monitoring and individual treatment adjustment without in-tradition visit. They also support symptoms tracking, education and adherence to treatment through reminder, encouraging frequent care. This change for digital health increases the results and engagement of the patient when opening new channels to manage and distribute driving market growth, driving market growth. Challenges Eczema therapeutics faces several borders, including high cost of advanced treatments such as biologics, which can restrict access to many patients. Additionally, variability and potential side effects in the patient's response to therapy face challenges for effective management. Limited awareness in low income areas, lack of long -term treatment, and the root cause of treatment, instead of treatment, also obstructs market growth on symptomatic relief. Regulatory obstacles and slow approval procedures for new drugs carry forward innovation and availability. Innovation and Expansion Nektar Therapeutics Reveals Groundbreaking Eczema Therapy Following 'New Biology' Discovery In June 2025, After the biotech firm met all of its targets in a mid-stage study of its eczema medication, Nektar Therapeutics (NKTR) launched by triple digits. In order to treat inflammatory skin diseases and other autoimmune problems, Nektar has developed a novel biology and capitalized on the potential of regulatory T cell proliferators as a significant therapeutic approach. Three subcutaneous injections of Nektar's medication, rezpegaldesleukin, were administered to research participants. According to the Eczema Area and Severity Index, or EASI, patients' symptoms improved by 53% to 61% after 16 weeks. In contrast, the placebo group saw an improvement of 31%. As the Eczema Trial Draws to a Close, Turn Therapeutics Launches its Last Round of Crowdfunding and Collaborates with Clear Street on Public Market Strategies In April 2025, In addition to the impending start of a controlled clinical trial assessing its flagship, non-steroidal topical platform in patients with moderate to severe eczema, Turn Therapeutics, a clinical-stage biotechnology company that is leading the way in next-generation topical therapies, announced the opening of its final crowdfund investment round. As part of a larger strategic funding plan to finance late-stage studies throughout its therapeutic pipeline, Turn has also enlisted Clear Street to evaluate routes to the public markets. Over the course of an eight-week treatment period, Turn's forthcoming trial will evaluate the therapeutic performance of its unique mix, tracking decreases in itching and disease severity. Inventive Sparks, Expanding Markets Prominent players working in the eczema therapeutics manufacturing include Sanofi, Regeneron Pharmaceuticals Inc., Almirall, SA, UCB SA, NT-MDT SI and others. Investing in R&D to create sequential and targeted treatment, expanding market access through partnerships and digital health platforms, raising awareness and starting education campaigns to increase diagnosis rates, and to increase strength and access through partnership with payments with payments and healthcare providers around the world are important development strategies for all important development strategies for all important development strategies. About Author: Prophecy is a specialized market research, analytics, marketing and business strategy, and solutions company that offer strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high value opportunities in the target business area. Also, we help our client to address business challenges and provide best possible solutions to overcome them and transform their business. TIME BUSINESS NEWS
Yahoo
11-06-2025
- Health
- Yahoo
Regeneron and Sanofi's dupilumab shows promise in AD trial
Regeneron Pharmaceuticals and Sanofi have announced promising outcomes from the open-label Phase IV DISCOVER trial of Dupixent(dupilumab) in treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults with skin of colour. The data were presented at the 2025 Revolutionizing Atopic Dermatitis Conference. In the study, 120 subjects with AD and skin of colour received Dupixent biweekly. At the 24-week mark, 76% of them achieved a ≥75% improvement in overall disease severity, with some noticing benefits as early as two weeks. Additionally, 53% of patients saw a reduction in itch, and there was a 53% decrease in post-inflammatory hyperpigmentation from baseline. The trial's safety outcomes aligned with Dupixent's established safety profile in dermatological uses. Subjects in the DISCOVER trial, aged 12 years and above, were treated with Dupixent monotherapy based on weight. The primary endpoint was achieving a minimum of a 75% improvement on the Eczema Area and Severity Index (EASI-75) at 24 weeks. Secondary and additional endpoints are the proportion of subjects achieving ≥4-point improvement on the Peak-Pruritus Numerical Rating Scale (PP-NRS). The skin of colour was defined as per Fitzpatrick skin types IV-VI. AD, a chronic skin condition characterised by type 2 inflammation, can be particularly severe in individuals with skin of colour, often leading to more pronounced symptoms and skin lesions. Invented using Regeneron's VelocImmune technology, Dupixent is a monoclonal antibody that blocks the signalling of interleukin-4 and interleukin-13 pathways without being an immunosuppressant. It is a collaborative effort between Sanofi and Regeneron. The companies recently reported that the Phase III AERIFY-1 trial of itepekimab in former smokers who have inadequately controlled chronic obstructive pulmonary disease (COPD), met the primary goal. "Regeneron and Sanofi's dupilumab shows promise in AD trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Business Standard
04-06-2025
- Business
- Business Standard
SPARC tanks after psoriasis, eczema drug flunks Phase 2 trials
Sun Pharma Advanced Research Company (SPARC) dropped 18.63% to Rs 159.15 after the company announced disappointing results from a key clinical trial. In a regulatory filing, SPARC said that its partner, Sun Pharmaceutical Industries (SPIL), reported top-line results from Phase 2 studies of Vibozilimod (SCD-044), a drug candidate aimed at treating moderate-to-severe psoriasis and atopic dermatitis. Both trials failed to meet their primary endpoints: a 75% improvement in the Psoriasis Area and Severity Index (PASI75) and Eczema Area and Severity Index (EASI75), respectively, by Week 16. Following the setback, SPARC and SPIL stated they would assess the appropriate next steps for the development of Vibozilimod. SPARC is a clinical stage bio-pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. On a consolidated basis, SPARC reported net loss of Rs 59.77 crore in Q4 March 2025 as against net loss of Rs 105.79 crore in Q4 March 2024. Net sales rose 64.19% year-on-year to Rs 27.19 crore in Q4 March 2025.
Associated Press
04-06-2025
- Business
- Associated Press
Corvus Pharmaceuticals Announces Full Data from Cohort 3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
Cohort 3 demonstrates earlier and deeper responses compared to cohorts 1-2 All three cohorts show separation from placebo with statistically significant difference from placebo at day 28 Cohort 3 demonstrates clinically meaningful reduction in itch as early as day 8 Enrollment initiated in extension cohort study exploring the same cohort 3 dose (200 mg BID) for a longer 8-week treatment period SOUTH SAN FRANCISCO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data includes 28-day follow up results for all patients in cohort 3 and continues to show earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg). Overall, data from cohorts 1-3 of the trial have demonstrated a favorable safety and efficacy profile, including a statistically significant improvement in Eczema Area and Severity Index (EASI) score for the soquelitinib treated patients compared to placebo at day 28 (p=0.036). 'The complete 28-day data from cohort 3 of our Phase 1 trial of soquelitinib in patients with atopic dermatitis is in-line with the data update we provided at the Society for Investigative Dermatology meeting last month,' said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. 'We are encouraged that results from cohort 3 continue to show earlier and deeper responses, along with a reduction in itch, which is an important factor for patients. We look forward to exploring the potential for further improvement in patient results with longer treatment duration that is being studied in our recently initiated extension cohort. Overall, the data to date is supportive of our view that ITK inhibition with soquelitinib has the potential to be a safe, effective and convenient new option for patients with atopic dermatitis and other immune diseases.' Dr. Miller will highlight the new interim data in a presentation at the Jefferies Global Healthcare Conference, which is scheduled for 9:20 am ET / 6:20 am PT on Thursday, June 5, 2025. The live webcast, which will include presentation slides, may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus' website for 90 days. Soquelitinib Interim Data from the Atopic Dermatitis Phase 1 Clinical Trial As of May 28, 2025, enrollment in cohorts 1, 2 and 3 has been completed for a total of 48 patients and all patients (36 receiving soquelitinib and 12 placebos) had completed the 28-day treatment course. Patients in cohort 3 had more advanced disease with a higher mean baseline EASI score compared to patients in cohorts 1 and 2. At 28 days, the mean reduction in EASI for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12). The graphs below (Figures 1 and 2) show the kinetics of response for each of the cohorts and for the combined cohorts 1, 2 and 3. The placebo patients (n=4 per cohort, total n=12) are combined in both graphs. Separation of the curves for patients receiving active drug began at day 15 and increased by day 28 for cohorts 1 and 2. Cohort 3 patients experienced earlier and deeper separation from placebo starting by day 8. EASI scores continue to improve further in treated patients from all cohorts out to day 58. Figure 1: Percent Reduction in Mean EASI Score for Cohorts 1, 2 and 3 . Mean percent change in EASI score over time is shown. Treatment beginning is designated 'Baseline' and days post-baseline are shown. Screening to baseline data is shown and demonstrates relative disease stability. The study blinding remains in effect for the entire 58-day period. Numbers at the top of the graphs indicate numbers of patients evaluated at the various time points. Figure 2: Percent Reduction in Mean EASI Score for Combined Cohorts 1, 2 and 3. The data is displayed below with cohorts combined. Figure 3 below shows the percent of patients that achieved IGA (Investigator Global Assessment) 0 or 1 or EASI 75 at day 28 of treatment. The placebo patients from cohort 1 (n=4), cohort 2 (n=4) and cohort 3 (n=4) are combined, with no placebo patients achieving IGA 0 or 1 or EASI 75. IGA 0 or 1 and EASI 75 have been determined by the U.S. Food and Drug Administration (FDA) to be clinically meaningful and approvable endpoints and have been the endpoints used in clinical trials for other FDA approved treatments for atopic dermatitis. Four additional patients in cohort 3 are now included in the results as compared to the data reported at the Society for Investigative Dermatology (SID) annual meeting in May 2025 (SID data was as of May 6; these four patients had not yet completed the 28-day treatment course). One of the four patients achieved EASI 75 (this patient experienced an 89% reduction in EASI score) and IGA 1 at day 28 of treatment. Figure 3: Percent Patients Achieving Endpoints IGA 0 or 1, EASI 75 at Day 28 of Treatment Patient Reported Reductions in Itch Patients in the trial recorded the intensity of their pruritus, or itch, using the Peak Pruritus Numerical Rating Scale (PP-NRS), which rates the severity of itch on a scale from 0 (no itch) to 10 (the worst itch imaginable). A reduction of ≥4 points from baseline on the PP-NRS is considered to be a clinically meaningful result. In cohort 3, of the patients for whom adequate PP-NRS data was available, 4 of 8 (50%) had a ≥4 point reduction in PP-NRS score from baseline at day 28, with a reduction in itch seen as early as day 8. Of the remaining patients, two had baseline PP-NRS of less than 4 and two had incomplete PP-NRS data. 1 of 10 evaluable placebo patients (10%) experienced a ≥4 point reduction in PP-NRS score at Day 28. Safety Data As of May 28, 2025, no new safety signals have been observed. Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts. No interruption of drug dosing was seen in any of the cohorts. Grade 1/2 adverse events (treatment related and unrelated) were seen in 38.9% of patients receiving soquelitinib and 25% receiving placebo. Only one treatment related adverse event of grade 1 nausea was reported with soquelitinib treatment. Serum Cytokine and Other Biomarker Studies As reported previously, relationships between reductions in certain cytokines with improvement in EASI scores were observed. Reductions in serum cytokine levels were seen for IL-5, IL-9, IL-17, IL-31, IL-33, TSLP and TARC. Differences between responding and non-responding patients were found, while no such relationships were seen in the placebo group, and patients in cohort 3 had greater reductions in cytokines compared to cohorts 1 and 2. Increasing trends were seen in numbers of circulating T regulatory cells, consistent with the presumed mechanism of action of soquelitinib. Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Extension Cohort Corvus also announced that the first patient(s) has/have been enrolled in the recently announced extension cohort of the Phase 1 trial. This cohort is planned to enroll 24 patients randomized 1:1 between active and placebo, with patients in the treatment group receiving the same dose as cohort 3 – 200 mg orally twice per day. The treatment period for this group is 8 weeks, compared to 4 weeks in cohorts 1-3, with the same 30-day follow-up period with no treatment. About Corvus Pharmaceuticals Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company's lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit or follow the Company on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements related to the potential of the Company's product candidates including soquelitinib and the potential for further improvement in patient results in the extension cohort of the Phase 1 trial of soquelitinib in patients with atopic dermatitis, the design and planned enrollment of the extension cohort, data in support of ITK inhibition with soquelitinib and its potential for patients, and continued advancement of the Company's clinical pipeline. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as 'believe,' 'expect,' 'anticipate,' 'intend,' 'plan,' 'estimate,' 'seek,' 'will,' 'may' or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission on May 8, 2025, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company's ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company's ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. INVESTOR CONTACT: Leiv Lea Chief Financial Officer Corvus Pharmaceuticals, Inc. +1-650-900-4522 [email protected] MEDIA CONTACT: Sheryl Seapy Real Chemistry +1-949-903-4750 [email protected] Figures accompanying this announcement are available at:
