I&I News

A study presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting indicates that switching from medium-dose inhaled corticosteroids (ICS) to biologics for asthma treatment significantly reduces exacerbation episodes. The research analyzed data from patients aged 12 and older who transitioned to either gh-dose ICS or biologics, revealing that those who started biologics experienced a notable decrease in exacerbation rates and systemic corticosteroid prescriptions. Specifically, patients on dupilumab saw a 65% reduction in exacerbations, while those on omalizumab and anti-IL-5 biologics had reductions of 32% and 44%, respectively. In contrast, the gh-dose ICS group had a smaller 14% reduction. The findings suggest that for patients with severe asthma or gh type 2 comorbidity burden, direct escalation to biologics may be more beneficial than increasing ICS dosage. Further analysis is needed to adjust for baseline characteristics among the biologic groups to draw more definitive conclusions.

Read full article: https://www.healio.com/news/pulmonology/20260408/asthma-exacerbation-episodes-drop-with-transition-from-mediumdose-ics-to-biologic

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Following a formulary change by CVS, prescriptions for adalimumab biosimilars saw a significant initial increase of nearly 25%, but this surge was not sustained. Data from the Rheumatology Informatics System for Effectiveness (RISE) registry indicated that while new users of adalimumab biosimilars rose from 0% to 24% after the change, this figure dropped to 10% in the subsequent month. The study ghlighted the potential influence of the 'nocebo effect,' where negative expectations may lead patients to revert to the original adalimumab. Researchers noted that despite the biosimilars having similar product characteristics to the originator, clinician and patient trust in biosimilars is crucial for their successful adoption. The findings suggest that the anticipated impact of the CVS formulary change on biosimilar usage has not materialized as expected, with a noted decrease in overall biosimilar prescriptions following the initial rise.

Read full article: https://www.healio.com/news/rheumatology/20260403/rapid-increase-in-humira-biosimilar-orders-after-cvs-formulary-change-not-sustained

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Immunic, Inc., a late-stage biotechnology company, announced its participation in two upcoming scientific and medical conferences in April 2026. The first event is the 8th Annual Neuroimmunology Drug Development Summit in Boston, where Chief Scientific Officer Hella Kohlhof, Ph.D., will present on the company's lead asset, vidofludimus calcium (IMU-838), which is in phase 3 clinical trials for relapsing multiple sclerosis. The second event is the 2026 American Academy of Neurology Annual Meeting in Chicago, where Immunic's team will be available at booth . Vidofludimus calcium is noted for its neuroprotective and anti-inflammatory properties, and the company is also developing other programs targeting neurodegenerative and autoimmune diseases. Top-line data from the phase 3 trials is expected by the end of 2026.

Read full article: https://www.prnewswire.com/news-releases/immunic-to-participate-in-scientific-and-medical-conferences-in-april-302736609.html

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The American Academy of Dermatology (AAD) has published its first-ever guidelines for the prevention and management of pediatric atopic dermatitis (eczema), recognizing the unique needs of children under 18. The guidelines, developed by a group of 14 experts, emphasize that while eczema is common in children, dietary and environmental interventions have insufficient evidence for prevention. Moisturizers are recommended for reducing eczema occurrence in young children, while various treatments, including topical calcineurin inhibitors, corticosteroids, and monoclonal antibodies, are suggested for managing symptoms. The guidelines aim to educate patients and caregivers, promoting early intervention to improve quality of life for affected children. The AAD's guidelines reflect advancements in eczema care and are intended to ensure optimal treatment for pediatric patients.

Read full article: https://www.biospace.com/press-releases/c-o-r-r-e-c-t-i-o-n-american-academy-of-dermatology

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Lynk Pharmaceuticals has announced the acceptance of its New Drug Application (NDA) for zemprocitinib capsules by the China National Medical Products Administration (NMPA) for the treatment of moderate-to-severe atopic dermatitis. This milestone is significant for the company's development in inflammatory skin diseases and aims to address unmet medical needs in patients who have inadequate responses to existing treatments. The NDA is supported by positive results from a Phase III clinical trial, which showed statistically significant improvements in key endpoints compared to placebo, along with a favorable safety profile. Zemprocitinib is a second-generation selective JAK1 inhibitor, with ongoing trials for other conditions such as rheumatoid arthritis and ankylosing spondylitis. Lynk Pharmaceuticals, founded by former executives from major pharmaceutical companies, focuses on innovative therapies for immune and inflammatory diseases.

Read full article: https://www.prnewswire.com/apac/news-releases/lynk-pharmaceuticals-announces-nda-acceptance-for-zemprocitinib-by-nmpa-302738518.html

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Innovent Biologics presented preclinical results for IBI3055, a tri-specific T cell engager targeting autoimmune diseases, at the 2026 Immune Resetting Summit in Boston. IBI3055 targets CD19, BCMA, and CD3, utilizing a unique '1+1+1' design with CD3 masking to minimize non-specific T-cell activation. The data indicates that IBI3055 effectively depletes B cells and plasma cells in various models, showing comparable potency to mono-targeting T cell engagers while demonstrating favorable safety and tolerability. The company emphasizes the need for innovative therapies in treating B cell- or plasma cell-mediated autoimmune diseases, aiming to balance efficacy with tolerability. Innovent, founded in 2011, focuses on developing gh-quality biopharmaceuticals across multiple disease areas and has launched 18 products to date.

Read full article: https://www.prnewswire.com/news-releases/immune-resetting-b-cell-mediated--beyond-summit-2026-oral-presentation-innovent-biologics-announces-pre-clinical-results-of-ibi3055-a-tri-specific-t-cell-engager-targeting-autoimmune-diseases-302738492.html

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Kyverna Therapeutics, a late-stage clinical biopharmaceutical company, announced it will host a conference call on April 22, 2026, to discuss data from its KYSA-8 trial of miv-cel (mivocabtagene autoleucel) in stiff person syndrome and follow-up data from the KYSA-6 Phase 2 trial in generalized myasthenia gravis. These findings will be presented at the American Academy of Neurology Annual Meeting in Chicago from April 18-22, 2026. Miv-cel is a CD19-targeting CAR T-cell therapy under investigation for autoimmune diseases, with the potential to provide durable remission. Currently, there are no FDA-approved treatments for stiff person syndrome, and treatment options for generalized myasthenia gravis often require chronic immunosuppressive therapy. Kyverna aims to advance its neuroimmunology franchise and explore additional studies in related autoimmune conditions.

Read full article: https://www.biospace.com/press-releases/kyverna-therapeutics-to-host-conference-call-on-new-data-across-neuroimmunology-franchise-at-aan-2026

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Q32 Bio Inc., a clinical stage biotechnology company focused on therapies for alopecia areata and other autoimmune diseases, announced its participation in the 25th Annual Needham Virtual Healthcare Conference on April 15, 2026. The company's management will engage in a fireside chat at 12:45 p.m. E.T., with a webcast available on their website. Q32 Bio is advancing bempikibart (ADX-914), an anti-IL-7Rα antibody, in an ongoing Phase 2 program for alopecia areata, a condition affecting approximately 700,000 people in the U.S. The company emphasizes the importance of its website and social media for investor communications and material information dissemination.

Read full article: https://www.prnewswire.com/news-releases/q32-bio-to-participate-in-the-25th-annual-needham-virtual-healthcare-conference-302736130.html

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Insmed has decided to discontinue the development of its lung disease drug Brinsupri for the treatment of dradenitis suppurativa after a Phase 2b study, known as CEDAR, showed disappointing results with no efficacy signal. The study revealed that the placebo group outperformed both doses of Brinsupri tested, leading analysts to express little surprise at the outcome. This decision allows other companies, such as Incyte, Novartis, and UCB, to advance their own treatments for the skin condition, which have recently achieved clinical and regulatory successes. Brinsupri, which is approved for non-cystic fibrosis bronchiectasis, had previously failed in a mid-stage trial for chronic rhinosinusitis. Insmed's recent sales for Brinsupri in bronchiectasis were strong, totaling $144.6 million in its first full quarter of sales.

Read full article: https://www.biospace.com/drug-development/insmed-scraps-skin-plans-for-lung-disease-drug-as-competitors-make-headway

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Amlitelimab, an OX40 inhibitor developed by Sanofi, has shown significant improvements in skin clearance for adolescents and adults with moderate to severe atopic dermatitis, according to results presented at the American Academy of Dermatology Annual Meeting. In a phase 2b study, participants demonstrated progressive improvements in IGA and EASI scores, with effects maintained even after discontinuation of the drug. The COAST-1, COAST-2, and SHORE studies involved over 1,800 participants and indicated that a gher percentage achieved clear or almost clear skin compared to placebo. Amlitelimab was well tolerated, with low rates of adverse effects, including conjunctivitis and headache. Ongoing studies will further investigate the durability of response and safety profile of amlitelimab, particularly in light of safety concerns raised by other OX40 inhibitors. The findings suggest potential for long-term management of atopic dermatitis with amlitelimab.

Read full article: https://www.healio.com/news/dermatology/20260407/durable-progressive-eczema-improvement-seen-with-ox40-inhibitor-amlitelimab

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Sanofi's lunsekimig has shown promising results in phase 2 studies for treating moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), meeting primary and key secondary endpoints in both the AIRCULES and DUET studies. The AIRCULES study demonstrated significant reductions in asthma exacerbations and improvements in lung function, while the DUET study showed positive changes in nasal polyp scores and patient-reported symptoms. However, the exploratory VELVET study for moderate-to-severe atopic dermatitis did not meet its primary endpoint, although some secondary endpoints showed improvement. Lunsekimig, a bispecific Nanobody designed to block TSLP and IL-13, was generally well tolerated across all studies. Further results will be presented at upcoming medical congresses, and lunsekimig is currently undergoing additional clinical trials.

Read full article: https://www.globenewswire.com/news-release/2026/04/07/3268809/0/en/press-release-sanofi-s-lunsekimig-met-primary-and-key-secondary-endpoints-in-phase-2-respiratory-studies-in-asthma-and-crswnp.html

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Alumis Inc. (NASDAQ: ALMS) received positive evaluations from Raymond James and Guggenheim following the presentation of its Phase 3 trial data for envu at the American Academy of Dermatology meeting. Raymond James maintained a Strong Buy rating with a price target of $46, ghlighting the favorable safety profile of envu compared to Takeda Pharmaceutical's zasocitinib, which exhibited gher rates of adverse events. Guggenheim also reiterated a Buy rating with a price target of $32. Alumis is focused on developing targeted therapies for immune-mediated diseases using its proprietary data analytics platform.

Read full article: https://www.insidermonkey.com/blog/raymond-james-and-guggenheim-stay-bullish-on-alumis-alms-after-trial-results-1732809/?amp=1

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Autolus Therapeutics plc, a biopharmaceutical company focused on next-generation programmed T cell therapies, announced its participation in two upcoming investor conferences. The 25th Annual Needham Virtual Healthcare Conference is scheduled for April 13, 2028, where CEO Dr. Christian Itin will present. A webcast of the presentation will be available on the company's website. Additionally, the company will host investor meetings at the Van Lanschot Kempen Life Sciences Conference on April 16, 2026, in Amsterdam. Autolus is known for its marketed therapy AUCATZYL® and is developing therapies for cancer and autoimmune diseases using proprietary T cell programming technologies.

Read full article: https://finance.yahoo.com/sectors/healthcare/articles/autolus-therapeutics-participate-upcoming-investor-110000118.html

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Climb Bio, Inc. announced that the U.S. FDA has granted Fast Track Designation to its investigational anti-CD19 monoclonal antibody, budoprutug, for treating primary membranous nephropathy (pMN), a rare kidney disease with no FDA-approved treatments. The designation acknowledges the urgent need for new therapies and the promising early clinical results of budoprutug, which showed complete B-cell depletion and clinical remission in a Phase 1b study. Climb Bio is currently conducting a Phase 2 global study to further evaluate budoprutug's efficacy and pharmacodynamics in pMN patients. The company plans to share initial data from this study in the second half of 2026. Budoprutug has also received Orphan Drug Designation from the FDA for pMN treatment.

Read full article: https://www.globenewswire.com/news-release/2026/04/07/3268966/0/en/climb-bio-announces-fda-fast-track-designation-for-budoprutug-for-the-treatment-of-primary-membranous-nephropathy.html

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MoonLake Immunotherapeutics has reported long-term results from its Phase 3 VELA-1 and VELA-2 trials for sonelokimab in treating moderate-to-severe dradenitis suppurativa, demonstrating sustained clinical responses and quality-of-life improvements without new safety concerns. The Week 40 outcomes may establish a new standard for long-term lesion control compared to existing IL-17 treatments. The company is focused on upcoming milestones, including a 52-week readout and a potential BLA filing in late 2026, which could influence investor confidence. However, MoonLake remains unprofitable and dependent on future clinical and regulatory successes to validate its current valuation. Analysts suggest that the stock may be overvalued based on its financials, with a fair value estimate around $26.71 per share. The article emphasizes the importance of considering multiple perspectives before making investment decisions regarding MoonLake Immunotherapeutics.

Read full article: https://finance.yahoo.com/sectors/healthcare/articles/investors-reacting-moonlake-immunotherapeutics-mltx-071047809.html

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Nektar Therapeutics (NKTR) recently presented Phase 2b data for its biologic rezpegaldesleukin, aimed at treating atopic dermatitis and alopecia areata, at the 2026 American Academy of Dermatology meeting. The company plans to initiate a Phase 3 program for atopic dermatitis in Q2 2026. However, Nektar is facing multiple securities class action lawsuits related to its REZOLVE-AA trial, which raises concerns about trial integrity and management. The Phase 2b results showed consistent improvements in EASI scores, supporting the upcoming Phase 3 launch, but the ongoing litigation could undermine investor confidence. Analysts project significant revenue and earnings growth by 2029, but the success of rezpegaldesleukin is critical amid the legal challenges. The article emphasizes the importance of evaluating both the promising data and the risks associated with the lawsuits as Nektar moves forward.

Read full article: https://finance.yahoo.com/sectors/healthcare/articles/nektar-therapeutics-nktr-12-1-130539867.html

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