Kymera Therapeutics Announces Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

manilatimes.net · Feb 26, 2026 · Collected from GDELT

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February 26, 2026 KT-621 (STAT6) BROADEN2 Phase 2b trial in atopic dermatitis (AD) ongoing, with data expected by mid-2027 KT-621 BREADTH Phase 2b trial in asthma ongoing, with data expected in late-2027Initiated dosing in KT-579 (IRF5) Phase 1 healthy volunteer trial with data expected in 2H26 Dr. Neil Graham, experienced biopharma leader, appointed Chief Development Officer Well-capitalized with $1.6 billion in cash as of December 31, 2025, and runway into 2029 Get the latest news delivered to your inbox Sign up for The Manila Times newsletters By signing up with an email address, I acknowledge that I have read and agree to the Terms of Service and Privacy Policy. Company to hold video conference call and webcast today at 8:30 a.m. ETWATERTOWN, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business highlights and updates on its pipeline. "We set a high bar for what we wanted to achieve in 2025 and exceeded expectations. We enter this year with momentum and focus as we continue to advance an innovative and robust pipeline, anchored by our STAT6 program,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "Across many immuno-inflammatory diseases, patients face tradeoffs, often compromising on efficacy, safety, or convenience. We see an opportunity to change the status quo. With highly encouraging Phase 1b data in atopic dermatitis demonstrating consistent impact across every measure evaluated, and two parallel Phase 2b studies now underway in atopic dermatitis and asthma, KT-621 highlights the opportunity to meaningfully expand the reach to patients who need and deserve treatment, move therapy earlier in the disease journey, and ultimately improve outcomes for millions of patients.”Dr. Mainolfi continued, "We also initiated dosing in the first-in-human Phase 1 healthy volunteer trial for KT-579, the first IRF5-directed mechanism to enter the clinic and a completely novel oral approach to addressing key drivers of multiple debilitating autoimmune conditions. Additionally, with our highly productive small molecule discovery engine, we’re poised to share at least one new high-value program later this year. All these exciting milestones underscore our momentum and commitment to transforming how common, lifelong immunological diseases are treated.” Business Highlights, Recent Developments and Upcoming Milestones STAT6 Degrader Program KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Type 2 inflammation, and currently in Phase 2 clinical testing in atopic dermatitis (AD) and asthma. In the Phase 1 clinical study in AD patients, KT-621 demonstrated deep STAT6 degradation in blood and skin, robust reductions in disease-relevant Type 2 inflammatory biomarkers, meaningful improvements on clinical endpoints and patient-reported outcomes in AD and comorbid asthma and allergic rhinitis, and was well tolerated with a favorable safety profile. KT-621, the first STAT6-directed drug to enter clinical evaluation, has the potential to transform treatment for more than 140 million patients around the world suffering from Type 2 diseases such as AD, asthma, chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis (EoE), chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), prurigo nodularis (PN), and bullous pemphigoid (BP), among others. In January 2026, the Company expanded the KT-621 BROADEN2 Phase 2b clinical trial to include adolescents, in addition to adults. BROADEN2 is a global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety, and tolerability of three doses of KT-621 in approximately 200 patients ages 12 to 75 with moderate to severe atopic dermatitis over 16 weeks. The primary endpoint is the percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 16. Secondary endpoints will evaluate additional safety, efficacy, and quality-of-life measures. Recruitment is ongoing, with enrollment expected to be completed in 2026 and data reported by mid-2027. In January 2026, the Company commenced dosing in the BREADTH Phase 2b clinical trial, a global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of three doses of KT-621 in approximately 264 adult patients with moderate to severe eosinophilic asthma over 12 weeks. The primary endpoint is the change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1). Secondary endpoints will evaluate a range of additional safety, efficacy, and quality of life measures. Recruitment is ongoing, with data expected to be reported in late-2027. The Company recently completed the six- to nine-month GLP chronic toxicology studies in rat and NHP and did not observe any adverse findings across all doses and concentrations tested, consistent with earlier KT-621 toxicology studies. In December 2025, the Company reported positive results from the KT-621 BroADen Phase 1b clinical trial in moderate to severe AD patients. After 28 days of daily oral dosing, KT-621 demonstrated consistent impact across each measure evaluated in the trial. KT-621 showed deep STAT6 degradation in blood and skin, robust reductions in disease-relevant Type 2 inflammatory biomarkers in blood, skin and lungs, and meaningful improvements in clinical endpoints and patient-reported outcomes on signs and symptoms in atopic dermatitis as well as comorbid asthma and allergic rhinitis, with a favorable safety and tolerability profile. The impact on biomarkers and clinical endpoints was in line or numerically exceeded data reported from dupilumab studies after 4 weeks of treatment.In December 2025, the U.S. Food and Drug Administration granted Fast Track designation to KT-621 for the treatment of moderate to severe AD.IRF5 Degrader Program KT-579 is an investigational, first-in-class, oral degrader of IRF5, a genetically validated transcription factor and master regulator of immunity, and currently in Phase 1 testing. KT-579 has the potential to selectively block inflammation and restore immune regulation by inhibiting pro-inflammatory cytokines, Type I IFN, and autoantibody production while sparing normal cell function. In preclinical studies, KT-579 degraded IRF5 across multiple preclinical species and in all disease-relevant tissues. In preclinical models of lupus and rheumatoid arthritis (RA), KT-579 activity was equal to or more efficacious than small molecule inhibitors and biologics currently marketed or in the clinic. In preclinical safety studies, KT-579 did not show any adverse effects of any type at all doses and concentrations tested. KT-579 has the potential to be the first novel mechanism with broad utility in diseases where effective and well tolerated oral therapies are needed, such as lupus, Sjögren's, inflammatory bowel disease (IBD), RA and others. In February 2026, the Company, after IND-clearance from the FDA, commenced dosing in the first-in-human KT-579 Phase 1 clinical trial in healthy volunteers. The Phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of orally administered KT-579 compared to placebo. The key study aim is to show that KT-579 can robustly degrade IRF5 in blood at doses that are safe and well-tolerated. The functional impact of IRF5 degradation on the induction of Type I interferons, proinflammatory cytokines, and inflammatory pathway gene transcripts by TLR 7/8/9 agonists will also be assessed with whole blood ex vivo stimulation assays. The Company expects to report data from the trial in the second half of 2026.In October 2025, the Company presented two preclinical posters at the American College of Rheumatology (ACR) Annual Meeting. The new data demonstrated KT-579’s activity in additional preclinical efficacy models of lupus and RA, further supporting IRF5 degradation as a first-in-class mechanism to address B cell activation as well as autoantibody and pro-inflammatory cytokine production in multiple autoimmune diseases.Partnered Programs KT-485/SAR447971, a selective, potent, oral IRAK4 degrader being advanced in partnership with Sanofi for immuno-inflammatory diseases, has completed IND-enabling studies, with clinical entry expected in 2026.Preclinical activities are ongoing under an exclusive option and license agreement with Gilead Sciences to advance the Company's oral CDK2 molecular glue program for the potential treatment of breast cancer and other solid tumors. Upon exercise of Gilead’s option, which would result in an option exercise payment to Kymera, Gilead would assume all responsibility to develop, manufacture and commercialize all products resulting from the collaboration. Research Leveraging its unique target selection strategy, proven small molecule discovery capabilities, and deep development expertise, the Company intends to advance at least one new development candidate towards IND for a first-in-class, oral program in 2026.Corporate The Company appointed Neil Graham, MBBS, MD, MPH, as Chief Development Officer to lead the advancement of Kymera’s oral immunology portfolio. Dr. Graham brings more than 30 years of global biopharma leadership experience, having advanced antiviral and immunology programs from early research through regulatory approval and commercial launch. Throughout his career, Dr. Graham has contributed to several therapeutic advances, including the development of dupilumab at Regeneron, the first protease inhibitor for hepatitis C at Vertex,