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-2027
Initiated dosing in KT-579 (IRF5) Phase 1 healthy volunteer trial with data expected in 2H26
Dr.
Well-capitalized with
Company to hold video conference call and webcast today at
“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
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 , theU.S. Food and Drug Administration grantedFast 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 theAmerican 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, and combination anti-HIV therapies at Glaxo Wellcome. Earlier in his career, he was Associate Professor of Infectious Diseases Epidemiology at theJohns Hopkins Bloomberg School of Public Health and School of Medicine . He holds medical and postgraduate degrees from theUniversity of Adelaide . - In
December 2025 , the Company completed a$602 million underwritten equity offering. Total gross proceeds, including the underwriters' subsequent full exercise of the overallotment option, were approximately$692 million . With these proceeds, the Company ended the year datedDecember 31, 2025 , with approximately$1.6 billion in cash and extended its runway into 2029.
Financial Results
Collaboration Revenues: Collaboration revenues were
Research and Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Net Loss: Net loss was
Cash and Cash Equivalents: As of
Event Details
Kymera will host a video conference call today,
About
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and objectives on the development of our clinical and preclinical pipeline, including the therapeutic potential, clinical benefits and safety thereof, including for the Phase 1b data readout of KT-621 in AD patients in
| Consolidated Balance Sheets | ||||||
| (In thousands, except share and per share amounts) | ||||||
| (Unaudited) | ||||||
2025 | 2024 | |||||
| Assets | ||||||
| Cash, cash equivalents and marketable securities | $ | 1,619,434 | $ | 850,903 | ||
| Property and equipment, net | 43,175 | 50,457 | ||||
| Right-of-use assets, operating lease | 42,351 | 47,407 | ||||
| Other assets | 37,852 | 29,268 | ||||
| Total assets | $ | 1,742,812 | $ | 978,035 | ||
| Liabilities and Stockholders’ Equity | ||||||
| Deferred revenue | $ | 34,365 | $ | 13,576 | ||
| Operating lease liabilities | 78,975 | 84,017 | ||||
| Other liabilities | 49,808 | 44,823 | ||||
| Total liabilities | 163,148 | 142,416 | ||||
| Total stockholders’ equity | 1,579,664 | 835,619 | ||||
| Total liabilities, preferred stock and stockholders’ equity | $ | 1,742,812 | $ | 978,035 | ||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Collaboration Revenue | $ | 2,871 | $ | 7,394 | $ | 39,211 | $ | 47,072 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 83,831 | $ | 71,818 | $ | 316,568 | $ | 240,248 | ||||||||
| General and administrative | 16,935 | 16,331 | 68,187 | 63,534 | ||||||||||||
| Impairment of long-lived assets | — | — | 3,855 | 4,925 | ||||||||||||
| Total operating expenses | 100,766 | 88,149 | 388,610 | 308,707 | ||||||||||||
| Loss from operations | (97,895 | ) | (80,755 | ) | (349,399 | ) | (261,635 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 11,006 | 10,061 | 38,418 | 38,026 | ||||||||||||
| Interest and other expense | (92 | ) | (59 | ) | (370 | ) | (249 | ) | ||||||||
| Total other income | 10,914 | 10,002 | 38,048 | 37,777 | ||||||||||||
| Net loss attributable to common stockholders | $ | (86,981 | ) | $ | (70,753 | ) | $ | (311,351 | ) | $ | (223,858 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.97 | ) | $ | (0.88 | ) | $ | (3.69 | ) | $ | (2.98 | ) | ||||
| Weighted average common stocks outstanding, basic and diluted | 89,914,699 | 79,987,426 | 84,490,585 | 75,043,991 | ||||||||||||
Investor Contact:
Vice President, Investor Relations
investors@kymeratx.com
857-285-5300
Media Contact:
Vice President, Corporate Communications
mhenson@kymeratx.com
857-285-5300
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