KT-621 (STAT6) parallel Phase 2b trials, BROADEN2 in atopic dermatitis and BREADTH in asthma, ongoing with data expected by mid-2027 and late 2027, respectively
FDA granted Fast Track designation to KT-621 for the treatment of moderate to severe asthma, in addition to prior Fast Track designation for moderate to severe atopic dermatitis
KT-579 (IRF5) Phase 1 healthy volunteer trial ongoing, with data expected in 2H26
Gilead Sciences exercised its option to exclusively license KT-200, a first-in-class, oral CDK2 molecular glue degrader, generating a
Well-capitalized with
Company to hold video conference call and webcast today at
“As we continue to advance KT-621 and KT-579 through clinical development, our focus remains on disciplined execution and delivering on multiple important milestones this year,” 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. KT-621 is 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 AD 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. - In the first quarter of 2026, the Company completed the KT-621 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 toxicology studies.
- In
March 2026 , the Company presented positive results from the KT-621 BroADen Phase 1b AD clinical trial in a late-breaking oral presentation at theAmerican Academy of Dermatology (AAD) Annual Meeting. The data demonstrated deep STAT6 degradation, reductions in Type 2 inflammatory biomarkers, encouraging clinical activity, and a favorable safety profile, supporting STAT6 degradation as a novel oral approach for Type 2 inflammatory diseases. - In
April 2026 , theU.S. Food and Drug Administration granted Fast Track designation to KT-621 for the treatment of moderate to severe eosinophilic asthma. - In
May 2026 , the Company will present on KT-621 at multiple medical meetings, including a late-breaking oral presentation at theSociety of Investigative Dermatology (SID) Annual Meeting highlighting STAT6 degradation and modulation of Th2 gene transcripts in AD lesional skin. Additionally, the Company will have a featured oral presentation at theAmerican Thoracic Society (ATS) Annual Meeting Respiratory Innovation Summit focused on the potential of KT-621 to transform treatment paradigms in respiratory care.
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 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 , after IND-clearance from the FDA, the Company 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, pro-inflammatory cytokines, and inflammatory pathway gene transcripts 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. - Building on KT-579’s preclinical profile, the Company plans to present new data further characterizing its activity across autoimmune disease models, including IBD at Digestive Disease Week (DDW) in May, as well as lupus at the
European Alliance of Associations for Rheumatology (EULAR) Congress and the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, both in June.
Partnered Programs
- In
April 2026 , the Company announced that Gilead Sciences exercised its option to exclusively license KT-200, a first-in-class, oral CDK2 molecular glue degrader development candidate discovered and characterized by Kymera. As a result, Kymera achieved a$45 million milestone payment, expected to be received in the second quarter. KT-200 has the potential to deliver meaningful improvements in the standard of care for patients with breast cancer and other solid tumors. Gilead will progress the program into IND-enabling studies to support an IND filing in 2027. - KT-485/
SAR447971 , a selective, potent, oral IRAK4 degrader being advanced in partnership with Sanofi, has the potential to offer a novel oral approach for a variety of chronic immuno-inflammatory diseases. The program has completed IND-enabling studies, with clinical entry expected in 2026.
Research
- Leveraging its unique target selection strategy, proven small molecule discovery capabilities, and deep development expertise, the Company expects to advance at least one new development candidate towards IND for a first-in-class, oral program in 2026.
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, the effect of initial parallel development of Phase 2b studies in AD and asthma patients on acceleration of late parallel development across multiple indications, the KT-485/
| Consolidated Balance Sheets | ||||||
| (In thousands, except share and per share amounts) | ||||||
| (Unaudited) | ||||||
2026 | 2025 | |||||
| Assets | ||||||
| Cash, cash equivalents and marketable securities | $ | 1,545,653 | $ | 1,619,434 | ||
| Property and equipment, net | 41,617 | 43,175 | ||||
| Right-of-use assets, operating lease | 41,736 | 42,351 | ||||
| Other assets | 40,010 | 37,852 | ||||
| Total assets | $ | 1,669,016 | $ | 1,742,812 | ||
| Liabilities and Stockholders’ Equity | ||||||
| Deferred revenue | $ | — | $ | 34,365 | ||
| Operating lease liabilities | 77,617 | 78,975 | ||||
| Other liabilities | 51,762 | 49,808 | ||||
| Total liabilities | 129,379 | 163,148 | ||||
| Total stockholders’ equity | 1,539,637 | 1,579,664 | ||||
| Total liabilities and stockholders’ equity | $ | 1,669,016 | $ | 1,742,812 | ||
| Consolidated Statements of Operations | |||||||
| (In thousands, except share and per share amounts) | |||||||
| (Unaudited) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Collaboration Revenue | $ | 34,365 | $ | 22,100 | |||
| Operating expenses: | |||||||
| Research and development | $ | 98,162 | $ | 80,255 | |||
| General and administrative | 20,357 | 16,271 | |||||
| Total operating expenses | 118,519 | 96,526 | |||||
| Loss from operations | (84,154 | ) | (74,426 | ) | |||
| Other income (expense): | |||||||
| Interest and other income | 14,981 | 8,917 | |||||
| Interest and other expense | (61 | ) | (72 | ) | |||
| Total other income | 14,920 | 8,845 | |||||
| Net loss attributable to common stockholders | $ | (69,234 | ) | $ | (65,581 | ) | |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.71 | ) | $ | (0.82 | ) | |
| Weighted average common stocks outstanding, basic and diluted | 97,534,269 | 80,146,531 | |||||
Investor Contact:
investors@kymeratx.com
857-285-5300
Media Contact:
mhenson@kymeratx.com
857-285-5300
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