Enrollment completed in KT-621 (STAT6) BROADEN2 Phase 2b AD trial nearly six months ahead of anticipated timeline, with data expected by year-end 2026
KT-621 Phase 3 trials in AD planned to initiate by mid-2027
KT-621 BREADTH Phase 2b asthma trial ongoing, with data expected to be reported in late 2027
KT-579 (IRF5) Phase 1 healthy volunteer trial ongoing, with data expected in 4Q26
KT-485 (IRAK4) Phase 1 trial commenced in healthy volunteers and HS patients by partner Sanofi
Well-capitalized with
Company to hold video conference call and webcast today at
“Kymera is delivering in a pivotal period of execution, with multiple clinical-stage programs advancing, important data catalysts ahead, and growing conviction in the potential of oral degrader medicines to transform the standard of care for chronic, debilitating immunological diseases,” 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 development in atopic dermatitis (AD) and asthma. KT-621 has the potential to transform treatment for more than 140 million patients around the world suffering from Type 2 diseases such as atopic dermatitis (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
June 2026 , the Company announced the completion of enrollment in the KT-621 BROADEN2 Phase 2b clinical trial in patients with moderate to severe atopic dermatitis nearly six months ahead of its original timeline. The earlier than expected completion of enrollment enabled the Company to accelerate its expected topline data readout by six months to year-end 2026, earlier than prior guidance to share data by mid-2027. Subject to discussions with regulators, the Company expects to initiate Phase 3 trials in AD by mid-2027. - Enrollment is ongoing in the KT-621 BREADTH Phase 2b clinical trial in patients with moderate to severe eosinophilic asthma. The Company expects to report data in late 2027.
- In
June 2026 at theJapanese Dermatological Association (JDA) Annual Meeting, the Company presented results from the KT-621 Phase 1 study in healthy Japanese adults designed to support the enrollment of patients inJapan in global KT-621 studies. KT-621 demonstrated a favorable PK profile, rapid and sustained STAT6 degradation in blood, with median STAT6 degradation of =98% at both dose levels, and a favorable safety and tolerability profile. These results are consistent with those observed in non-Japanese healthy adults and atopic dermatitis patients. - The Company presented data from the KT-621 Phase 1 clinical trials across leading dermatology and respiratory forums, including a late-breaking oral presentation at the
Society for Investigative Dermatology (SID) Annual Meeting, an oral presentation at theAmerican Thoracic Society (ATS) Respiratory Innovation Summit, and poster presentations at theRevolutionizing Atopic Dermatitis (RAD) andAmerican Academy of Dermatology (AAD) Innovation Academy meetings.
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, that is currently in Phase 1 testing. 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), rheumatoid arthritis (RA) and others.
- Enrollment is ongoing in the KT-579 Phase 1 clinical trial in healthy volunteers, with data expected in the fourth quarter of 2026. The Company plans to initiate a Phase 1b patient proof-of-concept trial in lupus soon after the completion of the healthy volunteer trial.
- The Company presented new preclinical data for KT-579 at the
European Alliance of Associations for Rheumatology (EULAR) and Federation of Clinical Immunology Societies (FOCIS) Annual Meetings that demonstrated consistent disease-modifying activity across multiple preclinical lupus models. The Company also presented IBD data at Digestive Disease Week (DDW), where KT-579 demonstrated activity comparable or superior to clinically relevant comparators in a preclinical IBD model.
Partnered Programs
- In
June 2026 , under its existing collaboration, Sanofi initiated the first-in-human Phase 1 clinical trial evaluating KT-485 (SAR447971 ), an oral, potent and selective second generation IRAK4 degrader, in adult healthy volunteers and hidradenitis suppurativa patients. Under the terms of the collaboration, dosing of the first participant resulted in a$20 million milestone payment to Kymera. KT-485 has the potential to offer a novel oral approach for a variety of chronic immuno-inflammatory diseases. Per the collaboration, Sanofi is leading development, regulatory, and commercial efforts for the program. - 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. KT-200 has the potential to deliver meaningful improvements in the standard of care for patients with breast cancer and other solid tumors. Gilead intends to progress the program into IND-enabling studies to support an IND filing in 2027.
Research
- Leveraging its unique target selection strategy, proven small molecule discovery capabilities, and deep development expertise, the Company continues to advance an early pipeline of novel oral programs with a goal to deliver at least one new development candidate per year.
Corporate
- In
June 2026 , the Company announced the appointment ofFelix J. Baker , PhD, as Chairman of the Board of Directors.Dr. Baker succeedsBruce Booth , DPhil, who has served as Chairman since co-founding Kymera in 2016 and will remain an Independent Director. - In
July 2026 , the Company appointedTerence Rooney , MD, as Chief Medical Officer.Dr. Rooney is an accomplished drug development leader with extensive experience advancing immunology therapies across the full development lifecycle, from early clinical stage through commercialization and franchise expansion.Dr. Rooney will lead Kymera’s global clinical development strategy and guide the advancement of the Company’s oral immunology portfolio. He succeedsJared Gollob , MD, who retired from his role after eight years of leadership at the Company and will remain as an advisor through the end of the year. - The Company further strengthened its leadership team with the two important appointments further positioning Kymera to advance its clinical-stage pipeline through its next phase of development and growth.
Penny Carlson joined as Senior Vice President, Development Operations, to oversee global clinical development operations.Elizabeth Laws , PhD, joined as Senior Vice President, Development Program Leader, to lead the strategy and global development of KT-621 and the STAT6 franchise.
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 Therapeutics
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/SAR447971 and KT-200 programs, and Kymera’s financial condition and expected cash runway into 2029. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target," “upcoming” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from any forward-looking statements contained in this press release, including, without limitation, risks associated with: the risk that preclinical and clinical data, including the results from the Phase 1 trials of KT-621, are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidate, uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with and submissions to regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements, the unexpected emergence of adverse events or other undesirable side effects during preclinical and clinical development, and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
| Consolidated Balance Sheets | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
2026 | 2025 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and marketable securities | $ | 1,504,886 | $ | 1,619,434 | ||||
| Accounts Receivable | 20,000 | — | ||||||
| Property and equipment, net | 39,971 | 43,175 | ||||||
| Right-of-use assets, operating lease | 41,100 | 42,351 | ||||||
| Other assets | 39,487 | 37,852 | ||||||
| Total assets | $ | 1,645,444 | $ | 1,742,812 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Deferred revenue | $ | — | $ | 34,365 | ||||
| Operating lease liabilities | 76,141 | 78,975 | ||||||
| Other liabilities | 60,047 | 49,808 | ||||||
| Total liabilities | 136,188 | 163,148 | ||||||
| Total stockholders’ equity | 1,509,256 | 1,579,664 | ||||||
| Total liabilities, preferred stock and stockholders’ equity | $ | 1,645,444 | $ | 1,742,812 | ||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Collaboration Revenue | $ | 65,000 | $ | 11,476 | $ | 99,365 | $ | 33,576 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 119,481 | $ | 78,388 | $ | 217,644 | $ | 158,643 | ||||||||
| General and administrative | 21,126 | $ | 17,645 | 41,484 | 33,916 | |||||||||||
| Total operating expenses | 140,607 | 96,033 | 259,128 | 192,559 | ||||||||||||
| Loss from operations | (75,607 | ) | (84,557 | ) | (159,763 | ) | (158,983 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 14,477 | 8,051 | 29,459 | 16,968 | ||||||||||||
| Interest and other expense | (81 | ) | (108 | ) | (141 | ) | (180 | ) | ||||||||
| Total other income | 14,396 | 7,943 | 29,318 | 16,788 | ||||||||||||
| Net loss attributable to common stockholders | $ | (61,211 | ) | $ | (76,614 | ) | $ | (130,445 | ) | $ | (142,195 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.62 | ) | $ | (0.95 | ) | $ | (1.33 | ) | $ | (1.77 | ) | ||||
| Weighted average common stocks outstanding, basic and diluted | 98,177,158 | 80,449,405 | 97,857,489 | 80,298,940 | ||||||||||||
Investor Contact:
investors@kymeratx.com
857-285-5300
Media Contact:
media@kymeratx.com
857-285-5300
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