Kymera Therapeutics (KYMR) has upcoming FDA regulatory milestones for KT-474. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Kymera Therapeutics (KYMR).
Over the past two years, Kymera Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KT-579, KT-621, KT-485, KT-474, KT-295, and KT-333. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
KT-579 FDA Regulatory Events
KT-579 is a drug developed by Kymera Therapeutics for the following indication: Oral IRF5 Degrader.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KT-579
- Announced Date:
- May 5, 2026
- Indication:
- Oral IRF5 Degrader
Announcement
Kymera Therapeutics announced the presentation of new preclinical data for KT-579, its potent, selective, oral IRF5 degrader, demonstrating disease-modifying activity in an inflammatory bowel disease (IBD) model.,
AI Summary
Kymera Therapeutics reported new preclinical results for KT-579, a potent, selective, oral degrader of IRF5, a protein that drives inflammatory responses. In laboratory inflammatory bowel disease (IBD) models, KT-579 showed disease‑modifying activity, reducing pathological inflammation and tissue changes that underlie chronic gut disease.
In those preclinical studies, KT-579’s effects were comparable to—or better than—approved and clinically active IBD therapies, suggesting it could offer a different mechanism by targeting IRF5 directly. The data support the idea that degrading IRF5 may change disease course rather than only relieving symptoms.
KT-579 is in a Phase 1 trial with healthy volunteers, and topline data are expected in the second half of 2026. The new preclinical poster was presented at Digestive Disease Week 2026 and is available in Kymera’s Resource Library.Read Announcement
- Drug:
- KT-579
- Announced Date:
- October 27, 2025
- Indication:
- Oral IRF5 Degrader
Announcement
Kymera Therapeutics, announced the presentation of new preclinical data for KT-579, its potent, selective, oral IRF5 degrader, demonstrating disease-modifying activity across multiple immuno-inflammatory diseases.
AI Summary
In October 2025, Kymera Therapeutics presented new preclinical data for KT-579, a potent, selective, oral IRF5 degrader. These studies, shown at the American College of Rheumatology meeting, highlight KT-579’s ability to modify disease processes in models of lupus and rheumatoid arthritis.
By selectively targeting IRF5, a key immune regulator, KT-579 blocked multiple pro-inflammatory pathways. In lupus models, it reduced Type I interferon signaling, lowered interferon-stimulated genes and autoantibodies, and prevented kidney damage. In arthritis models, KT-579 achieved dose-dependent reduction in joint swelling, inhibited pro-inflammatory cytokines and Th1 responses, and protected bone structure. In human cell assays, it also prevented pathogenic T cell differentiation by blocking Th1-skewing signals.
These findings underline KT-579’s multifaceted mechanism and its promise as an oral therapy for IRF5-driven disorders. Kymera plans to start Phase 1 testing of KT-579 in early 2026.
Read Announcement- Drug:
- KT-579
- Announced Date:
- October 27, 2025
- Indication:
- Oral IRF5 Degrader
Announcement
Kymera Therapeutics, announced that KT-579 Phase 1 testing expected to begin in early 2026
AI Summary
Kymera Therapeutics has reported promising preclinical results for KT-579, a potent and selective oral degrader of IRF5, a key regulator of immune responses. In laboratory studies, KT-579 showed strong activity in models of lupus and rheumatoid arthritis (RA), matching or outperforming current approved therapies. By targeting and degrading IRF5, the compound suppressed multiple pro-inflammatory pathways linked to these autoimmune diseases.
In lupus mouse models, KT-579 reduced type I interferon signaling, lowered disease-related autoantibodies, and protected kidneys from damage. In rodent RA models, it achieved dose-dependent reductions in joint swelling and inhibited pro-inflammatory cytokines, helping to prevent bone destruction. Additional in vitro tests confirmed that KT-579 can block harmful immune cell signals.
Encouraged by these results, Kymera plans to begin Phase 1 clinical testing of KT-579 in early 2026. If successful, this oral degrader could offer a new treatment option for patients with complex rheumatic and autoimmune conditions.
Read Announcement
KT-621 FDA Regulatory Timeline and Events
KT-621 is a drug developed by Kymera Therapeutics for the following indication: A potential oral treatment for asthma and other TH2 respiratory diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KT-621
- Announced Date:
- April 13, 2026
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-621, its first-in-class oral STAT6 degrader, for the treatment of moderate to severe eosinophilic asthma.
AI Summary
Kymera Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to KT-621, its first-in-class oral STAT6 degrader, for the treatment of moderate to severe eosinophilic asthma. KT-621 is designed to target and break down STAT6, a protein that drives type 2 immune responses and eosinophilic inflammation linked to asthma symptoms. As an oral therapy, it could offer a new, non-injectable option for patients with this form of asthma.
Fast Track status is given to drugs that address unmet medical needs for serious conditions and can speed development and review. The designation may allow Kymera to communicate more frequently with the FDA and pursue rolling review of data. Kymera’s ongoing KT-621 BREADTH Phase 2b asthma trial is continuing, with topline data expected in late 2027, which will help determine the drug’s safety and effectiveness for this patient group.
Read Announcement- Drug:
- KT-621
- Announced Date:
- March 28, 2026
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, Inc announced that the positive results from the BroADen Phase 1b atopic dermatitis (AD) clinical trial of KT-621, its first-in-class, oral STAT6 degrader, were featured in a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting. The meeting is being held March 27-31, 2026, in Denver, CO.
AI Summary
Kymera Therapeutics announced that positive results from the BroADen Phase 1b atopic dermatitis (AD) clinical trial of KT-621, its first-in-class oral STAT6 degrader, were presented as a late‑breaking oral presentation at the American Academy of Dermatology Annual Meeting (March 27–31, 2026, Denver). The company said the data support KT-621’s compelling oral profile for treating AD and were highlighted during the AAD scientific program.
Kymera noted parallel Phase 2b trials — BROADEN2 in atopic dermatitis and BREADTH in asthma — are ongoing, with topline data expected by mid‑2027 and late‑2027, respectively. A copy of the AAD presentation will be posted in Kymera’s Resource Library after the session, and the company will staff booth #3551 in the exhibit hall.
The late‑breaking designation underscores strong scientific interest in KT-621 as a potential oral treatment option; Dr. Emma Guttman‑Yassky is listed as a paid consultant for Kymera.
Read Announcement- Drug:
- KT-621
- Announced Date:
- March 10, 2026
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
- Kymera Therapeutics, Inc announced that data from its KT-621 BroADen Phase 1b clinical trial in patients with atopic dermatitis will be presented in a late-breaking oral session at the American Academy of Dermatology (AAD) 2026 Annual Meeting.
AI Summary
Kymera Therapeutics announced that data from its KT-621 BroADen Phase 1b trial in patients with moderate-to-severe atopic dermatitis will be presented in a late-breaking oral session at the American Academy of Dermatology (AAD) 2026 Annual Meeting. KT-621 is an oral STAT6 degrader being developed to treat chronic immuno-inflammatory diseases. Jared Gollob, MD, Kymera’s Chief Medical Officer, said the company is honored the data were selected and looks forward to sharing findings and engaging with the dermatology community.
The late-breaking oral presentation, titled “Clinical Activity and Safety of KT-621, an Oral STAT6 Degrader, in Moderate-to-Severe Atopic Dermatitis: Phase 1b Trial Results,” is scheduled for Saturday, March 28, 2026 at 9:24 AM MT in Bellco Theatre. A copy of the presentation will be posted in Kymera’s Resource Library on its website after the session.
Read Announcement- Drug:
- KT-621
- Announced Date:
- January 29, 2026
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that it recently initiated dosing in its BREADTH Phase 2b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe eosinophilic asthma. The Company expects to report data from the BREADTH trial in late-2027.
AI Summary
Kymera Therapeutics has begun dosing patients in its BREADTH Phase 2b trial of KT-621, an oral, highly selective and potent degrader of STAT6. The study is enrolling people with moderate to severe eosinophilic asthma to test whether KT-621 can reduce inflammation and improve breathing by targeting the STAT6 pathway. The drug’s oral form could offer a convenient alternative to existing treatments if it proves effective and safe.
Kymera plans to report topline data from the BREADTH trial in late 2027. The company is also running a parallel BROADEN2 Phase 2b trial in atopic dermatitis, with data expected by mid-2027, which may provide additional information on KT-621’s activity across related inflammatory conditions. These readouts will help determine next steps for development and potential broader use of the therapy.
Read Announcement- Drug:
- KT-621
- Announced Date:
- January 13, 2026
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced its anticipated 2026 preclinical and clinical milestones across its industry leading oral immunology pipeline.
AI Summary
Kymera Therapeutics outlined its 2026 preclinical and clinical milestones for an oral immunology pipeline built on targeted protein degraders. Lead program KT-621, a once-daily oral STAT6 degrader for Type 2 inflammation, is in Phase 2 testing: the BROADEN2 Phase 2b trial in moderate-to-severe atopic dermatitis is ongoing with data expected by mid-2027, and the BREADTH Phase 2b trial in eosinophilic asthma was initiated with data expected in late-2027. Both are randomized, placebo-controlled dose-ranging studies focused on clinical efficacy and safety.
Kymera also plans to start a first-in-human healthy volunteer Phase 1 trial of KT-579, an oral IRF5 degrader, in Q1 2026 with data anticipated in the second half of 2026. The company intends to advance at least one new development candidate toward IND in 2026, remains well-capitalized with about $1.6 billion in cash (runway into 2029), and will present its 2026 objectives at the J.P. Morgan Healthcare Conference.
Read Announcement- Drug:
- KT-621
- Announced Date:
- December 11, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-621, its first-in-class, oral STAT6 degrader, for the treatment of moderate to severe atopic dermatitis (AD).,
AI Summary
Kymera Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to KT-621, its first-in-class, once-daily oral STAT6 degrader, for the treatment of moderate to severe atopic dermatitis (AD). Fast Track status can help speed development and review by enabling more frequent interactions with the FDA and potentially accelerating approval if criteria are met.
The designation was supported by positive BroADen Phase 1b results showing deep STAT6 degradation in blood and skin, strong reductions in Type 2 inflammatory biomarkers, meaningful clinical improvements in AD and benefits for comorbid asthma and allergic rhinitis, along with a favorable safety profile. Kymera aims for KT-621 to deliver the effectiveness and safety of injectable biologics in an oral form to broaden patient access.
The BROADEN2 Phase 2b trial in moderate to severe AD is ongoing with data expected by mid-2027, and the BREADTH Phase 2b asthma trial is planned to start in the first quarter of 2026. These studies will guide dose selection and further development across Type 2 diseases.
Read Announcement- Drug:
- KT-621
- Announced Date:
- December 8, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced positive clinical results from the BroADen Phase 1b atopic dermatitis (AD) clinical trial of KT-621, its first-in-class, oral STAT6 degrader medicine.
AI Summary
Kymera reported positive Phase 1b BroADen results for KT-621, an oral STAT6 degrader, in 22 patients with moderate‑to‑severe atopic dermatitis. At 100 mg and 200 mg once daily, KT-621 achieved deep STAT6 degradation—median 98% in blood and 94% in skin—showing strong translation from healthy volunteers to AD patients.
KT-621 produced large drops in Type 2 biomarkers, including a 74% median TARC reduction in patients with baseline levels comparable to dupilumab studies, strong decreases in Eotaxin‑3 and IL‑31 (~54–56%), and modest IgE declines. FeNO, a lung inflammation marker, fell 25–33% overall and 56% in patients with comorbid asthma.
Clinically, the drug drove a mean 63% EASI reduction and a mean 40% decrease in peak itch, with improvements in SCORAD, DLQI and POEM. Patients with allergic rhinitis and asthma also reported meaningful symptom and quality‑of‑life benefits.
KT-621 was well tolerated with no serious or treatment‑related adverse events reported. BROADEN2 Phase 2b in AD is ongoing (data expected mid‑2027) and a Phase 2b asthma trial is planned to start in early 2026.
Read Announcement- Drug:
- KT-621
- Announced Date:
- December 5, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announce results from the BroADen Phase 1b clinical trial evaluating KT-621, its oral STAT6 degrader, in patients with moderate to severe atopic dermatitis (AD) on Monday, December 8, 2025.
AI Summary
Kymera Therapeutics will announce results from the BroADen Phase 1b clinical trial of KT-621, its oral STAT6 degrader for patients with moderate to severe atopic dermatitis, on Monday, December 8, 2025. The company will release a press statement at 7:00 a.m. ET, followed by a video conference call and webcast at 8:00 a.m. ET. Interested parties can register on Kymera’s Investors website, and a replay and presentation will be posted after the event.
KT-621 is a first-in-class, once-daily oral degrader of STAT6, the transcription factor that drives IL-4/IL-13 signaling and Type 2 inflammation. In a Phase 1 study in healthy volunteers, KT-621 showed complete STAT6 degradation in blood and skin at low doses, reduced several Type 2 biomarkers, and had a safety profile similar to placebo. BroADen Phase 1b results will inform further development; Kymera’s BROADEN2 Phase 2b trial in moderate to severe AD is ongoing with data expected by mid-2027.
Read Announcement- Drug:
- KT-621
- Announced Date:
- November 25, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
- Kymera Therapeutics, announced that it recently initiated dosing in its BROADEN2 Phase 2b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD).
AI Summary
Kymera Therapeutics has started dosing in BROADEN2, a Phase 2b trial testing KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD). KT-621 is a first‑in‑industry STAT6 degrader aimed at blocking the IL‑4/IL‑13 signaling that drives Type 2 inflammation. The company expects to report BROADEN2 data by mid‑2027.
BROADEN2 is a randomized, double‑blind, placebo‑controlled, multicenter, dose‑ranging study of about 200 patients treated for 16 weeks. Eligible patients must have EASI ≥16, at least 10% body surface area affected, and an average weekly Pruritus NRS ≥4. The primary endpoint is percent change from baseline in EASI at Week 16. Secondary measures include EASI‑50/EASI‑75, a validated Investigator Global Assessment (vIGA) score of 0–1, and at least a 4‑point improvement in Peak Pruritus NRS. Participants may join a 52‑week open‑label extension to assess longer‑term safety and efficacy.
Read Announcement- Drug:
- KT-621
- Announced Date:
- November 4, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics Provides a Business Update
AI Summary
Kymera Therapeutics provided a business update on its oral small molecule degrader programs. The company completed enrollment and dosing in the KT-621 BroADen Phase 1b trial in 20 patients with moderate-to-severe atopic dermatitis. These results will be reported in December 2025.
Kymera initiated the KT-621 BROADEN2 Phase 2b trial in AD and expects initial data by mid-2027. It plans to start the BREADTH Phase 2b asthma study in early 2026. These parallel trials will speed KT-621 development across multiple indications.
In its IRF5 degrader program, IND-enabling studies for KT-579 are complete and a Phase 1 clinical trial is planned for early 2026. KT-579 targets inflammation drivers in autoimmune diseases.
With $979 million in cash as of September 30, 2025, Kymera expects funding to support operations into late 2028. The company will host a video conference call and webcast today at 8:30 a.m. ET.
Read Announcement- Drug:
- KT-621
- Announced Date:
- September 17, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics announced that the positive results from the Phase 1 healthy volunteer clinical trial of KT-621, its first-in-class, oral STAT6 degrader, will be featured in two separate late-breaking oral presentations at the European Academy of Dermatology & Venereology (EADV) Congress being held September 17-20, in Paris, France, and at the European Respiratory Society (ERS) Congress being held September 27-October 1, in Amsterdam, Netherlands. Additionally, the Company will share new preclinical data in an EADV poster that builds upon KT-621's compelling characterization in disease-relevant contexts compared to dupilumab.,
AI Summary
Kymera Therapeutics announced that positive results from its Phase 1 healthy volunteer trial of KT-621 will be highlighted in two late-breaking oral presentations. One presentation will be at the European Academy of Dermatology & Venereology (EADV) Congress in Paris, September 17–20, and the other at the European Respiratory Society (ERS) Congress in Amsterdam, September 27–October 1.
The company will also share new preclinical data in an EADV poster. These findings build on KT-621’s strong characterization in disease-relevant contexts and directly compare its effects to dupilumab in skin and blood models, reinforcing its potential to match the biologic’s activity.
KT-621 is a first-in-class, once-daily oral STAT6 degrader designed to mimic upstream biologics like dupilumab while offering pill-based convenience. The robust STAT6 degradation and pathway engagement observed support its promise as a novel systemic therapy for Th2-driven conditions such as atopic dermatitis and asthma.
Read Announcement- Drug:
- KT-621
- Announced Date:
- June 2, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced positive clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class, oral STAT6 degrader medicine.
AI Summary
Kymera Therapeutics recently reported very positive Phase 1 results from its study of KT-621, a first-in-class, once-daily oral STAT6 degrader. The study performed on healthy volunteers showed that KT-621 achieved more than 90% STAT6 degradation in blood at doses above 1.5 mg, and complete STAT6 degradation in both blood and skin at doses of 50 mg and higher. This outcome demonstrates the drug’s strong potency and supports its ability to work like injectable biologics while being conveniently taken by mouth.
The trial also measured effects on Th2 biomarkers, with reductions in TARC and Eotaxin-3 that were in line with or even better than results seen with current treatments like dupilumab. Importantly, KT-621 was well tolerated, with a safety profile similar to placebo and no significant adverse events, offering promising potential for treating allergic diseases driven by IL-4/IL-13 signaling.
Read Announcement- Drug:
- KT-621
- Announced Date:
- May 30, 2025
- Target Action Date:
- June 2, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announce results from the Phase 1 clinical trial evaluating single and multiple-ascending doses of KT-621 in healthy volunteers on Monday, June 2, 2025.
AI Summary
Kymera Therapeutics, a clinical-stage biopharmaceutical company, will announce results from its Phase 1 clinical trial of KT-621 on Monday, June 2, 2025. The study evaluated both single and multiple-ascending doses of KT-621 in healthy volunteers to understand the safety and effects of this new oral drug.
KT-621 is designed to degrade STAT6, a protein involved in driving inflammation in various immune conditions. By targeting STAT6, this first-in-class oral medicine could provide benefits similar to injectable biologics, potentially offering a more convenient treatment option for patients with disorders like atopic dermatitis and asthma.
The company will present the trial results during a video webcast at 8:00 a.m. ET, with a replay and detailed presentation available afterward, marking an important step forward in oral therapies for immunological diseases.
Read Announcement- Drug:
- KT-621
- Announced Date:
- May 19, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics,announced the presentation of additional preclinical data for KT-621, its potent, selective, oral STAT6 degrader and the first STAT6 targeted medicine to enter clinical development.
AI Summary
Kymera Therapeutics announced new preclinical data for KT-621, its potent, selective, oral STAT6 degrader and the first STAT6 targeted medicine in clinical development. The data, presented at the ATS conference, showed that KT-621 not only prevented disease progression but also reversed established Th2 inflammation in a chronic asthma mouse model. The results suggested that KT-621 achieved effects comparable to or even better than dupilumab, a leading injectable biologic, offering the convenience of a once-daily oral treatment.
By targeting STAT6—the key factor driving allergic responses—KT-621 could improve treatment for multiple Th2 diseases like asthma and atopic dermatitis. This promising preclinical evidence supports further clinical studies, including Phase 1 trials in healthy volunteers and patients, with additional trial phases planned later in 2025 and early 2026.
Read Announcement- Drug:
- KT-621
- Announced Date:
- April 22, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that it expects to report data from the BroADen trial in the fourth quarter of 2025.
AI Summary
Kymera Therapeutics recently announced that it expects to report data from its BroADen Phase 1b trial in the fourth quarter of 2025. The trial focuses on KT-621, an oral drug designed to target STAT6, which plays a key role in driving inflammation in patients with moderate to severe atopic dermatitis. The study will assess the drug’s safety, tolerability, and clinical effects by measuring its ability to reduce inflammation markers and improve skin condition over a 28-day treatment period. This advancement is seen as an important step toward providing a convenient and effective treatment for atopic dermatitis. Further updates and detailed results are anticipated later in the year as Kymera continues its development of oral small molecule degrader medicines aimed at addressing significant unmet needs in immuno-inflammatory diseases.
Read Announcement- Drug:
- KT-621
- Announced Date:
- April 22, 2025
- Target Action Date:
- June 1, 2025
- Estimated Target Date Range:
- June 1, 2025 - June 30, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that Completed SAD/MAD dosing in KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025
AI Summary
Kymera Therapeutics announced that it has successfully completed both single ascending dose (SAD) and multiple ascending dose (MAD) dosing in its Phase 1 healthy volunteer trial for KT-621. The trial involved once-daily oral dosing and full follow-up, with detailed data expected to be reported in June 2025. This milestone is a key step in the clinical development of KT-621, an oral, highly selective degrader of STAT6, aimed at offering a convenient treatment option for complex immuno-inflammatory diseases.
Alongside this achievement, the company is advancing its pipeline with a Phase 1b trial in atopic dermatitis patients, scheduled to report data in the fourth quarter of 2025, and plans for Phase 2b trials targeting AD and asthma in the near future. These efforts underscore Kymera’s commitment to transforming treatment paradigms with innovative oral medicines.
Read Announcement- Drug:
- KT-621
- Announced Date:
- April 22, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively
AI Summary
Kymera Therapeutics has announced plans to start two parallel Phase 2b clinical trials to further evaluate its investigational oral therapy, KT-621. One trial will involve patients with atopic dermatitis (AD) and is scheduled to begin in the fourth quarter of 2025, while the other, targeting asthma patients, is expected to start in the first quarter of 2026.
KT-621 works by degrading STAT6, a transcription factor that plays a crucial role in the IL-4/IL-13 signaling pathway responsible for Th2-driven inflammation. By offering a convenient oral option, KT-621 could provide an alternative to injectable biologics. The upcoming trials will assess the drug’s safety, efficacy, and optimal dosing as Kymera prepares for future Phase 3 studies.
Read Announcement - Drug:
- KT-621
- Announced Date:
- April 22, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that it recently initiated dosing in its BroADen Phase 1b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD).
AI Summary
Kymera Therapeutics has recently begun dosing patients with moderate to severe atopic dermatitis (AD) in its BroADen Phase 1b clinical trial. The trial is evaluating KT‑621, an oral, highly selective, and potent degrader of STAT6—a key transcription factor involved in driving the inflammatory response seen in AD. Approximately 20 adult patients will receive KT‑621 once daily for 28 days, while the study assesses the drug’s safety, tolerability, pharmacokinetics, pharmacodynamics, and its impact on clinical endpoints such as skin lesion improvements and itch reduction.
The data from this Phase 1b trial is expected to be reported in the fourth quarter of 2025. The trial’s outcomes will help determine if KT‑621 can effectively reduce STAT6 levels in blood and skin, potentially offering a new, convenient oral treatment option that rivals the effectiveness of existing biologic therapies for AD.
Read Announcement- Drug:
- KT-621
- Announced Date:
- February 27, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, provided business highlights and updates on its pipeline.
AI Summary
Kymera Therapeutics recently provided business highlights and pipeline updates during a company webcast. The clinical-stage biopharmaceutical is advancing its portfolio of oral degraders to treat immunological diseases. Its STAT6 degrader, KT-621, is in a Phase 1 study with healthy volunteers, and the company expects to share complete single- and multiple-dose data in June 2025. A Phase 1b trial in atopic dermatitis patients is set to begin in the second quarter of 2025 with results expected in the fourth quarter, followed by Phase 2b trials in AD and asthma starting later in 2025 and early 2026.
Additionally, Kymera is preparing to launch a Phase 1 trial for its TYK2 degrader, KT-295, with healthy volunteer data anticipated by year-end. The company also announced plans to introduce a new oral degrader program for a high‐value immunology target in early May 2025.
Read Announcement - Drug:
- KT-621
- Announced Date:
- January 14, 2025
- Target Action Date:
- Q2 2025
- Estimated Target Date Range:
- April 1, 2025 - June 30, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics KT-621 (STAT6) Phase 1 healthy volunteer trial ongoing, with data expected in 2Q25
AI Summary
Kymera Therapeutics is advancing its first-in-class STAT6 degrader, KT-621, in a Phase 1 healthy volunteer trial. The drug is designed to block STAT6, a key protein involved in Th2 inflammation, offering a potential new oral treatment option for several inflammatory conditions. Data from the Phase 1 study is expected in the second quarter of 2025.
Building on this progress, Kymera plans to start a Phase 1b trial in atopic dermatitis patients in 2Q25, with clinical data anticipated by the fourth quarter of 2025. Furthermore, the company intends to initiate a Phase 2b trial for atopic dermatitis later in 2025 and another for asthma in early 2026. This timeline signals important upcoming milestones as Kymera continues to develop its innovative oral immunology treatments.
Read Announcement- Drug:
- KT-621
- Announced Date:
- January 14, 2025
- Target Action Date:
- Q2 2025
- Estimated Target Date Range:
- April 1, 2025 - June 30, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics announce plans to initiate a KT-621 Phase 1b trial in atopic dermatitis (AD) patients in 2Q25
AI Summary
Kymera Therapeutics has announced plans to advance its development of KT-621, an oral STAT6 degrader, by initiating a Phase 1b clinical trial in atopic dermatitis (AD) patients in the second quarter of 2025. This follows the ongoing Phase 1 healthy volunteer trial, with data expected in 2Q25, which builds on promising early safety results. The upcoming Phase 1b trial will be pivotal in assessing the safety and initial efficacy of KT-621 specifically in AD patients and is expected to deliver data by the fourth quarter of 2025.
The company aims to use KT-621 to target the IL-4/IL-13 signaling pathway, which is a key driver in AD and other Th2-mediated diseases. This step is an important part of Kymera’s broader strategy to demonstrate that oral drugs can achieve biologics-like activity in treating inflammatory diseases.
Read Announcement- Drug:
- KT-621
- Announced Date:
- January 14, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics announced that data expected in 4Q25
AI Summary
Kymera Therapeutics announced significant progress on its KT-621 program, a first-in-class oral STAT6 degrader aimed at treating inflammatory diseases. The company is currently completing its Phase 1 clinical trial in healthy volunteers, having tested multiple single and multiple dose levels. Looking ahead, Kymera plans to expand KT-621 testing by initiating a Phase 1b trial in atopic dermatitis patients in the second quarter of 2025. Importantly, data from this Phase 1b trial is expected in the fourth quarter of 2025. This milestone, along with plans to launch a Phase 2b trial in atopic dermatitis later in 2025 and another in asthma in early 2026, is a key part of Kymera’s strategy to develop oral drugs that mimic the efficacy of biologics. These efforts underline the company’s commitment to addressing unmet needs in the treatment of Th2 inflammatory diseases.
Read Announcement- Drug:
- KT-621
- Announced Date:
- January 14, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced its corporate goals for 2025, including anticipated progress on its clinical pipeline of immunology programs.
AI Summary
Kymera Therapeutics has revealed its 2025 corporate goals, focusing on significant advances in its immunology pipeline. The company is driving forward its first-in-class oral degrader programs, especially for STAT6 and TYK2 targets. Its STAT6 degrader, KT-621, is progressing well—currently in a Phase 1 trial with healthy volunteers, and data is expected in the second quarter of 2025. Kymera plans to start a Phase 1b trial for KT-621 in atopic dermatitis patients in 2Q25, with results anticipated in the fourth quarter, followed by Phase 2b trials in atopic dermatitis and asthma late in 2025 and early in 2026. These steps underline the company’s commitment to transforming treatment options for inflammatory diseases. Additionally, Kymera’s plans include progress with TYK2 and IRAK4 programs, as well as the upcoming disclosure of a novel immunology candidate in the first half of 2025.
Read Announcement- Drug:
- KT-621
- Announced Date:
- January 14, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera plans to initiate Phase 2b trials in AD and asthma in late 2025 and early 2026, respectively
AI Summary
Kymera Therapeutics is advancing its clinical development plans for its novel STAT6 degrader, KT-621. The company plans to move forward with Phase 2b clinical trials in atopic dermatitis (AD) in late 2025 and in asthma in early 2026. Alongside this, Kymera intends to start a Phase 1b trial for AD patients in the second quarter of 2025, with data expected by the fourth quarter of that year. These studies are part of Kymera’s broader goal to deliver innovative oral treatments that provide biologics-like efficacy for inflammatory diseases. By targeting key proteins involved in Th2 inflammation, the company aims to address significant unmet needs in conditions such as AD and asthma. Kymera’s clinical timeline reflects its commitment to transforming treatment options and expanding its pipeline in the field of immunology.
Read Announcement- Drug:
- KT-621
- Announced Date:
- October 9, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that KT-621 is expected to start Phase 1 in October, with Phase 1 data in the first half of 2025
AI Summary
Kymera Therapeutics has announced that its investigational drug KT-621 is set to begin a Phase 1 clinical trial in October. The trial will involve healthy volunteers as the company tests single and multiple ascending doses against a placebo. The study aims to evaluate the drug’s safety, tolerability, pharmacokinetics, and pharmacodynamics.
KT-621 is an oral STAT6 degrader that shows dupilumab-like effects in preclinical studies. The drug is designed to potentially block the IL-4/IL-13 signaling pathways, which are involved in allergic reactions. Kymera expects to share data from this early trial in the first half of 2025. This milestone marks a promising step in developing a new class of small molecule medicines that could transform the treatment of atopic and allergic diseases.
Read Announcement- Drug:
- KT-621
- Announced Date:
- October 9, 2024
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced the clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for KT-621, a potent, selective, oral degrader of STAT6.
AI Summary
Kymera Therapeutics has achieved an important milestone with the U.S. FDA clearing its Investigational New Drug (IND) application for KT-621. This new drug is an oral degrader of STAT6, a key protein involved in the development of allergic diseases, and it shows activity similar to dupilumab. In preclinical studies, KT-621 demonstrated strong performance and was well tolerated across various models of TH2-driven diseases. The clearance now paves the way for the company to start a Phase 1 clinical trial, with dosing in healthy volunteers scheduled for October 2024. Kymera expects to share initial data from the study by the first half of 2025. The company believes that KT-621 could offer the benefits of a complete pathway blockade with the convenience of an oral medication, potentially changing how allergic and atopic diseases are treated.
Read Announcement- Drug:
- KT-621
- Announced Date:
- September 25, 2024
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 2024
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that KT-621 expected to start Phase 1 in the second half of 2024
AI Summary
Kymera Therapeutics recently announced promising preclinical data for its new drug candidate, KT-621. This oral small molecule works by degrading STAT6, a key factor in TH2-driven inflammation that plays a role in allergic and atopic diseases such as atopic dermatitis. KT-621 has shown the ability to block IL-13-induced signals that lead to itch and pain, offering potential relief for patients. Unlike dupilumab, which is an injectable treatment, KT-621 aims to provide similar therapeutic benefits with the ease of a once-daily pill. The company plans to start Phase 1 clinical testing in the second half of 2024, expecting to report initial trial data in the first half of 2025. This new approach could give patients a more convenient treatment option and broaden access to therapies for chronic allergic conditions.
Read Announcement- Drug:
- KT-621
- Announced Date:
- September 25, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced that with Phase 1 data in the first half of 2025
AI Summary
Kymera Therapeutics, a clinical-stage biopharmaceutical company, recently announced promising preclinical data for KT-621, an oral small molecule designed to degrade STAT6. The data indicates that KT-621 could block IL-4/IL-13 signaling pathways, offering effects similar to dupilumab for allergic and atopic conditions such as atopic dermatitis.
The company has completed the necessary IND-enabling studies and plans to begin Phase 1 clinical testing in the second half of 2024. Kymera expects to report Phase 1 trial data in the first half of 2025. This development highlights KT-621’s potential to provide a convenient, once-daily treatment option for patients suffering from TH2-driven allergic and atopic diseases.
Read Announcement- Drug:
- KT-621
- Announced Date:
- September 25, 2024
- Indication:
- A potential oral treatment for asthma and other TH2 respiratory diseases.
Announcement
Kymera Therapeutics, announced the presentation of preclinical data for KT-621, a potent, selective, oral degrader of STAT6, an essential transcription factor that is a central driver of TH2 inflammation.
AI Summary
Kymera Therapeutics recently presented preclinical data for KT-621, a potent, selective, oral degrader of STAT6, at the European Academy of Dermatology and Venereology Congress. STAT6 is a key transcription factor driving TH2 inflammation, which is involved in allergic and atopic conditions. The data showed that KT-621 effectively degraded STAT6 in human sensory neurons, leading to the inhibition of IL-13-induced gene transcripts that are related to itch and pain. This suggests that KT-621 could help relieve symptoms for atopic dermatitis patients.
The research highlights KT-621’s potential to provide a dupilumab-like effect using an everyday oral small molecule. With strong degradation of STAT6 observed in preclinical studies, KT-621 may offer a convenient once-daily treatment option for TH2-driven diseases. Kymera plans to begin Phase 1 trials in the latter half of 2024, with initial trial data expected in early 2025.
Read Announcement
KT-485 FDA Regulatory Events
KT-485 is a drug developed by Kymera Therapeutics for the following indication: For immunological diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KT-485
- Announced Date:
- June 25, 2025
- Indication:
- For immunological diseases
Announcement
Kymera Therapeutics, announced an update to its IRAK4 partnership with Sanofi.
AI Summary
Kymera Therapeutics announced an update to its IRAK4 partnership with Sanofi. The companies have decided to advance KT-485, a next-generation oral IRAK4 degrader, into Phase 1 clinical studies next year. Preclinical tests showed that KT-485 is more potent and selective, with a better overall safety profile compared to the earlier candidate KT-474, which Sanofi will no longer advance. This decision highlights the strong potential shown by KT-485 in early testing and both companies’ commitment to targeting the IRAK4 pathway. As part of their collaboration, Kymera is eligible to earn up to $975 million in milestones based on further clinical, regulatory, and commercial achievements. The focus on KT-485 reflects Sanofi’s and Kymera’s shared belief in transforming immunology treatment options and improving therapies for patients with immuno-inflammatory diseases.
Read Announcement
KT-474 FDA Regulatory Timeline and Events
KT-474 is a drug developed by Kymera Therapeutics for the following indication: Hidradenitis Suppurativa or Atopic Dermatitis (AD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KT-474
- Announced Date:
- January 14, 2025
- Target Action Date:
- H1 2026
- Estimated Target Date Range:
- January 1, 2026 - June 30, 2026
- Indication:
- Hidradenitis Suppurativa or Atopic Dermatitis (AD)
Announcement
Kymera Therapeutics announced that KT-474/SAR444656 (IRAK4) Phase 2b dose-ranging studies in hidradenitis suppurativa (HS) and AD ongoing, with completion expected in 1H26 and mid-2026, respectively
AI Summary
Kymera Therapeutics announced ongoing Phase 2b dose-ranging studies of its KT-474/SAR444656 (IRAK4) program in patients with hidradenitis suppurativa (HS) and atopic dermatitis (AD). This program is part of Kymera’s approach to developing oral small molecule degrader medicines that offer biologics-like activity for immunological diseases. The studies are being conducted in collaboration with Sanofi, aiming to evaluate the drug’s effectiveness in blocking key inflammatory pathways involved in these conditions.
The study for HS is expected to be completed in the first half of 2026, while the AD trial should conclude by mid-2026. These trials are a critical step for the company as it expands its portfolio in inflammatory diseases. Kymera’s progress with KT-474 demonstrates its commitment to addressing unmet medical needs through novel treatment approaches.
Read Announcement- Drug:
- KT-474
- Announced Date:
- July 8, 2024
- Indication:
- Hidradenitis Suppurativa or Atopic Dermatitis (AD)
Announcement
Kymera Therapeutics, announced that following a review of preliminary KT-474 safety and efficacy data by an Independent Data Review Committee, Sanofi has informed Kymera that it intends to expand the ongoing Hidradenitis Suppurativa (HS) and Atopic Dermatitis (AD) Phase 2 trials to more rapidly progress towards pivotal studies.
AI Summary
Kymera Therapeutics announced that after an Independent Data Review Committee evaluated preliminary safety and efficacy data for its drug KT-474, Sanofi has decided to expand the ongoing Phase 2 trials for Hidradenitis Suppurativa (HS) and Atopic Dermatitis (AD). This decision is made to help the program progress more quickly toward pivotal studies. The move shows that Sanofi has strong confidence in KT-474’s potential to address significant unmet needs in immune-inflammatory conditions.
The expanded trials are planned to speed up clinical development timelines and to support future registrational studies. KT-474 is a first-in-class IRAK4 degrader designed to reduce inflammation by targeting a key protein involved in the immune system. Kymera remains committed to advancing this novel therapy to provide new treatment options for patients with HS, AD, and potentially other immune-inflammatory diseases.
Read Announcement
KT-295 FDA Regulatory Events
KT-295 is a drug developed by Kymera Therapeutics for the following indication: For IBD, psoriasis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KT-295
- Announced Date:
- January 14, 2025
- Target Action Date:
- Q2 2025
- Estimated Target Date Range:
- April 1, 2025 - June 30, 2025
- Indication:
- For IBD, psoriasis
Announcement
Kymera Therapeutics announced that KT-295 (TYK2) to advance into Phase 1 testing in 2Q25
AI Summary
Kymera Therapeutics announced that its KT-295, an investigational TYK2 degrader, is set to move into Phase 1 testing in the second quarter of 2025. This first-in-class, once daily oral drug targets TYK2, a key enzyme in the Janus kinase family involved in inflammatory signaling. Preclinical studies have shown that KT-295 can block the same pathway as some biologic therapies, by mimicking the human genetic loss of function of TYK2.
The company plans to start dosing healthy volunteers in Phase 1, with data expected by the fourth quarter of 2025. This milestone is an important step as Kymera continues to develop innovative oral treatments for inflammatory diseases, including conditions like inflammatory bowel disease and psoriasis. The advancement of KT-295 reflects Kymera's commitment to introducing new treatment options with biologics-like activity in a convenient oral form.
Read Announcement- Drug:
- KT-295
- Announced Date:
- January 14, 2025
- Target Action Date:
- LATE 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- For IBD, psoriasis
Announcement
Kymera Therapeutics announced that data expected in late 2025
AI Summary
Kymera Therapeutics has outlined several important clinical milestones for 2025 in its efforts to develop innovative oral treatments for immune diseases. One key highlight is the advancement of its TYK2 degrader candidate, KT-295, which is planned to enter Phase 1 testing in healthy volunteers in the second quarter of 2025, with data expected later that year. This data readout is eagerly anticipated as it could provide a new oral therapy option that mimics the effects of biologic treatments.
In addition to the TYK2 program, the company is also progressing its STAT6 degrader, KT-621, through multiple trial phases. With a Phase 1 healthy volunteer trial already underway and a planned Phase 1b trial in atopic dermatitis starting in Q2 2025, Kymera is positioning itself to potentially transform treatment approaches for various inflammatory diseases. Further updates are expected to be shared at the upcoming J.P. Morgan Healthcare Conference.
Read Announcement
KT-333 FDA Regulatory Events
KT-333 is a drug developed by Kymera Therapeutics for the following indication: Solid tumor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KT-333
- Announced Date:
- May 14, 2024
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 2024
- Indication:
- Solid tumor
Announcement
Kymera Therapeutics announced that KT-333 Phase 1 study ongoing with additional data expected in the second half of 2024,
AI Summary
Kymera Therapeutics announced that its Phase 1 study for KT-333, a first-in-class STAT3 degrader, is currently ongoing. The company shared new data on the drug’s safety, pharmacokinetics, and clinical responses, with additional information expected to be released in the second half of 2024. This study is focused on patients with various blood cancers and some solid tumors, showing promising signs of STAT3 degradation and possible clinical benefits.
Data from the recent EHA abstract, cut off as of February 6, 2024, suggested that KT-333 was well-tolerated and effective in reducing STAT3 levels. Kymera looks forward to completing the study and plans to present further updates on this innovative program later this year, which could help shape the next steps in the drug’s development.
Read Announcement- Drug:
- KT-333
- Announced Date:
- May 14, 2024
- Indication:
- Solid tumor
Announcement
Kymera Therapeutics, announced that new Phase 1 data for KT-333, a first-in-class degrader of STAT3, highlighting safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical responses will be presented at the European Hematology Association (EHA) Annual Meeting, taking place from June 13-16, 2024, in Madrid, Spain.
AI Summary
Kymera Therapeutics announced that new Phase 1 data for KT-333, a first-in-class degrader of STAT3, will be presented at the European Hematology Association Annual Meeting in Madrid, Spain, from June 13 to 16, 2024. The data, with a February 6, 2024 cut-off, highlights key findings related to safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical responses. Early results show that KT-333 effectively degrades STAT3 and modulates related pathways, supporting its potential in treating various cancers.
With 39 patients enrolled across multiple dose levels, the ongoing study provides promising insights into the tolerability and efficacy of KT-333 in targeting STAT3-driven diseases. Additional data on clinical responses and further assessments are expected as the Phase 1 study continues into the second half of 2024, marking an important milestone for this novel therapeutic approach.
Read Announcement
