Kymera Therapeutics, Inc.

Fast Track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis (AD) patient trial KT-621 BROADEN2 Phase 2b AD trial ongoing, with data expected to be reported by mid-2027 and BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 Dec. 11, 2025 -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today 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). “Atopic dermatitis is a chronic, debilitating disease. Far too many patients are currently untreated and are looking for new options. Receiving Fast Track designation will allow us to explore ways to accelerate the development of KT-621 and reflects the immense opportunity to advance a first-in-industry oral therapy that could address significant gaps within the current treatment landscape,” said Nello Mainolfi, PhD, Founder, President and CEO of Kymera Therapeutics. “Our goal with KT-621 is to deliver a once-a-day oral medicine with the activity and safety of injectable biologics, but in a far more convenient format – broadening access and supporting better outcomes for the millions of adults and children affected by AD and other Type 2-driven diseases around the world.” The Company recently reported positive results from the BroADen Phase 1b AD trial, in which KT-621 demonstrated the potential to provide a once-daily oral treatment for Type 2 inflammatory diseases across every measure evaluated, including STAT6 degradation, biomarker modulation, clinical activity, impact on comorbid Type 2 diseases, and safety. The KT-621 BROADEN2 Phase 2b trial in moderate to severe AD patients is ongoing, with data expected to be reported by mid-2027. The BREADTH Phase 2b trial in asthma is planned to start in the first quarter of 2026. These studies are intended to accelerate KT-621 development and enable dose selection for subsequent parallel Phase 3 registration studies across multiple Type 2 dermatology, gastroenterology and respiratory indications. The FDA’s Fast Track process is designed to get important new medicines to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development and potentially accelerated approval and/or priority review, if relevant criteria are met. 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 the Phase 1 clinical study in atopic dermatitis 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 paradigms for more than 140 million patients around the world, including children and adults, suffering from Type 2 diseases such as atopic dermatitis (AD), asthma, bullous pemphigoid (BP), chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others. Atopic dermatitis (AD) is the most common form of eczema, a chronic inflammatory disease that causes the skin to become inflamed and irritated, making it extremely pruritic (itchy). AD occurs most frequently in children but also affects adults. It can affect a patient’s quality of life and lead to additional complications, such as infections and sleep loss. While there are currently available medicines for AD, such as topical therapies and injectable biologics, there remains a significant unmet need and opportunity to improve treatment options for millions of patients. 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. 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Kymera Therapeutics has announced positive results from its trial of KT-621 to treat patients with moderate to severe atopic dermatitis (AD). STAT6 drives the inflammatory response in the blood and skin, and KT-621 works by reducing the levels of STAT6 in the blood and skin. The phase 1b BroADen trial included 22 people with moderate to severe AD over 28 days, with a 14-day follow-up period. In the trial, KT-621 reduced the levels of STAT6 in the blood and skin significantly, and this reduction remained consistent. At day 29, the average reduction of STAT6 in the blood was 98%, and for skin lesions – an area with high levels of STAT6 – the average reduction of STAT6 was 94%. In addition, at day 29, the Eczema Area and Severity Index (EASI) score was reduced by 63% for all patients. Various type 2 biomarkers associated with inflammatory response were also found to have been reduced. The safety and tolerability profiles of KT-621 were favourable, with no serious adverse events being reported. Nello Mainolfi, founder, president and CEO of Kymera, said: “The BroADen study results exceeded our highest expectations and provide a powerful additional validation of our industry-leading STAT6 degrader programme. “KT-621 demonstrated its potential to deliver a first-in-class, once-a-day oral treatment for type 2 inflammatory diseases across every measure we evaluated, including STAT6 degradation, biomarker modulation, clinical activity, impact on other comorbid type 2 diseases and safety.” Atopic dermatitis is a chronic skin condition characterised by itchy, inflamed and discoloured skin. As well as causing physical discomfort and pain, it can lead to embarrassment and social isolation.

A record-setting $3.2 billion in biotech follow-on stock offerings were sold over the last 24 hours, another indication of public investors’ appetite for the sector. From late Tuesday evening into Wednesday morning, eight biotechs priced sales of new stocks , and seven of those companies increased their offering sizes to meet demand, with Structure Therapeutics, Terns Pharmaceuticals and Kymera Therapeutics each raising more than $600 million. “$3.2bn of biotech equity issuance makes yesterday the busiest day ever,” said Jack Bannister, Leerink’s senior managing director in equity capital markets, who tracks company offerings. “There have been busier weeks than this week, but yesterday was the busiest day ever,” Bannister said by email. The stock sales follow positive data readouts by the companies in obesity, sickle cell disease and leukemia. Investors have been piling into companies with good data, hoping in part to ride an increase in M&A and licensing activity amid a dearth of IPOs where they might otherwise place bets. And they reflect a rebound in biotech stocks to heights not seen since the Covid-19 pandemic. The S&P’s biotech index, the XBI, is up 10% over the past month and 42% over the past six months. Wednesday’s capital markets haul surpasses that of other big days in the history of biotech follow-on offerings. Two days in May 2020 each saw more than $2 billion in activity, according to Bruce Booth, a biotech investor at Atlas Venture. The positive momentum has also seeped into the startup world, with 27 megarounds disclosed since Sept. 30, according to an Endpoints News tally. The wealth has been spread across biotechs in the US, Europe and China , where biopharma dealmaking activity is hotter than ever. Along with Kymera, Structure and Terns, other companies selling offerings included Wave Life Sciences, Dyne Therapeutics, Vera Therapeutics, Denali Therapeutics and Fulcrum Therapeutics. Editor’s note: The side of Terns’ offer and sale has been corrected.