Targeted Protein Degradation (TPD)
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KYMR Skyrockets 82.4% in a Year: More Upside Potential in 2026?
ZACKS· 2026-01-05 19:46
Key Takeaways KYMR surged after KT-621 showed deep STAT6 degradation and strong EASI and pruritus reductions.KT-621 cut multiple type 2 biomarkers and was mostly safe, supporting its potential as a once-daily therapy.FDA Fast Track and ongoing phase IIb AD and asthma studies position KT-621 for broader late-stage development.Kymera Therapeutics, Inc. (KYMR) has put up a stupendous performance over the past year. Shares of this clinical-stage biotechnology company have surged 82.4% over the said time frame c ...
Kymera's Eczema Drug Gets Fast Track Designation in the United States
ZACKS· 2025-12-12 16:30
Core Insights - Kymera Therapeutics, Inc. (KYMR) received FDA Fast Track designation for KT-621, aimed at treating moderate to severe atopic dermatitis, which is the most common form of eczema [1][8] - KYMR's stock increased by 4.23% in after-hours trading following the announcement [1] - KT-621 is a first-in-class, once-daily oral degrader of STAT6, a key transcription factor in Type 2 inflammation [1] FDA Designation - The Fast Track designation from the FDA accelerates the development and review process for drugs addressing serious conditions and unmet medical needs, allowing for frequent interactions with the FDA during clinical development [2] Clinical Development - Positive results were reported from the phase Ib study, BroADen AD, where KT-621 showed effectiveness across various measures, including STAT6 degradation and safety [3] - A phase IIb study, BROADEN2, is ongoing with data expected by mid-2027, and a phase IIb study for asthma is planned to start in Q1 2026 [4] Financial Performance - Kymera closed an upsized underwritten public offering, raising $602 million by selling 8,050,000 shares at $86 per share, with gross proceeds of approximately $692.3 million [5] - The company's stock has surged 64.1% year to date in 2025, outperforming the industry gain of 17.7% [6][7] Pipeline and Collaborations - Kymera is utilizing targeted protein degradation (TPD) to develop drugs for significant health issues, with promising progress in its pipeline [9] - In June 2025, Kymera entered an exclusive agreement with Gilead Sciences to develop a novel molecular glue degrader program targeting CDK2 for oncology applications [10][11] - Kymera also collaborates with Sanofi to advance its pipeline, with a candidate targeting IRAK4 selected for clinical studies [12]
Kymera Therapeutics Announces U.S. FDA Fast Track Designation for KT-621, a First-in-Class, Oral STAT6 Degrader for the Treatment of Atopic Dermatitis
Globenewswire· 2025-12-11 12:00
Core Insights - The FDA has granted Fast Track designation to KT-621, a first-in-class oral STAT6 degrader for treating moderate to severe atopic dermatitis (AD) [1][2][3] - KT-621 aims to provide a once-daily oral treatment option that matches the efficacy and safety of injectable biologics, addressing significant gaps in current treatment options for AD and other Type 2-driven diseases [2][4] - Positive results from the BroADen Phase 1b trial indicate KT-621's potential in treating Type 2 inflammatory diseases, with ongoing Phase 2b trials expected to yield data by mid-2027 [1][2][4] Company Overview - Kymera Therapeutics is a clinical-stage biopharmaceutical company focused on developing oral small molecule degrader medicines for immunological diseases [1][6] - The company has advanced the first degrader into clinical evaluation for immunological diseases and aims to build a leading pipeline of therapies [6] - Founded in 2016, Kymera has been recognized as one of Boston's top workplaces [6] Atopic Dermatitis Context - Atopic dermatitis is a chronic inflammatory disease that significantly impacts patients' quality of life, with a notable unmet need for improved treatment options [5] - Current treatments include topical therapies and injectable biologics, but many patients remain untreated [5]
Kymera Therapeutics Announces Pricing of Upsized $602 Million Public Offering
Globenewswire· 2025-12-10 04:30
Core Viewpoint - Kymera Therapeutics, Inc. has announced a public offering of $602.0 million in common stock to advance its pipeline of degrader programs and for general corporate purposes [1][2]. Group 1: Offering Details - Kymera is selling 7,000,000 shares at a public offering price of $86.00 per share, with an additional option for underwriters to purchase up to 1,050,000 shares [1]. - The gross proceeds from the offering are expected to be approximately $602.0 million before deducting underwriting discounts and commissions [1]. - The offering is anticipated to close on December 11, 2025, subject to customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance Kymera's pipeline of preclinical and clinical degrader programs targeting large patient populations and for working capital [2]. Group 3: Company Overview - Kymera Therapeutics is a clinical-stage biotechnology company focused on targeted protein degradation (TPD) to develop innovative medicines for immunological diseases [6]. - The company aims to provide a new generation of oral small molecule therapies that are highly effective and convenient for patients [6].
Kymera Therapeutics (NasdaqGM:KYMR) Earnings Call Presentation
2025-12-08 13:00
KT-621, Oral STAT6 Degrader, Phase 1b Results 1 Agenda Introduction Justine Koenigsberg Vice President, Investor Relations Revolutionizing Immunology with Oral Medicines Nello Mainolfi, PhD Founder, President and Chief Executive Officer KT-621 BroADen Phase 1b Data Jared Gollob, MD Chief Medical Officer Closing Remarks Nello Mainolfi, PhD Founder, President and Chief Executive Officer Question and Answer Session 2 Forward Looking Statements This presentation contains forward-looking statements within the me ...
Kymera Therapeutics to Announce KT-621 BroADen Phase 1b Atopic Dermatitis Trial Results on December 8, 2025
Globenewswire· 2025-12-05 21:01
Core Insights - Kymera Therapeutics, Inc. is set to announce results from the BroADen Phase 1b clinical trial for KT-621, an oral STAT6 degrader for atopic dermatitis, on December 8, 2025 [1] - KT-621 has shown complete STAT6 degradation and a favorable safety profile in early studies, indicating its potential to transform treatment for over 130 million patients with Type 2 inflammatory diseases [3] - Ongoing and planned clinical trials for KT-621 aim to accelerate its development across multiple indications, including asthma and other Type 2 diseases [4] Company Overview - Kymera Therapeutics is a clinical-stage biotechnology company focused on targeted protein degradation to develop innovative therapies for significant health issues [5] - The company has advanced the first degrader into clinical evaluation for immunological diseases and aims to build a robust pipeline of oral small molecule degraders [5] - Founded in 2016, Kymera has been recognized as one of Boston's top workplaces, reflecting its commitment to innovation and employee satisfaction [5]
C4 Therapeutics (NasdaqGS:CCCC) FY Conference Transcript
2025-12-03 21:27
Summary of C4 Therapeutics FY Conference Call Company Overview - C4 Therapeutics is a targeted protein degradation company focused on developing breakthrough medicines for patients with high unmet medical needs [3][4] - The company has two active clinical programs: - Cemsidomide (IKZF1/3 degrader) with data recently presented at IMS in Toronto, expected to enter the next phase of development early next year [3][4] - CFT8919 (EGFR L858R degrader) currently in a phase one first-in-human study in collaboration with Betta Pharmaceuticals in China [3][4] Clinical Program Updates - **Cemsidomide**: - Phase 1 dose escalation study showed an overall objective response rate (ORR) of 36% across 72 patients, with higher doses (75 micrograms and 100 micrograms) achieving ORRs of 40% and 53% respectively [6][7] - Median duration of treatment was 9.3 months, with a safety profile indicating only 6% of patients had dose reductions due to safety reasons [7][8] - 100% of patients were triple-class exposed, with 75% having prior CAR T or T cell engager therapy, showing consistent response rates across these subgroups [8][14] - **Comparison with Mezigdomide**: - Cemsidomide's response rate (53%) is competitive with mezigdomide (55%), but with a significantly better safety profile, as mezigdomide had higher rates of discontinuations and dose reductions due to safety [13][14] Future Development Plans - The company plans to advance Cemsidomide to the next phase of studies, with a meeting scheduled with the FDA to align on dosing [16][18] - The expected ORR for the upcoming 4L+ study is around 40%, based on a background rate of 20% [20] Financial and Strategic Considerations - C4 Therapeutics has a cash runway through the end of 2028, which does not include potential milestone payments of up to $40 million from collaboration partners [32] - The company is focused on moving Cemsidomide to the next phase while also supporting the ongoing study with Betta Pharmaceuticals [31][32] Commercial Considerations - Pricing for Cemsidomide is still under consideration, with the goal to be competitive based on the value it brings to patients [21] - The expected duration of response in a last-line setting is anticipated to be over six months, with current data showing 9.3 months [23] Combination Therapy Insights - C4 Therapeutics is exploring the combination of Cemsidomide with bispecific T-cell engagers, with evidence suggesting potential synergistic effects [24][25] - The study design will introduce Cemsidomide only after patients reach the loaded dose of the BiTE, with careful monitoring of safety and tolerability [26][27] Key Takeaways - C4 Therapeutics is making significant progress in its clinical programs, particularly with Cemsidomide, which shows promising efficacy and safety profiles compared to competitors - The company is strategically positioned for future growth with a solid financial runway and ongoing collaborations, while also preparing for potential commercial opportunities in the near future
Kymera Trades Near 52-Week High: Time to Buy, Sell or Hold the Stock?
ZACKS· 2025-11-26 13:36
Core Insights - Kymera Therapeutics, Inc. (KYMR) shares reached a 52-week high of $68.8 on November 24, currently trading at $66.04, driven by investor optimism surrounding its lead pipeline candidate KT-621 [1][7] - Year-to-date, KYMR shares have surged 64.1%, significantly outperforming the industry gain of 17.7% [1][2] Pipeline and Product Development - Kymera is utilizing targeted protein degradation (TPD) to develop drugs for critical health issues, with KT-621 being the first degrader in clinical evaluation for immunological diseases [5][6] - KT-621 is a first-in-class, once-daily oral degrader of STAT6, showing complete STAT6 degradation and reductions in type 2 inflammation biomarkers in a Phase I study [6][8] - The company has initiated a Phase IIb study, BROADEN2, for KT-621 in patients with moderate to severe atopic dermatitis, with data expected by mid-2027 [7][8] - Parallel Phase IIb studies for KT-621 in asthma are set to begin in Q1 2026, aiming to expedite its development [8][9] Strategic Partnerships - In June 2025, Kymera entered an exclusive agreement with Gilead Sciences to develop a novel molecular glue degrader targeting CDK2 for oncology applications [10][12] - Kymera also collaborates with Sanofi, which has selected KT-485 for clinical studies targeting IRAK4 for immuno-inflammatory diseases, while discontinuing KT-474 [13][15] Valuation and Financial Estimates - KYMR shares are currently overvalued with a price/book ratio of 4.99X, compared to the industry average of 3.49X [16] - The Zacks Consensus Estimate for 2025 loss per share has widened, while the estimate for 2026 loss has narrowed to $3.74 [17][19] Future Outlook - Positive data from the upcoming KT-621 study is anticipated to significantly boost the stock [20] - Existing investors are advised to hold, while prospective investors should seek a better entry point due to the long development timeline ahead [20][21]
Kymera Therapeutics Announces First Patient Dosed in BROADEN2 Phase 2b Atopic Dermatitis Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader
Globenewswire· 2025-11-25 12:00
Core Insights - Kymera Therapeutics has initiated dosing in the BROADEN2 Phase 2b clinical trial for KT-621, targeting moderate to severe atopic dermatitis (AD), with data expected by mid-2027 [1][2] - The company is also set to launch the BREADTH Phase 2b trial for asthma in Q1 2026, indicating a strategic focus on multiple Type 2 diseases [3][2] - KT-621 is a first-in-class oral degrader of STAT6, which plays a crucial role in Type 2 inflammation, and has shown promising results in early studies [4][2] Company Developments - The BROADEN2 trial is a randomized, double-blind, placebo-controlled study involving approximately 200 patients over 16 weeks, with primary and secondary endpoints focused on efficacy and safety measures [2][1] - The completion of dosing in the KT-621 BroADen Phase 1b trial is anticipated to yield data in December 2025, further supporting the development timeline for KT-621 [1][2] - The parallel development of KT-621 for both AD and asthma is expected to enhance the drug's market potential and facilitate dose selection for future Phase 3 studies [3][2] Product Information - KT-621 is designed to degrade STAT6, a transcription factor involved in IL-4/IL-13 signaling, which is central to Type 2 inflammatory diseases [4][2] - The investigational drug has demonstrated complete STAT6 degradation in early trials, along with a favorable safety profile compared to placebo [4][2] - The potential market for KT-621 includes over 130 million patients globally suffering from various Type 2 diseases, highlighting significant unmet medical needs [4][2] Industry Context - Atopic dermatitis is a prevalent chronic inflammatory condition that significantly impacts patients' quality of life, with existing treatments showing limitations [5][2] - The ongoing development of innovative therapies like KT-621 reflects the industry's shift towards targeted treatments for chronic immunological diseases [6][2]
Kymera Therapeutics Announces Third Quarter 2025 Financial Results and Provides a Business Update
Globenewswire· 2025-11-04 12:00
Core Insights - Kymera Therapeutics has made significant progress in its clinical trials, particularly with KT-621, which is the first STAT6-directed agent for atopic dermatitis (AD) patients, with data expected in December 2025 [1][2][3] - The company is well-capitalized with $979 million in cash as of September 30, 2025, providing a runway into the second half of 2028 [1][14] - Upcoming milestones include the initiation of the KT-621 BROADEN2 Phase 2b trial in AD and the BREADTH Phase 2b trial in asthma, both expected to accelerate development across multiple indications [2][9] Clinical Development Updates - Enrollment and dosing have been completed in the KT-621 BroADen Phase 1b trial for moderate to severe AD, with results anticipated in December 2025 [1][3] - The KT-621 BROADEN2 Phase 2b trial has been initiated, evaluating three doses in approximately 200 patients over 16 weeks, with data expected by mid-2027 [3][4] - KT-579, an oral degrader of IRF5, has completed IND-enabling studies, with a Phase 1 clinical trial expected to start in early 2026 [1][10] Financial Performance - Collaboration revenues for Q3 2025 were $2.8 million, down from $3.7 million in Q3 2024, primarily from the collaboration with Gilead Sciences [11] - Research and development expenses increased to $74.1 million in Q3 2025 from $60.4 million in Q3 2024, driven by investments in the STAT6 program [12] - The net loss for Q3 2025 was $82.2 million, compared to $62.5 million in Q3 2024, with cash and cash equivalents totaling $978.7 million as of September 30, 2025 [14][22]