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Apogee Therapeutics Inc (APGE)

(90% Positive) Apogee Therapeutics, Inc. (APGE) Announces Enrollment Update for zumilokibart Due to Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment

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  • News bot Jan. 6, 2026, 12:02 p.m.

    📋 Apogee Therapeutics, Inc. (APGE) - Clinical Trial Update

    Filing Date: 2026-01-06

    Accepted: 2026-01-06 07:00:45

    Event Type: Clinical Trial Update

    Event Details:

    Apogee Therapeutics Inc (APGE) Announces Clinical Trial Update Apogee Therapeutics Inc (APGE) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: zumilokibart
    • Clinical Stage: Phase 3, Phase 2
    • Collaboration: FeNO
    • Updated Timeline: Q1 2026, Q2 2026
      • targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com. Forward Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: the potential for zumilokibart (APG777) in asthma; Apogee’s plans for its current and future product candidates and programs; the anticipated timing of its clinical trials, including the APEX 52-week Part A in AD, APEX 16-week Part B in AD, APG279 Phase 1b head-to-head readout against DUPIXENT in AD, the potential Phase 3 trial of zumilokibart and the potential launch of zumilokibart; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of zumilokibart and APG279; the potential to expand zumilokibart for other indications; Apogee’s other product candidates, including combination therapies, and any other potential programs; its planned business strategies; potential market sizes; and its expectations regarding the time period over which Apogee’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on Form 10-K for the year ended December 31, 2024
      • expected in Q1 2026
      • targeting both IL-13 and OX40L. With these readouts, Apogee expects to generate data across monotherapy and combination programs in 2026

    🔬 Clinical Development Pipeline (Apogee Therapeutics, Inc.):

    Product Type Development Stage Therapeutic Area Source
    APG990 DRUG Phase PHASE1 Atopic Dermatitis ClinicalTrials.gov
    Placebo DRUG Phase PHASE2 Atopic Dermatitis ClinicalTrials.gov
    APG777 DRUG Phase PHASE2 Atopic Dermatitis ClinicalTrials.gov
    Dupilumab DRUG Phase PHASE1 Atopic Dermatitis ClinicalTrials.gov

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Apogee Therapeutics Inc
    • CIK: 0001974640
    • Ticker Symbol: APGE
    • Period End Date: 2026-01-06
    • Document Type: 8-K

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