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BIOMEA FUSION, INC. (BMEA)

(10% Negative) BIOMEA FUSION, INC. (BMEA) Announces Delay in results Trials for advancing to chronic clinical dosing Due to Patient Enrollment Issues, Regulatory Process, Safety Review

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  • News bot May 11, 2026, 8:59 p.m.

    📋 BIOMEA FUSION, INC. (BMEA) - Clinical Trial Update

    Filing Date: 2026-05-11

    Accepted: 2026-05-11 16:58:18

    Event Type: Clinical Trial Update

    Event Details:

    BIOMEA FUSION, INC. (BMEA) Announces Clinical Trial Update BIOMEA FUSION, INC. (BMEA) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: results, studies
    • Diseases/Conditions: advancing to chronic clinical dosing, type 1 diabetes (“T1D”)
    • Clinical Stage: Phase I, clinical trial
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Patient Enrollment, Regulatory Process
    • Collaboration: GLOBE NEWSWIRE
      • expected in the second quarter of 2026
      • Targeting Menin for Diabetes•Chronic toxicology studies in two species were successfully completed for icovamenib, providing nonclinical support for chronic clinical dosing beyond the 12-week duration used to date; findings demonstrated a favorable safety profile consistent with previously reported preclinical and clinical data.•With more than 400 subjects dosed to date, icovamenib was generally well tolerated and demonstrated a favorable safety profile throughout the observation periods.•Two Phase II clinical trials evaluating icovamenib in T2D have been initiated and enrollment is ongoing: •COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled trial in patients with insulin-deficient T2D not achieving glycemic targets despite standard of care therapy. •COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled trial in patients with T2D not achieving glycemic targets while on a GLP-1 RA-based therapy. •Both trials include a 26-week primary endpoint, with topline data anticipated in the fourth quarter of 2026
      • anticipated in the second quarter of 2026

    🔬 Clinical Development Pipeline (BIOMEA FUSION, INC.):

    Product Type Development Stage Therapeutic Area Source
    Placebo Other Phase PHASE2 Type 2 Diabetes ClinicalTrials.gov
    BMF-650 Other Phase PHASE1 Obesity ClinicalTrials.gov
    Icovamenib HPMC Other Phase PHASE1 Healthy Volunteer ClinicalTrials.gov
    BMF-219 Other Phase PHASE1 Non Small Cell Lung Cancer ClinicalTrials.gov
    Icovamenib Other Phase PHASE1 Healthy Volunteer ClinicalTrials.gov
    BMF-500 Other Phase PHASE1 Acute Myeloid Leukemia ClinicalTrials.gov
    icovamenib 100 mg Other Phase PHASE2 Type 2 Diabetes ClinicalTrials.gov
    icovamenib 100mg Other Phase PHASE2 Type 2 Diabetes ClinicalTrials.gov

    💼 Business Developments:

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

    Structured Data:

    • Company Name: BIOMEA FUSION, INC.
    • Ticker Symbol: BMEA

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