Aerovate Therapeutics Inc (AVTE)

(10% Negative) AEROVATE THERAPEUTICS, INC. (AVTE) Announces Delay in enthusiasm Trials for our Phase 2b/Phase 3 trial Due to Pandemic-Related Challenges, Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Oct. 1, 2025, 8:15 p.m.

    📋 AEROVATE THERAPEUTICS, INC. (AVTE) - Clinical Trial Update

    Filing Date: 2022-05-16

    Accepted: 2022-05-16 08:00:44

    Event Type: Clinical Trial Update

    Event Details:

    Aerovate Therapeutics Inc (AVTE) Announces Clinical Trial Update Aerovate Therapeutics Inc (AVTE) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: enthusiasm, people
    • Diseases/Conditions: our Phase 2b/Phase 3 trial
    • Clinical Stage: Phase 3, clinical trial
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Pandemic-Related Challenges, Patient Enrollment, Regulatory Process, Regulatory Timeline
    • Collaboration: SVP
    • Updated Timeline: the fourth quarter of 2023 or first quarter of 2024
      • 101, our dry powder inhaled formulation of the anti
      • proliferative drug imatinib for the treatment of pulmonary arterial hypertension (PAH), a devastating disease impacting approximately 70,000 people in the United States and Europe. With IMPAHCT now active at multiple sites, investigators and key opinion leaders continue to express enthusiasm for our Phase 2b/Phase 3 trial. However, we are experiencing site initiation delays as a result of clinical trial site staff shortages and COVID
      • term interruptions. Because of these delays, we expect to report topline data from the Phase 2b portion of the trial in the fourth quarter of 2023 or first quarter of

    💼 Business Developments:

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

    Structured Data:

    • Company Name: Aerovate Therapeutics Inc
    • CIK: 0001798749
    • Ticker Symbol: AVTE
    • Period End Date: 2022-05-16
    • Document Type: 8-K