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OS THERAPIES INC (OSTX)

(19% Negative) OS THERAPIES INC (OSTX) Announces Delay in leader Trials for non-dilutive VAT refunds from wholly owned U Due to Regulatory Process, Efficacy Assessment

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  • News bot April 2, 2026, 9:26 p.m.

    📋 OS THERAPIES INC (OSTX) - Clinical Trial Update

    Filing Date: 2026-04-02

    Accepted: 2026-04-02 17:25:09

    Event Type: Clinical Trial Update

    Event Details:

    OS THERAPIES INC (OSTX) Announces Clinical Trial Update OS THERAPIES INC (OSTX) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: leader, approvals
    • Diseases/Conditions: non-dilutive VAT refunds from wholly owned U, 2H-26 ●Offering net proceeds
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Regulatory Process
    • Collaboration: VAT
      • targeting the HER2 protein. OST-HER2 has received Orphan Drug Designation (ODD), Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and has received ODD, FTD and ATMP from the European Medicines Agency. The Company reported positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study and the overall survival (OS) secondary endpoint. The Company anticipates receiving a Biologics License Application (BLA) from the U.S. FDA for OST-HER2 in osteosarcoma in 2026

    🔬 Clinical Development Pipeline (OS THERAPIES INC):

    Product Type Development Stage Therapeutic Area Source
    Placebo OTHER Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    ITI-333 DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Risperidone DRUG Phase PHASE2 Schizophrenia ClinicalTrials.gov
    ITI-007 (Lumateperone) DRUG Phase PHASE3 Bipolar Depression ClinicalTrials.gov
    ITI-214 DRUG Phase PHASE1 Parkinson Disease ClinicalTrials.gov
    ITI-007 DRUG Phase PHASE3 Schizophrenia ClinicalTrials.gov
    Imitation Surgical Procedure (ISP) OTHER Phase PHASE1 Parkinson Disease ClinicalTrials.gov
    OXB-102 DRUG Phase PHASE1 Parkinson Disease ClinicalTrials.gov
    Lumateperone Long-Acting Injectable DRUG Phase PHASE1 Schizophrenia ClinicalTrials.gov
    Lumateperone (ITI-007) DRUG Phase PHASE3 Bipolar Depression ClinicalTrials.gov
    Lumateperone 28 mg DRUG Phase PHASE1 Schizophrenia ClinicalTrials.gov
    Lumateperone 21 mg ODT DRUG Phase PHASE1 Autism Spectrum Disorder ClinicalTrials.gov
    Lumateperone 15.5 mg ODT DRUG Phase PHASE1 Autism Spectrum Disorder ClinicalTrials.gov
    Lumateperone 10.5 mg ODT DRUG Phase PHASE1 Autism Spectrum Disorder ClinicalTrials.gov
    Lumateperone 5 mg ODT DRUG Phase PHASE1 Autism Spectrum Disorder ClinicalTrials.gov
    Lumateperone 21 mg capsule DRUG Phase PHASE1 Autism Spectrum Disorder ClinicalTrials.gov
    Lumateperone 10.5 mg capsule DRUG Phase PHASE1 Autism Spectrum Disorder ClinicalTrials.gov
    ITI-1284 DRUG Phase PHASE2 Psychosis Associated With Alzheimer's Disease ClinicalTrials.gov
    Lumateperone 42 mg DRUG Phase PHASE1 Schizophrenia ClinicalTrials.gov
    Placebos DRUG Phase PHASE3 Bipolar Depression ClinicalTrials.gov
    ITI-1284 20 mg DRUG Phase PHASE2 Generalized Anxiety Disorder ClinicalTrials.gov
    ITI-1284 10 mg DRUG Phase PHASE2 Generalized Anxiety Disorder ClinicalTrials.gov
    Lumateperone LAI DRUG Phase PHASE1 Schizophrenia or Schizoaffective ClinicalTrials.gov
    Lumateperone Capsule DRUG Phase PHASE1 Schizophrenia or Schizoaffective ClinicalTrials.gov
    [14C]-ITI-1284 DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Lenrispodun DRUG Phase PHASE2 Parkinson Disease ClinicalTrials.gov
    Lumateperone low dose DRUG Phase PHASE3 Irritability Associated With Autism Spectrum Disorder ClinicalTrials.gov
    Lumateperone high dose DRUG Phase PHASE3 Irritability Associated With Autism Spectrum Disorder ClinicalTrials.gov
    Lumateperone DRUG Phase PHASE3 Major Depressive Disorder ClinicalTrials.gov
    Caplyta DRUG Phase PHASE2 Borderline Personality Disorder ClinicalTrials.gov

    💼 Business Developments:

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

    Structured Data:

    • Company Name: OS THERAPIES INC
    • Ticker Symbol: OSTX

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