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  • News bot June 23, 2026, 8:29 p.m.

    📋 TALPHERA, INC. (TLPH) - Regulatory Update

    Filing Date: 2026-06-23

    Accepted: 2026-06-23 16:27:15

    Event Type: Regulatory Update

    Event Details:

    TALPHERA, INC. (TLPH) Announces Regulatory Update TALPHERA, INC. (TLPH) provided an update on regulatory developments for its product portfolio. Regulatory Update Details: None Clinical Development:

    🔬 Clinical Development Pipeline (TALPHERA, INC.):

    Product Type Development Stage Therapeutic Area Source
    Placebo Tablet Other Phase PHASE3 Post-Operative Pain ClinicalTrials.gov
    Sufentanil Tablet 30 mcg Other Phase PHASE3 Post-Operative Pain ClinicalTrials.gov
    Treatment D: SSM 30 mcg Drug Phase PHASE1 Healthy ClinicalTrials.gov
    Treatment C: SSM 15 mcg Drug Phase PHASE1 Healthy ClinicalTrials.gov
    Treatment B: Sufentanil SSM 30 mcg Drug Phase PHASE1 Healthy ClinicalTrials.gov
    Treatment Arm A: Sufenta® Drug Phase PHASE1 Healthy ClinicalTrials.gov
    Placebo NanoTab Other Phase PHASE2 Acute Pain ClinicalTrials.gov
    Sufentanil NanoTab 30 mcg Other Phase PHASE2 Acute Pain ClinicalTrials.gov
    Sufentanil NanoTab 20 mcg Other Phase PHASE2 Acute Pain ClinicalTrials.gov
    40 consecutive doses of SUF NT 15 mcg taken every 20 minutes Other Phase PHASE1 Plasma Concentrations ClinicalTrials.gov
    Single dose of SUF NT 15 mcg Other Phase PHASE1 Plasma Concentrations ClinicalTrials.gov
    Treatment D: Sufentanil NanoTab Oral Drug Phase PHASE1 Pharmacokinetics ClinicalTrials.gov
    Treatment C: Sufentanil NanoTab Buccal Drug Phase PHASE1 Pharmacokinetics ClinicalTrials.gov
    Treatment B: Sufentanil NanoTab Sublingual Drug Phase PHASE1 Pharmacokinetics ClinicalTrials.gov
    Treatment A: Sufentanil IV Drug Phase PHASE1 Pharmacokinetics ClinicalTrials.gov
    morphine IV PCA Other Phase PHASE3 Post-Operative Pain ClinicalTrials.gov
    Sufentanil NanoTab PCA System/15 mcg Other Phase PHASE3 Post-Operative Pain ClinicalTrials.gov
    Placebo Sufentanil NanoTab PCA System Other Phase PHASE3 Post Operative Pain ClinicalTrials.gov
    Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg Other Phase PHASE1 Pharmacokinetics ClinicalTrials.gov
    Sufentanil NanoTab (SUF NT) 15 mcg Other Phase PHASE1 Pharmacokinetics ClinicalTrials.gov
    sufentanil sublingual tablet 30 mcg Other Phase PHASE3 Acute Moderate-to-severe Pain ClinicalTrials.gov
    sufentanil sublingual 30 mcg tablet Other Phase PHASE3 Moderate-to-severe Acute Pain ClinicalTrials.gov
    Zalviso™ 15 mcg Other Phase PHASE3 Moderate-to-severe Acute Pain ClinicalTrials.gov
    Placebo (0.9% NaCl) Other Approved Acute Kidney Injury ClinicalTrials.gov
    Niyad (nafamostat mesylate) Other Approved Acute Kidney Injury ClinicalTrials.gov
    Placebo NanoTab™ DRUG Phase PHASE2 Sedation ClinicalTrials.gov
    Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) DRUG Phase PHASE2 Sedation ClinicalTrials.gov
    Sublingual sufentanil NanoTabs™ and placebo NanoTabs™ DRUG Phase PHASE2 Cancer ClinicalTrials.gov
    Placebo DRUG Phase PHASE2 Major Upper or Lower Abdominal Surgery ClinicalTrials.gov
    Oral sufentanil DRUG Phase PHASE2 Major Upper or Lower Abdominal Surgery ClinicalTrials.gov
    Sufentanil NanoTab DRUG Phase PHASE2 Post Operative Pain ClinicalTrials.gov

    💼 Business Developments:

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

    Structured Data:

    • Company Name: TALPHERA, INC.
    • Ticker Symbol: TLPH

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