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Harmony Biosciences (HRMY)

(10% Negative) Harmony Biosciences (HRMY) Announces Delay in Trials Trials for San Francisco Due to Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Jan. 29, 2026, 8:06 p.m.

    📋 Harmony Biosciences (HRMY) - Clinical Trial Update

    Filing Date: 2026-01-12

    Accepted: 2026-01-12 08:20:14

    Event Type: Clinical Trial Update

    Event Details:

    Harmony Biosciences (HRMY) Announces Clinical Trial Update Harmony Biosciences (HRMY) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: Trials, BILLION
    • Diseases/Conditions: San Francisco, Five Distinct CNS IndicationsPLYMOUTH MEETING
    • Clinical Stage: Phase 1 Trial, Phase 1
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Patient Enrollment, Regulatory Process
    • Collaboration: Harmony Biosciences Holdings, Inc.
    • Updated Timeline: full year 2025
      • Expected in Mid-2026
      • targeting central 5- hydroxytryptamine receptors to modulate serotonin signaling. The drug candidate is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform.DS is caused by a loss of function mutation in the SCN1A gene, and scn1 mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of DS patients. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system.About Dravet SyndromeDravet syndrome (DS) is a severe and progressive epileptic encephalopathy that begins in infancy and causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and a risk of sudden unexpected death in epilepsy. Approximately 85% of Dravet syndrome cases are caused by de novo loss-of-function (LOF) mutations in a voltage-gated sodium channel gene, SCN1A1. DS has an estimated incidence rate of 1:15,700.About Lennox-Gastaut SyndromeLennox-Gastaut syndrome (LGS) is a rare and drug-resistant epileptic encephalopathy characterized by onset in children between 3-5 years of age. The underlying cause of LGS is unknown and can be related to a wide range of factors including genetic differences and structural differences in the brain.As a result, patients experience multiple seizure types, including atonic seizures, and developmental, cognitive, and behavioral issues. LGS affects approximately 48,000 patients in the U.S.About Harmony BiosciencesHarmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017
      • anticipated in 1H 2027

    🔬 Clinical Development Pipeline (Harmony Biosciences):

    Product Type Development Stage Therapeutic Area Source
    Comparator Products DRUG Preclinical Pregnancy Related ClinicalTrials.gov
    Placebo oral tablet DRUG Phase PHASE2 Prader-Willi Syndrome ClinicalTrials.gov
    Pitolisant oral tablets DRUG Phase PHASE2 Prader-Willi Syndrome ClinicalTrials.gov
    Pitolisant DRUG Phase PHASE3 Idiopathic Hypersomnia ClinicalTrials.gov
    HBS-201 DRUG Phase PHASE1 Narcolepsy ClinicalTrials.gov
    Placebo DRUG Phase PHASE3 Lennox Gastaut Syndrome ClinicalTrials.gov
    Clemizole HCl DRUG Phase PHASE3 Lennox Gastaut Syndrome ClinicalTrials.gov
    Placebo tablet OTHER Phase PHASE3 Prader-Willi Syndrome ClinicalTrials.gov
    Pitolisant tablet DRUG Phase PHASE3 Prader-Willi Syndrome ClinicalTrials.gov
    Double-blind pitolisant DRUG Phase PHASE3 Idiopathic Hypersomnia ClinicalTrials.gov
    Double-blind placebo DRUG Phase PHASE3 Idiopathic Hypersomnia ClinicalTrials.gov
    Open-label pitolisant DRUG Phase PHASE3 Idiopathic Hypersomnia ClinicalTrials.gov
    Pitolisant Oral Tablet DRUG Phase PHASE2 Myotonic Dystrophy 1 ClinicalTrials.gov
    Part 2 DRUG Phase PHASE1 Drug Interaction ClinicalTrials.gov
    Part 1 DRUG Phase PHASE1 Drug Interaction ClinicalTrials.gov

    💼 Business Developments:

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

    Structured Data:

    • Company Name: Harmony Biosciences
    • Ticker Symbol: HRMY

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