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    Pitolisant Hydrochloride

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    FDA Approves WAKIX for Pediatric Cataplexy
    FDA Approves WAKIX for Pediatric Cataplexy

    17 Feb 2026

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20260217839280/en/Harmony-Biosciences-Receives-U.S.-Food-and-Drug-Administration-Approval-for-WAKIX-pitolisant-for-the-Treatment-of-Cataplexy-in-Pediatric-Narcolepsy

    BUSINESSWIRE
    17 Feb 2026
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    Harmony Announces Positive Bioequivalence Data For Pitolisant
    Harmony Announces Positive Bioequivalence Data For Pitolisant

    24 Nov 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20251124261066/en/Harmony-Biosciences-Announces-Positive-Results-From-the-Pivotal-Bioequivalence-Study-for-Pitolisant-Gastro-Resistant-Formulation

    BUSINESSWIRE
    24 Nov 2025
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    Viatris Completes Acquisition of Aculys Pharma
    Viatris Completes Acquisition of Aculys Pharma

    15 Oct 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/viatris-completes-acquisition-of-aculys-pharma-including-exclusive-rights-to-pitolisant-in-japan-and-to-spydia-in-japan-and-certain-other-markets-in-the-asia-pacific-region-302585421.html

    PR NEWSWIRE
    15 Oct 2025
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    Harmony Biosciences Strengthens Patent Position with Settlement
    Harmony Biosciences Strengthens Patent Position with Settlement

    05 Jun 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250605623408/en/Harmony-Biosciences-Strengthens-Patent-Position-With-Favorable-Settlement-in-ANDA-Litigation

    BUSINESSWIRE
    05 Jun 2025
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    Harmony Updates SNDA Status For Pitolisant In Idiopathic Hypersomnia
    Harmony Updates SNDA Status For Pitolisant In Idiopathic Hypersomnia

    19 Feb 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250219512387/en

    BUSINESSWIRE
    19 Feb 2025
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    HARMONY BIOSCIENCES Acknowledges FDA Action on WAKIX® Citizen Petition
    HARMONY BIOSCIENCES Acknowledges FDA Action on WAKIX® Citizen Petition

    25 Jun 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/harmony-biosciences-acknowledges-us-food--drug-administration-fda-action-denying-the-citizen-petition-for-wakix-pitolsiant-302181609.html

    PR NEWSWIRE
    25 Jun 2024
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