Harmony Biosciences Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation

Reuters

2025/11/24

<a href="https://laohu8.com/S/HRMY">Harmony Biosciences</a> Reports Positive Bioequivalence Results for Pitolisant Gastro-Resistant Formulation

Harmony Biosciences Holdings Inc. announced positive results from a pivotal bioequivalence study evaluating its gastro-resistant (GR) formulation of pitolisant. The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX® (pitolisant) tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251124261066) on November 24, 2025, and is solely responsible for the information contained therein.

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The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX® (pitolisant) tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251124261066) on November 24, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"製藥","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251124:nNDL5wVlz2:1","article_id":"2585462974","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2585462974","pubTimestamp":1763989520,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Harmony Biosciences Holdings Inc. announced positive results from a pivotal bioequivalence study evaluating its gastro-resistant  formulation of pitolisant. The study demonstrated that the 17.8 mg pitolisant GR formulation is bioequivalent to the existing 17.8 mg WAKIX  tablets, with comparable AUC and Cmax values. The company also reported that a dosing optimization study showed 100% of patients were able to initiate treatment at the therapeutic dose without the need for titration. No new safety or tolerability issues were observed in the studies. Harmony plans to submit a New Drug Application for pitolisant GR in early 2026, with a targeted PDUFA date in the first quarter of 2027. Results from these studies have already been announced.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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