Insmed reports Phase 3b ENCORE trial meets primary endpoint for ARIKAYCE in MAC lung disease

Reuters

03/23

<a href="https://laohu8.com/S/INSM">Insmed</a> reports Phase 3b ENCORE trial meets primary endpoint for ARIKAYCE in MAC lung disease

Insmed reported positive topline results from the Phase 3b ENCORE study evaluating ARIKAYCE 590 mg plus azithromycin 250 mg and ethambutol 15 mg/kg once daily versus placebo plus the same multidrug therapy in antibiotic-naive patients with a new occurrence of MAC lung infection.
The primary endpoint, change from baseline in Respiratory Symptom Score at Month 13, was 17.77 points with ARIKAYCE versus 14.66 points with placebo (p=0.0299).
Multiplicity-controlled secondary endpoints included culture conversion by Month 6 of 87.8% with ARIKAYCE versus 57.0% with placebo (p<0.0001).
Insmed said it plans to file a supplemental NDA for ARIKAYCE in the second half of 2026 and to submit the data to Japan’s PMDA in the second half of 2026 to support potential label changes.
The company said it plans to present the ENCORE data at a future medical congress.

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. Insmed Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202603230700PR_NEWS_USPR_____NY16178) on March 23, 2026, and is solely responsible for the information contained therein.

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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. Insmed Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202603230700PR_NEWS_USPR_____NY16178) on March 23, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"INSM","symbol_name":"Insmed","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260323:nNDL5qfctT:1","article_id":"2621777086","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2621777086","pubTimestamp":1774263928,"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":"Insmed reported positive topline results from the Phase 3b ENCORE study evaluating ARIKAYCE 590 mg plus azithromycin 250 mg and ethambutol 15 mg/kg once daily versus placebo plus the same multidrug therapy in antibiotic-naive patients with a new occurrence of MAC lung infection.The primary endpoint, change from baseline in Respiratory Symptom Score at Month 13, was 17.77 points with ARIKAYCE versus 14.66 points with placebo .Multiplicity-controlled secondary endpoints included culture conversion by Month 6 of 87.8% with ARIKAYCE versus 57.0% with placebo .Insmed said it plans to file a supplemental NDA for ARIKAYCE in the second half of 2026 and to submit the data to Japan’s PMDA in the second half of 2026 to support potential label changes.The company said it plans to present the ENCORE data at a future medical congress.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"INSM":"Insmed","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4139":"生物科技","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU0053671581.USD":"摩根大通美国小盘成长股 A(dist)","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)"},"translate_title":"Insmed报告ARIKAYCE治疗MAC肺病的3b期ENCORE试验达到了主要终点","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"INSM":0.9},"content_text":"Insmed reports Phase 3b ENCORE trial meets primary endpoint for ARIKAYCE in MAC lung disease\n    \n\n\n          Insmed reported positive topline results from the Phase 3b ENCORE study evaluating ARIKAYCE 590 mg plus azithromycin 250 mg and ethambutol 15 mg/kg once daily versus placebo plus the same multidrug therapy in antibiotic-naive patients with a new occurrence of MAC lung infection.\n        \n\n          The primary endpoint, change from baseline in Respiratory Symptom Score at Month 13, was 17.77 points with ARIKAYCE versus 14.66 points with placebo (p=0.0299).\n        \n\n          Multiplicity-controlled secondary endpoints included culture conversion by Month 6 of 87.8% with ARIKAYCE versus 57.0% with placebo (p<0.0001).\n        \n\n          Insmed said it plans to file a supplemental NDA for ARIKAYCE in the second half of 2026 and to submit the data to Japan’s PMDA in the second half of 2026 to support potential label changes.\n        \n\n          The company said it plans to present the ENCORE data at a future medical congress.\n        \n\n\n\n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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