#ARIKAYCE
Insmed Announces Significant Respiratory Data Presentations at CHEST and IDWeek 2026#None#Insmed#CHEST_2026#IDWeek_2026
Insmed Announces Significant Respiratory Data Presentations at CHEST and IDWeek 2026
Insmed will unveil new respiratory data at CHEST 2026 and IDWeek 2026, focusing on groundbreaking treatments like TPIP and ARIKAYCE.
third-news.com
October 14, 2026 at 11:21 AM
【ARIKAYCEの正式承認申請、FDAが優先審査】
Insmedのアミカシンリポソーム吸入。MAC肺症に対する一部変更承認申請が優先審査になった。PDUFAは2027年1月28日。加速承認から正式承認へ進める申請であり、いま承認が下りた話ではない。
FDA、Insmedの「ARIKAYCE」正式承認申請を優先審査に指定──MAC肺症へのsNDA、審査完了目標日は2027年1月28日
stellanews.life/technology/1...
FDA、Insmedの「ARIKAYCE」正式承認申請を優先審査に指定──MAC肺症へのsNDA、審査完了目標日は2027年1月28日
米国食品医薬品局(FDA)は、Insmed社の吸入抗菌薬アミカシンリポソーム吸入用懸濁液(ARIKAYCE)について、MAC(Mycobacterium avium complex)肺症を対象とした正式承認(フル承認)を求める一部変更承認申請(sNDA)を優先審査に指定し、審査完了目標日を2027年1月28日に設定した。
stellanews.life
September 28, 2026 at 4:08 AM
【未治療のMAC肺疾患、ARIKAYCEの第3b相をERSで報告】
Insmedが欧州呼吸器学会で、新規診断のMAC肺疾患にアミカシンリポソーム吸入と多剤併用を12カ月投与したENCORE試験をlate-breakingで出す。微生物学的転帰と再発率が主題。本記事は演題発表の告知で、数値の全文ではない。
Insmedが呼吸器領域データを欧州呼吸器学会議2026で発表──ARIKAYCE第3b相ENCORE試験の最新結果を整理
stellanews.life/technology/1...
Insmedが呼吸器領域データを欧州呼吸器学会議2026で発表──ARIKAYCE第3b相ENCORE試験の最新結果を整理
Insmedは2026年9月3日、欧州呼吸器学会議(ERS Congress)2026において、ARIKAYCE(アミカシンリポソーム吸入用懸濁液)の第3b相ENCORE試験結果を含む呼吸器ポートフォリオ関連の5演題が採択されたと発表した。新規MAC肺疾患患者における微生物学的転帰と再発率などの内容を整理する。
stellanews.life
September 21, 2026 at 10:44 PM
Insmed's ARIKAYCE® Receives FDA Priority Review for Treating MAC Lung Disease#United_States#Bridgewater#Insmed#ARIKAYCE#MAC_Lung_Disease
Insmed's ARIKAYCE® Receives FDA Priority Review for Treating MAC Lung Disease
Insmed's ARIKAYCE® has received FDA Priority Review for treating MAC lung disease, with a target date for full approval set for January 2027.
third-news.com
September 21, 2026 at 11:13 AM
【MAC肺疾患、ARIKAYCEの第3b相をERSで報告】
Insmed。新規診断例にアミカシンリポソーム吸入と多剤併用を12カ月。微生物学的転帰と再発率がlate-breaking。
September 14, 2026 at 10:51 PM
【新診断MAC肺疾患、ARIKAYCEの第3b相をERSで】
InsmedがENCORE試験をlate-breaking発表。アジスロマイシン・エタンブトールとの12カ月併用で、微生物学的転帰と再発を評価した。
September 7, 2026 at 10:26 PM
Insmed to Showcase Key Findings from Its Respiratory Portfolio at ERS Congress 2026#USA#Bridgewater#Insmed#ARIKAYCE#Brinsupri
Insmed to Showcase Key Findings from Its Respiratory Portfolio at ERS Congress 2026
Insmed will present crucial data from its respiratory portfolio, including significant findings from the Phase 3b ENCORE study on ARIKAYCE and other therapies, at the ERS Congress 2026.
third-news.com
September 3, 2026 at 11:16 AM
Insmed's Second-Quarter 2026 Financial Performance Outshines Expectations with Impressive Revenue Growth#United_States#Bridgewater#Insmed#ARIKAYCE#Brinsupri
Insmed's Second-Quarter 2026 Financial Performance Outshines Expectations with Impressive Revenue Growth
Insmed reports significant revenue growth in Q2 2026, driven by thriving sales of BRINSUPRI and ARIKAYCE. The company sets ambitious revenue guidance for 2026.
third-news.com
August 6, 2026 at 11:21 AM
Insmed Welcomes Samuele Butera as Senior Vice President to Lead Global Respiratory Division#United_States#Bridgewater#Insmed#ARIKAYCE#Samuele_Butera
Insmed Welcomes Samuele Butera as Senior Vice President to Lead Global Respiratory Division
Insmed has appointed Samuele Butera as Senior VP and General Manager for Global Respiratory. His extensive experience aims to elevate patient care through innovative therapies.
third-news.com
June 23, 2026 at 11:21 AM
Insmed (INSM) Outlook After Yahoo’s Apr 11, 2026 Call: Yahoo Finance named Insmed a "Top QQQ stock" on Apr 11, 2026; INSM market cap near $2.8bn and ARIKAYCE FDA-approved Nov 2, 2018 — institutional implications detailed. 👈 Read full analysis #Insmed #INSM #YahooFinance #FDAApproved #MarketCap
Insmed (INSM) Outlook After Yahoo’s Apr 11, 2026 Call
Yahoo Finance named Insmed a "Top QQQ stock" on Apr 11, 2026; INSM market cap near $2.8bn and ARIKAYCE FDA-approved Nov 2, 2018 — institutional implications detailed.
dlvr.it
April 11, 2026 at 6:54 PM
Positive confirmatory results for Arikayce @insmed support plans for an sNDA to expand into antibiotic-naïve MAC lung disease and convert accelerated to traditional approval, with a parallel PMDA submission planned. Learn more:
ENCORE: ARIKAYCE Meets End Points, Improves Respiration in MAC Lung Disease | HCPLive
Phase 3b ENCORE shows inhaled ARIKAYCE boosts culture conversion and symptoms in antibiotic‑naïve MAC lung disease, paving way for 2026 label expansion.
www.hcplive.com
March 25, 2026 at 12:00 PM
Feed: "Clinical Trials Arena"
By: Annabel Kartal Allen on Tuesday, March 24, 2026
Insmed eyes Arikayce label expansion on Phase IIIb lung disease success
Insmed will now seek Arikayce’s approval in the US and Japan for use in earlier lines of MAC lung infection treatment.
www.clinicaltrialsarena.com
March 24, 2026 at 7:18 PM