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Insmed Inc (INSM.OQ)

INSM.OQ on NASDAQ Stock Exchange Global Select Market

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20 Jun 2018
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Latest Key Developments (Source: Significant Developments)

Insmed Announces FDA Acceptance For Filing Of NDA For Lung Disease Treatment
Wednesday, 16 May 2018 

May 16 (Reuters) - Insmed Inc ::INSMED ANNOUNCES FDA ACCEPTANCE FOR FILING OF NEW DRUG APPLICATION FOR ALIS IN NTM LUNG DISEASE CAUSED BY MAC.INSMED INC - PDUFA ACTION DATE SET FOR SEPTEMBER 28, 2018.  Full Article

Insmed Inc Submits NDA To FDA For ALIS
Thursday, 29 Mar 2018 

March 29 (Reuters) - Insmed Inc ::INSMED SUBMITS NEW DRUG APPLICATION TO FDA FOR ALIS IN NTM LUNG DISEASE CAUSED BY MAC.INSMED - ANTICIPATES RECEIVING A SIX-MONTH PRIORITY REVIEW AND THAT NDA WILL BE REVIEWED BY DIVISION OF ANTI-INFECTIVE PRODUCTS.  Full Article

Insmed Announces Additional Data From ALIS Phase 3 Clinical Program
Wednesday, 3 Jan 2018 

Jan 3 (Reuters) - Insmed Inc ::INSMED ANNOUNCES ADDITIONAL DATA FROM ALIS (AMIKACIN LIPOSOME INHALATION SUSPENSION) PHASE 3 CLINICAL PROGRAM FOR ADULT PATIENTS WITH TREATMENT REFRACTORY NTM LUNG DISEASE CAUSED BY MAC AND REPORTS PROGRESS WITH COMMERCIAL PREPARATIONS.INSMED INC - COMPANY TARGETING SUBMISSION OF NDA BEFORE END OF MARCH.INSMED - REGULATORY ACTIVITIES AND PRE-COMMERCIAL EXPANSION ONGOING TO SUPPORT ANTICIPATED US COMMERCIAL LAUNCH OF ALIS IN LATE 2018.INSMED INC - ‍REMAINS ON TRACK TO FILE ITS NDA FOR ACCELERATED APPROVAL OF ALIS WITH U.S. FDA BEFORE END OF MARCH​.INSMED - INS-312 DATA SHOWS 28% PATIENTS EARLIER GOT 6 MONTHS OF GBT ALONE ACHIEVED CULTURE CONVERSION AFTER ADDITION OF ALIS TO THERAPY.INSMED INC - ‍PLANS TO RECONFIRM WITH PMDA APPROVAL PATH FOR ALIS IN JAPAN BASED ON CLINICAL DATA​.INSMED INC - ‍PLANS TO FILE AN APPLICATION WITH PMDA IN LATE 2018 OR EARLY 2019​.  Full Article

Insmed Q3 loss per share $0.69
Thursday, 2 Nov 2017 

Nov 2 (Reuters) - Insmed Inc :Insmed reports third quarter 2017 financial results and provides business update.Q3 loss per share $0.69.Q3 earnings per share view $-0.69 -- Thomson Reuters I/B/E/S.  Full Article

Insmed says offering of 12.3 million common shares priced at $28.50per share
Thursday, 7 Sep 2017 

Sept 6 (Reuters) - Insmed Inc -:Insmed announces pricing of public offering of common stock.Says offering of 12.3 million common shares priced at $28.50per share.  Full Article

Insmed announces worldwide license agreement with AstraZeneca for oral DPP1 inhibitor
Wednesday, 5 Oct 2016 

Insmed Inc : Insmed will pay AstraZeneca an upfront payment of $30 million . Agreement provides AstraZeneca with option to negotiate a future agreement with Insmed for commercialization of AZD7986/ins1007 . Continue to expect patient enrollment in phase 3 study of Arikayce to conclude later this year and to report top line data in 2017 . Confirms its cash operating expense guidance for second half of 2016 of $62 million to $72 million . In a phase 1 study of healthy volunteers AZD7986 was well tolerated . Says AstraZeneca will be eligible to receive future payments totaling $120 mln in future clinical, regulatory, and sales-related milestones .Confirms its cash operating expense guidance for second half of 2016 of $62 to $72 million..  Full Article

Insmed Q2 loss per share $0.59
Thursday, 4 Aug 2016 

Insmed Inc : Q2 loss per share $0.59 . Insmed reports second quarter 2016 financial results .Q2 earnings per share view $-0.56 -- Thomson Reuters I/B/E/S.  Full Article

BRIEF-Insmed Announces FDA Acceptance For Filing Of NDA For Lung Disease Treatment

* INSMED ANNOUNCES FDA ACCEPTANCE FOR FILING OF NEW DRUG APPLICATION FOR ALIS IN NTM LUNG DISEASE CAUSED BY MAC