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Insmed Inc (INSM.OQ)

INSM.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Insmed announces changes to its board of directors
Thursday, 8 Nov 2018 08:30am EST 

Nov 8 (Reuters) - Insmed Inc ::INSMED ANNOUNCES CHANGES TO ITS BOARD OF DIRECTORS.INSMED INC - CHIEF EXECUTIVE OFFICER WILL LEWIS ELECTED CHAIRMAN OF BOARD.INSMED INC - DONALD HAYDEN, JR. STEPS DOWN AS CHAIRMAN.INSMED INC - LEWIS WILL CONTINUE TO SERVE AS PRESIDENT AND CHIEF EXECUTIVE OFFICER OF COMPANY.  Full Article

Insmed Reports Q3 2018 Financial Results
Tuesday, 30 Oct 2018 07:30am EDT 

Oct 30 (Reuters) - Insmed Inc ::INSMED REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE.Q3 LOSS PER SHARE $1.14.Q3 EARNINGS PER SHARE VIEW $-1.06 -- THOMSON REUTERS I/B/E/S.AS OF SEPTEMBER 30, 2018, INSMED HAD CASH AND CASH EQUIVALENTS OF $567.6 MILLION.INSMED - SEES CASH-BASED OPERATING EXPENSES, CAPITAL, OTHER CASH INVESTMENTS TO BE TOWARD LOW END OF RANGE OF $150 MILLION-$170 MILLION FOR H2 2018.  Full Article

Insmed Inc - FDA Approves Insmed's Arikayce
Friday, 28 Sep 2018 05:22pm EDT 

Sept 28 (Reuters) - Insmed Inc ::FDA APPROVES A NEW ANTIBACTERIAL DRUG TO TREAT A SERIOUS LUNG DISEASE USING A NOVEL PATHWAY TO SPUR INNOVATION.FDA SAYS APPROVED A NEW DRUG, ARIKAYCE (AMIKACIN LIPOSOME INHALATION SUSPENSION).FDA SAYS GRANTED APPROVAL OF ARIKAYCE TO INSMED, INC.  Full Article

Insmed Announces FDA Acceptance For Filing Of NDA For Lung Disease Treatment
Wednesday, 16 May 2018 08:00am EDT 

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 08:00am EDT 

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 04:09pm EST 

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 07:30am EDT 

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
Wednesday, 6 Sep 2017 09:37pm EDT 

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's treatment-resistant lung disease drug gets FDA approval

The U.S. Food and Drug Administration on Friday approved Insmed Inc's lead drug to treat a rare, chronic lung disease, making it the first approved treatment in the United States for the condition.