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News Releases

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  • Mar 27, 2019
    Insmed Announces Management Changes
  • Mar 4, 2019
    Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
  • Feb 22, 2019
    Insmed Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update
    --ARIKAYCE® (amikacin liposome inhalation suspension) U.S. Net Product Sales of $9.2 Million for the Fourth Quarter and Full Year 2018--
  • Feb 20, 2019
    Insmed to Present at the Leerink Partners 8th Annual Global Healthcare Conference
  • Feb 15, 2019
    Insmed to Host Fourth Quarter and Full Year 2018 Financial Results Conference Call on Friday, February 22, 2019
  • Feb 4, 2019
    Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
  • Jan 7, 2019
    Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
  • Jan 4, 2019
    Insmed Provides Update on ARIKAYCE® (amikacin liposome inhalation suspension) U.S. Launch and Outlines Strategic Priorities for 2019
    -ARIKAYCE Preliminary Unaudited U.S. Net Product Sales Approximately $9.2 Million for the Fourth Quarter of 2018-
  • Dec 4, 2018
    Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
  • Nov 8, 2018
    Insmed Announces Changes to its Board of Directors
    —Seasoned Pharmaceutical Executive Elizabeth McKee Anderson Appointed as New Director—
  • Nov 6, 2018
    Insmed to Present at Three November Conferences
  • Oct 30, 2018
    Insmed Reports Third Quarter 2018 Financial Results and Provides Business Update
    —Quarter Highlighted by U.S. FDA Approval of ARIKAYCE® (amikacin liposome inhalation suspension), Followed by Immediate Launch—
  • Oct 23, 2018
    Insmed to Host Third Quarter 2018 Financial Results Conference Call on Tuesday, October 30, 2018
  • Oct 11, 2018
    Insmed Presents New Data at IDWeek 2018 and CHEST Annual Meeting Enhancing the Understanding of MAC Lung Disease and Treatment with ARIKAYCE® (amikacin liposome inhalation suspension)
  • Oct 4, 2018
    Insmed Extends Patent Protection in Japan to 2033
    New Patent Adds 7 ½ Years of Market Exclusivity in Japan
  • Oct 1, 2018
    Insmed to Present at Two October Conferences
  • Sep 28, 2018
    Insmed Announces FDA Approval of ARIKAYCE® (amikacin liposome inhalation suspension), the First and Only Therapy Specifically Indicated for the Treatment of Mycobacterium Avium Complex (MAC) Lung Disease in Adult Patients with Limited or No Alternative Treatment Options
    Commercial availability expected in early Q4 2018
  • Sep 17, 2018
    Pivotal Phase 3 Data from CONVERT Study of ALIS in Patients with Treatment-Refractory NTM Lung Disease Caused by MAC Published in American Journal of Respiratory and Critical Care Medicine
    As previously reported, study met primary endpoint of culture conversion (p<0.0001)
  • Aug 27, 2018
    FDA Advisory Committee Votes 12-2 in Favor of the Safety and Effectiveness of Insmed’s ALIS for the Treatment of NTM Lung Disease Caused by MAC for Adult Patients with Limited or No Treatment Options
    Advisory committee supports surrogate endpoint of sputum culture conversion
  • Aug 2, 2018
    Insmed Reports Second Quarter 2018 Financial Results and Provides Business Update
    PDUFA (Prescription Drug User Fee Act) Action Date for ALIS (Amikacin Liposome Inhalation Suspension) Set for September 28, 2018
  • Jul 26, 2018
    Insmed to Host Second Quarter 2018 Financial Results Conference Call on Thursday, August 2, 2018
  • Jun 15, 2018
    Insmed Announces FDA Advisory Committee Meeting to Review ALIS as a treatment for NTM Lung Disease Caused by MAC
    Meeting planned for August 7, 2018
  • Jun 7, 2018
    Insmed to Present at Three June Conferences
  • May 22, 2018
    Insmed Announces Presentations at the American Thoracic Society 2018 International Conference
    Data support the benefit of treating patients with a combination of ALIS (Amikacin Liposome Inhalation Suspension) and guideline-based therapy (GBT) for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC)
  • May 17, 2018
    Insmed Appoints Leo Lee to its Board of Directors
  • May 16, 2018
    Insmed Announces FDA Acceptance for Filing of New Drug Application for ALIS in NTM Lung Disease Caused by MAC
    PDUFA Action Date Set for September 28, 2018
  • May 2, 2018
    Insmed Reports First Quarter 2018 Financial Results and Provides Business Update
    Submitted NDA to FDA for Amikacin Liposome Inhalation Suspension (ALIS) in NTM lung disease caused by MAC; anticipates priority review
  • May 1, 2018
    Insmed to Present at the Deutsche Bank 43rd Annual Health Care Conference
  • Apr 25, 2018
    Insmed to Host First Quarter 2018 Financial Results Conference Call on Wednesday, May 2, 2018
  • Mar 29, 2018
    Insmed Submits New Drug Application to FDA for ALIS in NTM Lung Disease Caused by MAC
    ALIS previously designated as an orphan drug, breakthrough therapy and Qualified Infectious Disease Product (QIDP)
  • Mar 7, 2018
    Insmed to Present at the Cowen and Company 38th Annual Health Care Conference
  • Feb 23, 2018
    Insmed Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update
    On track to file NDA before the end of March and anticipate a priority review
  • Feb 21, 2018
    Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
  • Feb 20, 2018
    Insmed Extends ALIS Intellectual Property Protection to 2035 with Issuance of Ninth U.S. Patent
  • Feb 15, 2018
    Insmed to Host Fourth Quarter and Full Year 2017 Financial Results Conference Call on Friday, February 23, 2018
  • Feb 7, 2018
    Insmed to Present at the Leerink Partners 7th Annual Global Healthcare Conference
  • Jan 26, 2018
    Insmed Announces Closing of Public Offering
  • Jan 24, 2018
    Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
  • Jan 23, 2018
    Insmed Announces Pricing of Public Offering of Convertible Senior Notes
  • Jan 22, 2018
    Insmed Announces Proposed Public Offering of Convertible Senior Notes
  • Jan 3, 2018
    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
    Interim results from INS-312 show that 28% of patients who previously received 6 months of guideline based therapy (GBT) alone achieved culture conversion following addition of ALIS to therapy, consistent with data from the INS-212 study
  • Nov 28, 2017
    Insmed to Present at the Nasdaq 37th Annual Investor Conference
  • Nov 22, 2017
    Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
  • Nov 8, 2017
    Insmed to Present at Two November Conferences
  • Nov 2, 2017
    Insmed Reports Third Quarter 2017 Financial Results and Provides Business Update
    During the third quarter, the Company announced positive top-line results from its Phase 3 CONVERT Study of ALIS (amikacin liposome inhalation suspension) in patients with NTM lung disease caused by MAC, a rare, progressive, destructive lung infection
  • Oct 25, 2017
    Insmed to Host Third Quarter 2017 Financial Results Conference Call on Thursday, November 2, 2017
  • Sep 19, 2017
    Insmed to Present at Two September Investor Conferences
  • Sep 11, 2017
    Insmed Announces Closing of Public Offering
  • Sep 6, 2017
    Insmed Announces Pricing of Public Offering of Common Stock
  • Sep 5, 2017
    Insmed Announces Positive Top-Line Results from Phase 3 CONVERT Study of ALIS (Amikacin Liposome Inhalation Suspension) in Adult Patients with Treatment-Refractory Nontuberculous Mycobacterial (NTM) Lung Disease Caused by Mycobacterium Avium Complex (MAC)
    Study met primary endpoint of culture conversion (p < 0.0001)
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