January 3, 2018 / 9:28 PM / 16 days ago

BRIEF-Insmed Announces Additional Data From ALIS Phase 3 Clinical Program

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​ Source text for Eikon: Further company coverage:

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