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
Insmed Incorporated (INSM)
Last insmed incorporated earnings: 4/30 07:30 am
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Source: GlobeNewswire
--As previously reported, study met primary endpoint of culture conversion (p --ALIS under FDA Priority Review with PDUFA action date of September 28, 2018-- BRIDGEWATER, N.J., Sept. 17, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that data from the pivotal Phase 3 CONVERT study evaluating the safety and efficacy of ALIS (amikacin liposome inhalation suspension) in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) were published online in the American Journal of Respiratory and Critical Care Medicine. The study showed that the addition of ALIS to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum cultures by Month 6 in 29.0% of patients (65/224), compared to 8.9% of patients (10/112) on GBT alone (p NTM lung disease is a chronic, de
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INSM
Earnings
- 2/22/24 - Miss
INSM
Sec Filings
- 4/1/24 - Form DEFA14A
- 4/1/24 - Form DEF
- 3/11/24 - Form 8-K
- INSM's page on the SEC website