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 Treatm...
Insmed Incorporated (INSM)
Last insmed incorporated earnings: 4/30 07:30 am
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Source: GlobeNewswire
--Advisory committee supports surrogate endpoint of sputum culture conversion-- --ALIS currently under FDA Priority Review; PDUFA action date set for September 28, 2018-- BRIDGEWATER, N.J., Aug. 07, 2018 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted 12 to 2 in favor of the safety and effectiveness of ALIS (amikacin liposome inhalation suspension) for adults with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who have limited or no treatment options. The committee also voted in favor of the surrogate endpoint of sputum culture conversion used in the Phase 3 CONVERT study being reasonably likely to predict clinical benefit. If approved, ALIS will be the first and only therapy in the U.S. specifically indicated for the treatment
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News
- Insmed to Host First-Quarter 2024 Financial Results Conference Call on Thursday, May 9, 2024PR Newswire
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- Insmed Incorporated (NASDAQ: INSM) had its price target raised by analysts at Barclays PLC from $37.00 to $40.00. They now have an "overweight" rating on the stock.MarketBeat
- What Makes Insmed (INSM) a Lucrative Investment? [Yahoo! Finance]Yahoo! Finance
- Insmed Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)PR Newswire
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