MannKind Announces Clearance from PMDA to Initiate Phase 3 Clinical Trial (ICoN-1) in Japan Evaluating Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (...
MannKind Corporation (MNKD)
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Source: GlobeNewswire
Clearance to proceed also received from health authorities in South Korea and Australia, with Taiwan expected in 4Q 2024First U.S. patient randomized DANBURY, Conn., Sept. 18, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to initiate the Phase 3 study (ICoN-1) of Clofazimine Inhalation Suspension for the treatment of NTM lung disease. The global study is now cleared by health authorities to proceed in four countries (U.S., Japan, South Korea and Australia) with a fifth (Taiwan) expected in 4Q 2024. “We are pleased to initiate the ICoN-1 study in Japan in an effort to further develop potential therapy for those living with serious NTM lung infections,” said Dr. Kozo Morimoto, lead principal in
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News
- MannKind Showcases Efficacy, Safety, and Mealtime Control Data from Recent Pediatric and Adult Studies of Afrezza® at the ATTD Conference, March 19-22 [Yahoo! Finance]Yahoo! Finance
- MannKind Showcases Efficacy, Safety, and Mealtime Control Data from Recent Pediatric and Adult Studies of Afrezza® at the ATTD Conference, March 19-22GlobeNewswire
- MannKind Co. (NASDAQ: MNKD) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
- MannKind Corporation Earnings Missed Analyst Estimates: Here's What Analysts Are Forecasting Now [Yahoo! Finance]Yahoo! Finance
- MannKind Co. (NASDAQ: MNKD) had its "outperform" rating re-affirmed by analysts at Wedbush. They now have a $11.00 price target on the stock.MarketBeat
MNKD
Earnings
- 2/26/25 - Beat
MNKD
Sec Filings
- 2/26/25 - Form S-3ASR
- 2/26/25 - Form 10-K
- 2/26/25 - Form 8-K
- MNKD's page on the SEC website