MannKind Announces IND Clearance From U.S. FDA to Start Phase 3 Study of Clofazimine Inhalation Suspension for Nontuberculous Mycobacterial (NTM) Lung Disease
MannKind Corporation (MNKD)
Last mannkind corporation earnings: 2/25 08:00 am
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Source: GlobeNewswire
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 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 the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Phase 3 study for the treatment of nontuberculous mycobacterial (NTM) lung disease. “Oral clofazimine has been utilized as a treatment option for patients living with NTM lung disease and we believe that by reducing the dose and administering it directly to the lung we can demonstrate improved dosing, tolerability and safety,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Advancing this program to a Phase 3 trial, we are encouraged that MNKD-101 could poten
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MNKD
Earnings
- 5/8/24 - Beat
MNKD
Sec Filings
- 5/14/24 - Form 4
- 5/14/24 - Form 4
- 5/14/24 - Form 4
- MNKD's page on the SEC website