- Nasdaq: ARDM
- Sector: Healthcare
- Industry: Specialty Pharmaceuticals
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases. Aradigm has completed two Phase 3 trials with Linhaliq, an investigational proprietary formulation of ciprofloxacin for inhalation for the treatment of non-cystic fibrosis BE and submitted an NDA to the FDA on July 27, 2017 for this indication. The FDA responded with a CLR regarding the NDA. As stated previously, we are committed to continuing to work on obtaining regulatory approval of Linhaliq in the US. On March 8, 2018Aradigm submitted a MAA to the EMA for the same indication which is validated and under review according to standard timelines. Aradigm’s inhaled ciprofloxacin formulations include Linhaliq and Lipoquin which are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.