On May 11, 2020, Bellerophon Therapeutics announced the FDA accepted its Investigational New Drug (IND) application, allowing the Company to initiate a Phase 3 study of INOpulse inhaled nitric oxide (iNO) therapy in up to 500 patients infected with COVID-19.

The IND acceptance follows agreement by the FDA earlier this year to allow investigational treatment with INOpulse for COVID-19 patients under emergency expanded access. To date, over 50 patients with COVID-19 have received treatment with INOpulse under the care and supervision of their physicians.