Completed private placement financing of up to approximately $49 million to advance pulmonary hypertension program Auxora Phase 1b proof-of-concept data in pulmonary arterial hypertension (PAH) and...
FDA aligned on new-onset severe respiratory failure as the Phase 2b primary endpoint, with multi-organ failure and time to medically indicated discharge as key secondary endpoints
Proceeds expected to support a focused pulmonary hypertension strategy, including a Phase 1b proof-of-concept study evaluating Auxora™ in PAH, with data anticipated mid-2027, and advancement of oral...
FDA reviewed a protocol amendment and interim safety data from the KOURAGE trial evaluating Auxora in AKI patients
FDA feedback on the Auxora™ pivotal program in acute pancreatitis and potential future development in acute kidney injury expected in 2Q 2026
Internal and external reviews of all available safety data from the Phase 2 KOURAGE trial in acute kidney injury (AKI) did not identify evidence of a drug-related toxicity with Auxora™
Safety concern warrants reevaluation of study design, including enrollment criteria
Enrollment ongoing in Phase 2 KOURAGE trial of Auxora™ in acute kidney injury (AKI) with respiratory failure; data expected in 1H 2026
Preclinical data support CRAC channel inhibitor, CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension (PAH), both as monotherapy and in combination with existing...
Treatment with Auxora significantly reduced IL-17–related inflammation in both kidney and lung, significantly increased glomerular filtration rate (GFR), and decreased renal injury in a rat model of...