Development and Regulatory status
Aug 18: The FDA had agreed to consider a filing based on PIIb trials in 2016. Mallinckrodt will now meet with the FDA to discuss potential paths forward in the coming months .
Aug 18: Not approved by US FDA. A complete response letter outlining areas of further evaluation to be considered before resubmitting an application for approval of the first-in-class heme oxygenase inhibitor has been issued .
Aug 18: This was filed in the US. FDA have set an action date of August 18 for stannsoporfin for the treatment of neonates at risk for developing severe jaundice (hyperbilirubinemia). 
Aug 18: The drug received Fast Track status. ·
Trial or other data
Mar 16: PII JASMINE_204 study (NCT01887327) to evaluate two doses of stannsoporfin in combination with phototherapy in 91 infants in the US completes .
Feb 13: PIII study (NCT02685137) to assess a single intramuscular injection of stannsoporfin compared to "sham" (placebo) in 185 healthy term and near-term newborns admitted to the well-baby nursery in the US completes .
PIII trials expected to start 2009, after InfaCarepharma secured $28M to advance development for neonatal hyperbilirubinaemia (1).·