Good morning, everyone,
Let's see what the Americans do this afternoon; I'll at least stay invested for now.
The FDA announced on September 25 Zilurgisertib (ATEBRIOZ) for adults and children 12 years and older with fibrodysplasia ossificans progressiva (FOP) . This means the previously anticipated PDUFA deadline is no longer just a possibility—approval has been granted.
Mirum Pharmaceuticals, Inc. – Nachrichten
Why it matters: This is a fundamental milestone: A pipeline candidate is becoming an approved drug. This opens up a new commercial revenue stream in addition to the existing liver franchise.
Even more importantly: Mirum announced today, September 28, held an additional investor call regarding the top-line results of the Phase 3 AZURE-1 study of Brelovitug for chronic hepatitis D . This is Mirum’s next major clinical milestone.
