Moderna and Merck's mRNA Cancer Vaccine Wins Phase 3 — But There's No Filing Date

Intismeran autogene plus KEYTRUDA met its primary and key secondary endpoints in the 1,137-patient Phase 3 INTerpath-001 melanoma trial — the first Phase 3 win for a neoantigen mRNA cancer therapy — as Moderna added roughly $44 billion in market value in a single session. Also: FDA approves Regeneron's Pasatru for fibrodysplasia ossificans progressiva at about $1.4 million a year, setting up a fight with Ipsen's Sohonos; Ultragenyx wins its first gene therapy approval for glycogen storage disease type Ia; Xspray Pharma takes a third Complete Response Letter on Dasynoc over contract manufacturing; and Roche commits $750 million to its Genentech site in Hillsboro, Oregon. Visit us at thepharmacloseout.com.