BridgeBio initiates rolling submission of U.S. application for BBP-870

BridgeBio (BBIO +1.4%) launches its rolling NDA filing with the FDA seeking approval to use fosdenopterin (BBP-870/ORGN001) to treat patients with an ultra-rare inherited metabolic disorder called molybdenum cofactor deficiency type A (MoCD Type A), characterized by irreversible brain damage in newborns.

Fosdenopterin is a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy designed to reduce the buildup of toxic sulfites thereby alleviating central nervous system symptoms in MoCD Type A sufferers. It has Orphan Drug, Rare Pediatric Disease Designation and Breakthrough Therapy status in the U.S. for the indication.

https://seekingalpha.com/news/3523338-bridgebio-initiates-rolling-submission-of-u-s-application-for-bbpminus-870-in-mocd-type