BridgeBio LLC
NEWS
With two decisions originally scheduled for this week already announced, including BridgeBio’s approval in ATTR-CM, the regulator has just one PDUFA on its plate this holiday week.
BridgeBio secured approval for Attruby Friday, along with the all-important mortality benefit that could give the drug a significant boost in the market against Pfizer’s tafamidis and potentially Alnylam’s Amvuttra.
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
With the help of third-party investors, the new venture will focus on three genetic and rare diseases: tuberous sclerosis complex, erythropoietic protoporphyria and alpha-A1 antitrypsin deficiency.
BridgeBio’s oral small molecule infigratinib is proceeding with a late-stage study in children with achondroplasia after it improved body proportionality and height in children with dwarfism, the company announced Tuesday.
Additional analyses from BridgeBio Pharma’s late-stage study show the oral drug candidate improved clinical outcomes in transthyretin amyloid cardiomyopathy patients.
The new company, BridgeBio Oncology Therapeutics, is looking to advance two KRAS inhibitors and a blocker of the interaction between the RAS and PI3K pathways.
As BridgeBio’s acoramidis inches closer to an FDA approval decision, Bayer on Monday inked a European licensing agreement for the transthyretin amyloid cardiomyopathy treatment.
Kyowa Kirin’s dealmaking continued on Wednesday when BridgeBio Pharma granted the Japanese company an exclusive license to develop and commercialize infigratinib.
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